341 Properties White powder or granulate, content of sodium CMC calculated on bone dry basis > 99.

5 %, pH of 1 % solution 6.58.0, decomposition temperature approx. 240. Applications For pharmaceutical formulations and cosmetic products like toothpaste. Toxicology LD50 (rat, oral) > 27 000 mg/kg, non irritant, non mutagenic, non carcinogenic. Celacol HE (Celanese) Definition Trade name for various hydroxyethylcellulose products, water-soluble hydrocolloids. Applications For the manufacture of gelatinous products or viscous solutions. Celacol HEM (Celanese) Definition Trade name for 3 different kinds of water-soluble hydroxyethyl methyl cellulose with different degrees of viscosity, which contain about 2 % bound hydroxyethyl groups in addition to the methoxy groups. Properties Available as powder, fibrous material or granules (HEM 1000 only as fiber). The moisture content is approx. 810 %. HEM 450, viscosity (all of the following data refer to 2 % aqueous solutions) 350550 cP, HEM 1000, viscosity 8501150 cP, HEM 2500, viscosity 22002800 cP. All C. HEM types are characterized by a higher tolerance to salt than the corresponding Celacol methylcellulose types and are also more hydrophilic. Applications They are recommended as suspending, thickening and stabilizing agents etc. Celacol HPM (Celanese) Definition Trade name for hydroxypropyl methylcellulose. Celacol methylcellulose (Celanese) Definition Trade name for methylcellulose products, which yield solutions of varying viscosity and are suitable as special types for the manufacture of foods or pharmaceutical preparations. Properties Moisture content 810 %, content of arsenic < 1.0 ppm, copper < 15.5 ppm, lead < 5.0 ppm, zinc < 50 ppm, free from dimethyl sulfate. The following types are offered: M. 20, powder or fibers, viscosity (all of the following values apply to 2 % aqueous solutions) 1525 cP, M. 100, powder or fibers, viscosity 85115 cP, M. 450, powder, fibers or granules, viscosity 350550 cP, M. 1000, powder or fibers, viscosity 8501150 cP, M. 2500, powder, fibers or granules, viscosity 22002800 cP, MM. 10, fibers, viscosity 911 cP, MM. 100, fibers, viscosity 85115 cP, MM. 1000, powder or fibers, viscosity 850 1150 cP. Applications C. M. 450 is primarily suitable as a tablet binder (0.52.0 %), for the manufacture of mucilage preparations, laxatives etc. The other types are used for the manufacture of a wide range of suspensions, of O/W emulsions (23 %), capsules, ointments (M. 2500 or M. 1000), oil-containing creams or lotions (M. 100 or M.

Cel
450, 25 %), eye and ear drops, contact lense solutions (a 1 % M. 2500 solution has the same nD as the eye mucosa), of antacid preparations etc. Celacol Powder DS (Celanese) Definition A hydroxypropyl methylcellulose with a mol wt of approx. 100 000. Properties Giving highly viscous solutions even at low concentrations, resulting in a non sticky film on the skin. Celite (Johns Manville) Definition CAS 61790-53-2, Kieselgur, filter aid. The following types are available: C. 500, 512, 545 and 560 (H. Kranich and R. J. Zilli, Soap Chem. Specialties 42, (12), 73 [1966]). Cellactose 80 (Meggle) Definition Trade name for a spray-dried compound of 75 % -lactose monohydrate (Ph Eur, USP/NF, JP) and 25 % cellulose powder (Ph Eur). See SEM picture.

Properties A white, odorless powder, partly soluble in water. High compactability, high dilution and adherence potential. Product data Assay: lactose 73.077.0 %, cellulose powder 23.027.0 %, pH-value 4.07.0, loss on drying max. 3.5 %, water 4.07.0 %, residue on ignition max. 0.2 %, heavy metals max. 5 ppm, OVIs conform. Microbiological status: aerobic count max. 11/g, yeasts and moulds max. 10/g, E. coli negative/10 g, S. ssp. negative/ 10 g. Particle size distribution: < 32 m max. 20 %, < 160 m 3565 %, < 250 m min. 80 %. Angle of repose 32 35, bulk density 0.38 g/ml, tapped density 0.47 g/ml, Hausner ratio 1.24. Applications Direct compression aid for high dosage forms, especially cores for coating. Cellofas B (ICI) Definition Sodium carboxymethylcellulose, nonionic thickener ( cellulose gum).

Cod
frequently stated opinion that C. or other fish oils are suitable for preventing arteriosclerosis has not been sufficiently demonstrated according to G. Schlierf (Dtsch. med. Wschr. 112, 701 [1987]). According to studies by Al-Meshal et al. performed in rats, C. is able to prevent the inhibition of mucous secretion by the gastric mucosa induced by indomethacin (Life Sci. 48, 1401 [1991]; Toxicol. Abstr. 14, No. 8-4902 [1991]). Toxicology C. may contain toxaphene, also called camphechlor. Toxaphene (approx. C19H10Cl8, mol wt approx. 414, mp 6595, LD50 (rat, oral) 80 mg/kg) is a chlorinated camphene which is used as an insecticide. It has been agreed that the T. content of C. shall be 0.4 mg/kg (Pharm. Ztg. 136, 2215 [1991]). Analytics HPLC method for the determination of vitamin D3 in medicinal C. (D. Ropte and M. Neumann, Zbl. Pharm. 124, 331 [1985]). Cod liver oil fatty acid ethyl ester Definition INCI Ethyl Morrhuate, CAS 73049-58-8. Coffee whiteners Definition Non-dairy creamers. Applications Substitutes for coffee cream that are manufactured from vegetable fats and are very fashionable in the USA (cf. Norda Schimmel Briefs No. 440, April 1972); some formulations for manufacturing C. are given in this brief. Co-Fix (Cosmetochem) Definition Trade name for a base for hair setting lotions, a mixture of partially quaternized mixed vinyl resin polymers and hydantoin resins. Solid content approx. 24 %. Applications As a resin base or as an additive to hair setting lotions for achieving particularly adhesive clear and colored hair setting lotions. Different forms of C. are available (dissolved in isopropyl alcohol-water or only in water). Concentration 510 %. Co-Flex (Cosmetochem) Definition Trade name for a hairspray additive for weatherproof hairsprays. A combination of a mixed vinyl resin polymer containing hydroxybenzophenone together with wool wax fractions, cholesterol and silicones. Solids approx. 25 %. C. is offered in various solution systems. Applications C. is intended to be used as an additive to hairsprays in order to reduce the moisture sensitivity of hair and to increase its elasticity. C. is also a coating which protects from UV light. Concentration 0.50.6 % (related to the finished product). Colamine Definition Synonym for ethanolamine. COLIPA Definition C. is the European Trade Association representing the interests of the cosmetic, toiletry and perfumery industry. C. membership consists of 22 national associations out of 25 EU member states and 26 international companies. C. represents more than 2000 companies and

404 the industry employs over 500,000 people within the European Union. www.colipa.org. References Guidelines for the Evaluation of the Efficacy of Cosmetic Products, 2nd Edition, COLIPA (The European Cosmetic Toiletry and Perfumery Association), 2001. Colla piscium Definition Isinglass Collagen (Gelita, Pentapharm) Definition Ossein, a scleroprotein, a simple fibrillar protein substance, CAS 9007-34-5, mol wt 130 000. Properties Scleroproteins are intercellular main constituents of mesenchymal support substances. The scleroproteins include C. (which occurs in connective tissue, in tendons, ligaments, bone, cartilage and skin), elastin (tendons, elastic fibers, blood vessels, connective tissues), keratins (hair, nails, skin), silk fibroin (cocoon filaments of the silkworm moth) and skeletines (halogen-containing scleroproteins, skeletal substance of invertebrate animals). C. dissolves in water upon prolonged heating and forms a colloidal soluble glue, which solidifies on cooling. The gelatin thus obtained can be enzymatically cleaved. Properties (P. Morganti et al., J. Appl. Cosmetol. 4, No. 4, 141 [1986] [it]; C. A. 107, 140861 [1987]) and (T. Miyata, Fragrance J. 17, 90, 109 [1989] [jap]; C. A. 111, 59908 and 09 [1989]). Product data Pentapharm offers C. with the following product data: a viscous, slightly opalescant, colorless to slightly yellow colored solution containing 1 % C. in citrate buffer pH 3.43.8, with 0.15 % benzoic acid as a preservative;, dry residue 3.13.6 %, chloride content max. 0.4 %, total nitrogen 0.160.20 %, hydroxyproline content 0.120.15 %, C. content 0.91.1 %, sodium benzoate 0.150.20 %. Applications Biological properties are attributed to C. hydrolysates obtained by special procedures (R. Riemenschneider and W. H. Chik, Cosmet. Toiletries 94, No. 5, 61 [1979]; Textilbericht 62, No. 22, 6768 [1978]). C. hydrolysates are claimed to have skin care properties. According to various studies this is primarily due to the fact that C. improves the water retention capacity of the stratum corneum. E. E. Sabelmann gave a review of the biology, biotechnology and biocompatibility of C. (246 references) (Biocompat. Tissue Analogs 1, 27 [1985]; C. A. 103, 220658 [1985]). M. D. Bucevschi et al. describe the manufacture of C. derivatives esterified with low molecular weight aliphatic alcohols (Rom. RO 82.037 of 15. 4. 81/30. 6. 83; C. A. 101, 213039 [1984]). P. H. Cade published a survey of various C. derivatives (HAPPI, Household Pers. Prod. Ind. 21, No. 9, 50 [1984]; C. A. 101, 197906 [1984]). Dilute C. can form inactive complexes with active substances (Farmatsiya [Moscow] 33, No. 6, 17 [1984]; C. A. 102, 84335 [1985]). Manufacturing procedures for C. (M. D. Ranganayaki et al., Res. Ind. 33, 205 [1988]; C. A. 110, 101502 [1989]), M. Hata (Japan. Kokai Tokkyo Koho JP 03 11.100 of 6. 6. 89/18. 1. 91; C. A. 114, 214169 [1991]) and R. Armengol (SFW 117, 717 [1991]); procedure for extracting acetylated C. (Y. Suzuki, Japan Kokai Tokkyo Koho JP 02 62.815 of 30. 8. 88/2. 3. 90; C. A. 113, 120623 [1990]). R.-D. Petersen rightly states that C.s are not only auxiliary substances

405 but are also bioactive (Apoth.-J. 1990, No. 1, 6). N. Skalko and M. Cajkovac discuss the range of application of C. (Farm. Glas. 45, 1 [1989] [ser]; I. P. A. 26, 12505 [1989]), T. Miyata (Fragrance J. 18, No. 3, 70 [1990] [jap]; C. A. 113, 217734 [1990]), T. Miyata (Fragrance J. 18, No. 3, 180 [1990] [jap]; C. A. 112, 185531 [1990]), E. S. Lower (Parfm Kosmet. 72, 465 [1991]), J. Cotte and H. Dumas (J. Pharm. Belg. 46, 201 [1991]; C. A. 115, 119792 [1991]) and M. Chvapil and B. J. Snider (Report 1990, Order-Nr. AD-219945, 81 pp; Avail. NTIS From Gov. Report Announce Index [U.S.] 1990, 90 [14] para no. 037027; C. A. 114, 179904 [1991]) (manufacture of skin protective films). Compound delivery using rapidly dissolving C. films (WO 99/61047; Pharm. Ind. 62, 368 [2000]). Nano particles that are suitable for microencapsulation of drugs can be manufactured from C. (J. Pharm. Pharmacol. 35, 537 [1983]; I. P. A. 21, 8280 [1984]). According to F. A. Kinci et al. C. is also suited as a drug carrier, e. g. for tetracycline (Arch. Pharm. 317, 657 [1984]; I. P. A. 22, 3937 [1985]; C. A. 101, 136972 [1984]), L. P. Istranov et al. (Farmatsiya [Moscow] 33, No. 5, 76 [1984] [rus]; C. A. 102, 31963 [1985]). C. as a biomaterial for drug delivery (W. Friess, Eur J. Pharm. A. Biopharm. 45, 113 [1998]; I. P. A. 36, 3605724 [1999]). By cross-linking of purified C. with a glycosaminoglycan (chondroitin-6-sulfate) films are obtained which can be used as artificial skin (I. V. Yannas et al., Polymer. Mater. Sci. Eng. 57, 28 [1987]; C. A. 107, 205126 [1987]). According to S. D. Coapman et al. permeation of C. can be tested in vitro in hairless mouse skin (J. Soc. Cosmet. Chemists 39, No. 5, 275 [1988]; C. A. 110, 82267 [1989]). According to J. Petres deficiencies of the soft parts of the skin in certain places can be corrected by injecting C. (Kosmetik international 1990, No. 4, 117). The design and applications of a liposomal system for age defying skin care products that modulates epidermal cytokine production to selectively increase C. III, including in vitro and in vivo studies, are described (R. K. Chaudhuri et al., Cosmet. Toiletries 115, 53 [2000], I. P. A. 38, 3801297 [2001]). T. Miyata reports on application of C. and steloc (Shin Tanpakushhitsu Oyo Kagaku 679 [1996] [jap]; C. A. 128, 16309 [1998]). On medical application of C. (J. Guan and J. Wu, Junshi Yixue Kexueyuan Yuankan 21, 4, 305 [1997] [ch]; C. A. 128, 299396 [1998]). C. sponges and its hemostatic properties (J. Wu et al., Shengwu Yixue Gongchengxue Zashi 15, 1, 63 [1998], C. A. 129, 72177 [1998]). Structural analysis of C. sponge and its biological evaluation (J. Wu et al., Junshi Yixue Kezueyuan Yuankan 22, 281 [1998]; C. A. 133, 9538 [1999]). S. Trasciatti et al. report on in vitro effects of different formulations of bovine C. on cultured human skin (Biomaterials 19, 10, 897 [1998]; C. A. 129, 140598 [1998]). The effect of C. implant materials on wound healing (G. E. Romanos et al., Biol. Matrices Tissue Reconstr. 13 [1998]; C. A. 129, 293794 [1999]). The roles of keratin and C. in skin keratinization mechanisms (16 refs) (Y. Kitajima, Kobunshi 47, 746 [1998]; C. A. 130, 56947 [1999]). If C. is ground in a vibration mill at temperatures < 180 K. (35 min), a powder with a particle size of 210 g is obtained which swells well in water and gives a good ointment base (N. E. Segalova et al., Chimikofarmacevt. Z. 15, 96 [1981] [rus]; Zbl. Pharm. 121, 914 [1982]). A solubilization procedure for obtaining water-soluble C. from fresh calf skin which is suitable for the manufacture

Col
of cosmetic agents has been described by U. Grzegorzewska et al. (Riv. ital. Essence, Profumi etc. 62, 388 [1981]; I. P. A. 19, 3043 [1982]). Using 14C- or 125I labeled acid-soluble C. it can be demonstrated in rat skin that C. permeates the skin both from solutions and from creams (A. Huc et al., Parfums, Cosmt. Aromes 40, 87, 93 [1981]; C. A. 95, 225469 [1981]). The irritant action of e.g. shampoos can be markedly decreased by the addition of C. products (P. Morganti et al., Int. J. Cosmet. Sci. 5, 7 [1983]). Developmeent of artificial C. (S. St. Pierre and T. Brodniewicz, US 5,856,308, Pharm. Ind. 61, 8, 733 [1999]). Properties, modifications and applications (P. Peterkova and L. Lapcik Jr., Chem. Listy 94, 371 [2000] [cz]; C. A. 133, 63672 [2000]). Toxicology The CIR Panel studied the available results on the toxicity of C. hydrolysates and finally concluded that these products can be described as safe in the concentrations used in cosmetic agents (R. L. Elder, J. Am. Coll. Toxicol. 4, No. 5 [1985]; Toxicol. Abstr. 9, No. 4-2329 [1986]; C. A. 104, 74770 [1986]). Analytics According to C. Valenta and F. Gabor gel electrophoresis is suitable for quality assurance of C. products (Sci. Pharm. 60, 267 [1992]). References R. Fleischmajer, B. R. Olsen and K. Kuhn, Biology, Chemistry and Pathology of Collagen. New York Academy of Sciences, Vol. 460. New York, N. Y. 1985. Evaluation of collagen products for cosmetic application (Yong Peng et al., Int. J. Cosmet. Sci. 55, 327 [2004]). Comparative study of the physiological properties of collagen, gelatin and collagen hydrolysate as cosmetic materials (G. Y. Li et al., Int. J. Cosmet. Sci. 27 (2), 101 [2005]). Collagen CLR (CLR) Definition Native soluble collagen with nature-identical, undamaged structure. Available with collagen concentrations of 0.3 % and 1 %. INCI Soluble Collagen. Applications Emulsified, aqueous and aqueous-alcoholic skin regenerating products designed to counteract dry and help mature skin, and prevent the skin from damage caused by environmental influences, especially UV exposure. High potential to bind water, helps to promote skin hydration, accelerates skin soothing. Collagen hydrolysates (Cognis, Connock, Cosmetochem, Croda, Maybrook) Definition Water-soluble products obtained by gentle hydrolysis of collagenous proteins, which are usually offered as aqueous solutions. INCI Hydrolyzed Collagen, CAS 9015-54-7. Properties Aqueous solution of a collagen polypeptide, soluble in water, glycerol, propylene glycol and 50 % ethyl alcohol. Product data pH of a 10 % solution 6.06.5, relative density 1.121.14, solids min. 30 %, dry weight 14.5 %, salt content max. 3.0 %. Applications For the manufacture of skin and hair care agents (0.55 %), protective colloid in decolorizing and waving agents, for hair setting lotions, improves the properties of hair and its styling properties. N. Radulescu et al. describe the manufacture of a powdered C. which contains 9799 % collagen proteins, has a molecular weight of 500 000 to 600 000 and contains 57 % moisture. The

Man
0272 438 of 29. 8. 88; Manufact. Chemist 60, No. 8, 54 [1989]). Toxicology LD50 (rat) 300 mg/kg, oral LDLo (rat) 3000 mg/kg. According to E. Konrad et al. M. is well tolerated by the skin, causes no sensitization and is nontoxic. p-Mandelic acid (Merck) Definition `d,l-Mandelic acid. Mandioca starch Definition `Tapioca. Mango seed fat Definition Obtained by extracting freshly collected seeds of the mango fruit (Mangifera indica) (923 % of the fruit) with hexane. Product data The crude fat and the refined fat (values in brackets) were analyzed: mp 38 (38), d30 0.901 (), nD40 1.4470 (1.4570), titer 51, Bellier value 38.5 (), moisture 0.08 % (), AV 6.0 (0,3), SV 191 (190), IV 50 (50), unsaponifiable matter 1.5 (0.7 %) (B. L. Narasimha et al., Cosmet. Toiletries 94, No. 1, 34 [1979]). The following fatty acid composition (%) was determined using GLC: palmitic- 8.6, stearic- 42.2, oleic- 45.8 and linoleic acid 3.4. The fat content of the seeds is 11 % on average. Another study was performed by W. van Pee et al. (Fette, Seifen, Anstrichmittel 83, 383 [1981]). The yellow fat, mp 3538 is very similar to `cocoa butter. The study had the following results: 32.744.0 % of the triglycerides and/or 43.753.4 % of all fatty acids are stearic or oleic acid. The remainder consisted of (%): palmitic- (6.77.0), linoleic- (3.66.9), arachic- (1.12.5) and linolenic acid (0.31.0). The triglycerides of the total of 9 M. types analyzed consist mainly of sn-1,3-disaturated-2-oleoyl- and sn-1(3)-saturated-2,3-1,2)-dioleyl glycerides. Applications M. is suitable for consumption and as a substitute for tallow and cocoa butter. References K. Bhattacharya and K. S. Shukla, Mango butter in cosmetic formulations (Cosmet. Toiletries 117, 65 [2002]). Manihot starch Definition `Tapioca. Manioca Definition Kassave or `Cassava; a Brazilian purgative plant (Manihot utilissima), whose tubers contain a lot of starch and are processed to flour suitable for consumption. Applications Starch may also be isolated from the tubers and may be used for food purposes or for the manufacture of e. g. tablets (binder). M. starch has good swelling properties and is therefore particularly suitable for the manufacture of tablets (C. Siregar et al., J. Pharm. Belg. 41, 139 [1986]; C. A. 105, 178343 [1986]). Toxicology According to a report, frequent consumption of M. (M. is an important foodstuff in Africa) prevents absorption of iodine in thyroid tissue thus inducing endemic goiter, cretinism and mental retardation. It is assumed that thiocyanates form from M. and may be responsible for the occurrence of hypothyroidism (Dtsch.

926 Apotheker-Ztg. 118, 1017 [1978]). Importance of M. for the economy and nutrition in Southeast Asia (J. H. Hohnholz and R. Schmid, Naturwiss. Rdsch. 35, 95 [1982]). Manna sugar Definition `Mannitol. Mannans Definition Polymannans. Polysaccharides of mannose (Hemicelluloses) frequently occurring in nature. They usually function as reserve carbohydrates of the plants and occur as skeletal substances. M. are the main components of the seed skin of the stone of date seeds. Using the yeast Hansenula holstii W. an M. is formed which, esterified with phosphoric acid, yields a phosphomannan (`Phosphomannan Y-2448) which may be used as an emulsifier, dispersing and suspending and/or thickening agent (hydrocolloid). M. is suitable as a coating agent for `activated charcoal. The granules produced may be used orally for detoxication of blood (O. Otsubo, japan. Kokai Tokkyo Koho 80 95.611 of 17. 1. 79/21. 7. 80; C. A. 94, 109352 [1981]). Sterilization of M. solutions is possible but should not exceed 1 h; for the conditions under which the solutions remain sterile during storage see (N. P. Elinov et al., Pharm. Chem. J. [USSR] 14, 272 [1981]; Internat. Pharm. Abstr. 21, No. 7-3912 [1984]). Manneotetrose Definition `Stachyose. Mannid esters Definition `Crill. Mannitan Laurate Definition INCI name for the monoester of lauric acid and the anhydrides manufactured from `mannitol; CAS 1341-12-4. Mannitol (Amresco, Cerestar, Merck, Roquette, SPI Pharma, Spectrum Chemical) Definition USP Mannitol, Ph Eur Mannitol, JP D-Mannitol, D-Mannitol injection, INCI Mannitol, INN mannitol, IUPAC/WHO D-mannitol, 1,2,3,4,5,6-Hexanehexol. Manna Sugar, Mannite, D-Mannitol, CAS 69-65-8, EINECS/ELINCS 200-711-8. M. is an isomer of `sorbitol. Empirical formula C6H14O6, mol wt 182.17. See formula, SEM pictures (100x, 1000x). Properties M. is a white, non-hygroscopic odorless, crystalline powder or free flowing granules with a taste as sweet as sucrose. It has a cooling sensation in the mouth. Moisture content < 0.3 %. True density d 1.514 g/cm3, pKa 13.5 (at 18), flash point > 180. Solubility 1 g in 5.5 g of water, 18 g of glycerol, 83 g of ethanol and 100g of 2-propanol, practically insoluble in ether, nD 1.333 (20),

927

Man
has significant effects on the properties of the tablets (Congress Int. Technol. Pharm. 31th ed. 1989, 4, 323; C. A. 112, 104759 [1990]). M. is particularly suitable for the manufacture of lozenges, sublingual and chewing tablets (L. Geryser, Ceskoslov. Farmac. 2, 74 [1970] [cz], Zentralbl. Pharm. 109, 1202 [1970]). Manufacture and control of M. infusion solutions (F. Kchel, Mitt. dtsch. pharmaz. Ges. 34, 153 [1964], A. Przyblka, Pharmaz. Ztg. 109, 1172 [1964]; Pharm. Ind. 27, 785 [1965] and B. Borkowski et al., Farm. Pol. 25, 657 [1969]; C. A. 72, 70608 [1970]). On heating of M. a clear, colorless, low-viscosity liquid is formed which is able to dissolve or disperse a number of drug substances (J. L. Knig, J. Pharm. Sci. 53, 188 [1964]; Pharmaz. Ztg. 109, 779 [1964]). Melted M. can also be added to other less valuable carbohydrates, e. g. cane sugar or lactose to form eutectic mixtures. These mixtures may also be added as solvents for active substances or as dry binders (M. W. Scott, A. P. 3 341 415 of 12. 2. 64/12. 9. 67; C. A. 67, 120196 [1967]). WarnerLambert Pharmaceutical Co. (A. P. 3 145 146 of 31. 10. 61/18. 8. 64; C. A. 61, 10543 [1964]) obtained a patent for an M. spray-dried according to a special procedure with a particle size distribution of 510 m which has significantly improved flow properties and is therefore primarily intended for use in the manufacture of tablets. M. is also used as a starting material for the manufacture of polyoxyethylated emulsifiers. The foaming properties of soaps are improved by addition of 2 % M. The chromosomal aberrations induced in apical meristem cells of the Welsh onion e. g. by exposure to -radiation can be largely prevented by M. (0.001 %) (G. K. Ragimowa et al., Izv. Akad. Nauk. Az. SSR. Ser. Biol. Nauk. 3, 13 [1986] [rus]; C. A. 106, 209260 [1987]). Properties and use in medicine (S. E. Warren and R. C. Blantz, Arch. Intern. Med. 141, 493 [1981]; Toxicol. Abstr. 5, No. 2-1097 [1982]; Internat. Pharm. Abstr. 18, No. 14-3391 [1981], 36 references). M. is well-proven in the treatment of severe and painful osteoarthritis (U. Ambanelli et al., Current Therap. Rev. 30, 85 [1981]). Toxicology M. is a foodstuff and poses no significant hazard. Ingestion of amounts above 10/20 g per dose and 30/50 g per day can give a laxative effect. In tests for mutagenicity M. Ishidate jr. et al. found no positive action for M. either in the Ames or in the chromosome test (Food, Chem. Toxicol. 22, 623 [1984]). Occurrence of acute lung edemas after administration of M. (E. Hartmenn et al., Ann. Pediatr. 28, 209 [1981]; Toxicol. Abstr. 4, No. 10-8513 [1981]). Intoxication following infusion with M. (New. Med. J. Aust. 2, 151 [1981]; Internat. Pharm. Abstr. 19, No. 4-3095 [1982]), H. F. Borges (Arch. intern. Med. 142, 63 [1982]; Internat. Pharm. Abstr. 20, No. 2-0729 [1983]) and P. W. Gutschenritter et al. (Wiss. med. J. 84, No. 5, 16 [1985]; Toxicol. Abstr. 8, No. 8-4615 [1985]). High dose M. infusions may cause acute renal damage (G. M. Rabetoy et al., Ann. Pharmacother. 27, 25 [1993]; Internat. Pharm. Abstr. 30, No. 14-8335 [1993]). Analytics Determination of M. (U. Busser and W. Rosenberg, Krankenhauspharmazie 1, No. 9, 10 [1980]; Internat. Pharm. Abstr. 18, No. 3-0669 [1981]). Spectrophotometric method for the determination of M. (C. H. Blomquist, J. Clin. Chem. Clin. Biochem. 19, 139 [1981]). HPLC method for the determination of M., sorbitol and xylitol in e. g. chewing gum and similar preparations (E. C. Samarco et al., J. Assoc. Offic. Anal. Chem.

mp 167, flash point > 150, heat of solution 120.9 g/J, heat of combustion 16.57 kJ/g, []D25 (10 % water solution) 0,40. M. is stable, if stored in a dry form or as a sterile solution. In solution, M. is neither attacked by acids or alkalis in the cold, nor (in the absence of catalysts) by atmospheric oxygen. In the absence of mineral acids, bases and mineral salts M. can be heated to 250 without decomposition. M. is able to bind metal ions, such as Fe-, Cu-, Al-, Mo-, Co-, Ni-, Pb-, Bi- and other ions by complexing, primarily in alkaline solutions (F. Kchel, Mitt. Dtsch. Pharmaz. Ges. 34, 153 [1964], G. Floret and M. M. Massa, Ann. pharmac. fran. 24, 201 [1966]; Pharmaz. Zentralhalle 106, 315 [1967]). M. shows an osmotic diuretic activity accelerating renal excretion of drugs. Applications M. is a reduced caloric and non-cariogenic sweetener. It is suitable for water sensitive applications. For solid dosage forms it is used as sweetening agent, as plasticizer for gelatin capsules, as filler/binder in tablet, capsule and powder formulations, for direct compression and for lyophilized preparations. A pyrogen free and endotoxin controlled quality is available for parenteral nutrition, dialysis and serum applications. B. Debord et al. studied the properties of the various polymorphic forms of M. for their suitability as tablet binder. The granulated -form of M. was particularly suitable for direct compression (Drug Dev. Ind. Pharm. 13, 1519 [1988]; Internat. Pharm. Abstr. 25, No. 15-7756 [1988]). J. van Dijk and H. Bijl studied the physical properties of various Ms. and their effect on the disintegration of tablets. The particle size distribution of the M. samples

Pha

1100 Definition Trade name for pharmaceutical grade lanolin, manufactured to GMP standards. Conforms to Ph Eur monograph for wool fat. Pharmasolve (ISP) Definition Trade name for N-methyl-2-pyrrollidone cGMP grade. Product data Liquid, boiling point 202, specific density (25) 1.027, viscosity (25) 1.65 mPas. Applications Broad spectrum drug solubilizer. Increases solubility, rate of solubilization and solution stabiliy of drugs in aqueous solution. Pharmatose grades (DMV) Definition Milled, sieved and spray-dried types of `lactose. Lactose is a disaccharide, and normally available as monohydrate. 4-(-D-Galactopyranosido)-D-glucopyranose, 1-()-galactosido-(1-5)-4-glucose. Lactobiose, Milk sugar, Saccharum Lactis. Ph Eur, USP/NF, JP. CAS 63-42-3. Empirical formula C12H22O11 1 H2O. Mol wt 342.30. Structural formula see `Lactose. Properties White, water soluble powders with a slightly sweet taste. No odor. Product data See tables. Applications The sieved types of lactose are used as filler in hard-gelatin capsules, flow-improving agent and diluent in direct compression formulations. Milled types are used as filler in wet granulation processes. The DCL types are showing, based on the manufacturing procedures, a very good flow and tablettability. Mainly used for tablets, capsules and sachets. The two products DCL 21 and DCL 40 are in addition applied in chewables, multivitamin tablets, DCL 40 also for high dosage forms, because they form tablets with a high tablet strength. Single products 6 sieved types: P. M 50, M 80, M 90, M 100, M 110, and M 125. 4 milled types: P. M 150, M 200, M 350, and M 450. P. DCL 11: spray-dried lactose, DCL 15: granulated lactose, DCL 21: anhydrous lactose (-form of anhydrous lactose is mainly present), DCL 40: compound lactose (95 % anhydrous lactose and 5 % lactitol).
Pharmatose BET surface area (m2/g) Bulk density (g/l) Bulk density (tapped, g/l) < 45 m < 63 m < 100 m < 150 m < 250 m < 315 m M 150 0.45 580 890 M 200 0.50 550 850 M 350 0.60 500 820 M 450 1.0 470 770

Pharmacoat (Shin-Etsu) Definition Hydroxypropyl methyl cellulose (HPMC), cellulose, 2-hydroxypropyl methyl ether. INCI Hydroxypropyl Methylcellulose, CAS 9004-65-3. USP/NF, Ph Eur.

Properties White to light-yellow colored fibrous or granular powders. Pharmacoat swells in water, forming a clear to opalescent, viscous, colloidal solution. Insoluble in absolute ethanol, ether, or chloroform. Spec. gravity 1.261.31, apparent density 0.50.7 g/ml (tapped), average particle size 5070 m. Product data See table.
Pharmacoat pH Apparent viscosity Loss on drying Residue on ignition Arsenic Heavy metals Chlorides Methoxyl content Hydroxypropyl content 2.43.6 603 606 4.67.2 615 12.018.0 904 3.24.8

all types 5.58.0

not more than 5 % not more than 1 % (EP) not more than 1.5 % (USP) below 3 ppm below 10 ppm not more than 0.5 % 28.0 30.0 % 7.0 12.0 % 19.0 24.0 % 4.0 12.0 %

Applications Binder in tablet manufacture and tablet coating (aqueous or organic) for taste-masking, improvement of hardness, sub-coating for sugarcoating and enteric coating. Toxicology Toxicity ( and Wistar rats) LD50 > 15 g/ kg, subacute toxicity ( and rats, Wistar strain, oral application of 1.25, 2.50 and 5.0 g/kg for 30 days) no changes (body weight, food ingestion, organic weight, analysis of blood and urine, histopathological tests), chronic toxicity ( and Wistar rats, administration of 1.25, 2.50 and 5.00 g/kg for 6 months) no changes. Metabolism: Wistar rats, oral administration of 14C-P; 100 mg/kg, oral. Within 72 h 0.39 % in the urine and 98.92 % 14 C-P. in the feces. Analytics Analytical methods described in the pharmacopoeias. Pharmalan (Croda)

Particle size distribution max. 50 % 5065 % min. 60 % min. 90 % 100 % min. 98 % 100 %

min. 70 % min. 90 % min. 96 % min. 85 % min. 96 % 100 % min. 96 % 99100 %

1101
Pharmatose Angle of repose Bulk density (g/l) Bulk density (tapped, g/l) Particle size distribution (%) < 45 m < 63 m < 100 m < 150 m < 200 m < 250 m < 315 m < 400 m max. 20 min. 80 max. 20 7090 min. 95 max. 10 1530 5590 100 max. 15 6080 min. 99 max. 20 3060 7590 100 M 50 36 725 825 M 80 38 760 910 M 90 39 760 910 M 100 39 750 900 M 110 40 730 890

Pha
M 125 44 680 870 max. 40 4070 min. 90 100

Pharmatose 325 M (DMV) Definition -Lactose monohydrate for inhalation, Ph Eur, USP/NF, JP. Properties -Lactose monohydrate designed for the formulation of dry powder inhalations, selected particle size range by sieving. Applications Carrier in dry powder inhalation systems. Pharmatose DCL11 (DMV) Definition Spray dried lactose, Ph Eur, USP/NF, JP. Properties Agglomerated pure -lactose monohydrate, showing good compression and flow properties. See SEM picture. Product data Particle size range: 1030 % < 75 m, 40 70 % < 150 m, 90100 % < 355 m, 100 % < 500 m. Applications Filler/binder for direct compression, carrier for capsule and sachet filling. Pharmatose DCL21 (DMV) Definition Anhydrous lactose containing 80 % -lactose, Ph Eur, USP/NF, JP.

Properties Spherical particles of nearly uniform size, excellent flowability and compressibility. See SEM picture. Product data Particle size range: < 15 % < 45 m, 3060 % < 100 m, 98100 % < 250 m. Applications Filler/binder in direct compression, carrier for interactive mixtures. Pharmatose DCL15 (DMV) Definition Granulated -lactose monohydrate, Ph Eur, USP/NF, JP.

Pol
Polyethylene glycol(500)nonyl phenyl ether carboxylic acid Definition `Nonoxynol-(10)-Carboxylic Acid. Polyethylene glycol(300)nonyl phenyl ether phosphate Definition `Nonoxynol-6 Phosphate.

1146 trian Pharmacopoeia, which is too hard, especially in the cold. K. E. Schulte and M. A. Kassem (Pharm. Acta Helvetiae 39, 383 [1964]) recommend a P. of polyethylene glycol 400, 1500 and 4000 (57,5:20:22,5). To improve the water absorbency of a P. which consists of equal parts of P. 4000 and P. 400 5 % cetyl alcohol may be added. According to W. Chandranondnaiwinit and E. B. Sommers even better results are achieved, if 0.5 % anhydrous, non-neutralized `Carbopol 934 is added (J. Pharm. Sci. 55, 1221 [1966]). Water absorbency is increased to 48 % by this additive. `Lanogen 1500. References W. Kern, O. Salzmann, H. Rath and Fr. Salzer, Pharm. Ind. 18, 3 (1956). Polyethylene glycol(100)oleamide Definition The polyethylene glycol-100-amide of oleic acid (I), n = 2. INCI PEG-2 Oleamide, CAS 20429-33-8.

Polyethylene glycol(n)nonyl phenyl ether phosphate, sodium salt Definition Sodium salts of complex mixtures of esters of phosphoric acid and `Nonoxynol. INCI Sodium Nonoxynol-n Phosphate, CAS 9014-90-8. Polyethylene glycol(16)octyl phenyl ether (Dow Chemical) Definition PEG-16 octyl phenyl ether, polyoxyethylene(16)octyl phenyl ether, INCI Octoxynol-16, CAS 9004-87-9, 9036-19-5, an ethoxylated alkyl phenol, C8H17C6H4(OCH2CH2)nOH, n has an average value of 16. The product is commercially available under the name Triton X-165. Polyethylene glycol(30)octyl phenyl ether (Dow Chemical, Nikko) Definition PEG-30 octyl phenyl ether, polyoxyethylene(30)octyl phenyl ether, INCI Octoxynol-30, CAS 9004-87-9, 9036-19-5, an ethoxylated alkyl phenol, C8H17C6H4(OCH2CH2)nOH, n has an average value of 30. The product is commercially available under the name Triton X-305. Polyethylene glycol(70)octyl phenyl ether (Dow Chemical) Definition PEG-70 octyl phenyl ether, polyoxyethylene(70)octyl phenyl ether, INCI Octoxynol-16, CAS 9004-87-9, 9036-19-5, an ethoxylated alkyl phenol, C8H17C6H4(OCH2CH2)nOH, n has an average value of 16. The product is commercially available under the name Triton X-705. Polyethylene glycol(400)octyl phenyl ether (Dow Chemical) Definition PEG-8 octyl phenyl ether, polyoxyethylene(8)octyl phenyl ether, INCI Octoxynol-8, CAS 900487-9, 9036-19-5, an ethoxylated alkyl phenol, C8H17 C6H4(OCH2CH2)nOH, n has an average value of 8. The product is commercially available under the name Triton X-114. Polyethylene glycol ointment Definition USP, Macrogol Ointment BP, Unguentum Polyethylenglycoli. There are various possible formulations. One such consists of equal parts of polyethylene glycol 300 and polyethylene glycol 1500 which are mixed with heating and stirred until they have cooled. To obtain a uniform, readily spreadable ointment the amounts of the polyethylene glycols may be varied by up to 10 % of their weight. This formulation is more suitable than P. manufactured in accordance with USP or the Aus-

Polyethylene glycol(100)oleammonium chloride (Akzo Nobel) Definition A quaternary ammonium salt (I), n is approx. 2. INCI PEG-2 Oleammonium Chloride. Ethoquad O/ 12H (`Ethoquad).

Polyethylene glycol(15)oleate Definition A polyethylene glycol ester of oleic acid, INCI PEG-15 Oleate, CAS 9004-96-0. Polyethylene glycol(16)oleyl ether (Amerchol) Definition PEG 16 oleyl ether, polyoxyethylene(16)oleyl ether, INCI Oleth-16; is the polyethylene glycol ether of oleyl alcohol, CH3(CH2)7CH = CH(CH2)7CH2(OCH2 CH2)nOH, n has a value of approx. 16. The product is commercially available under the name `Solulan 16. `Oleth-n. Polyethylene glycol(1-4)oleyl ether sulfate, sodium salt Definition The sodium salt of the sulfate ester of the polyethylene glycol ether of oleyl alcohol, INCI Sodium Oleth Sulfate, CAS 42415-80-5. Polyethylene Glycol(500)-Olive Oil Glycerides Definition INCI name for a polyethylene glycol(500)-derivative of the mono- and diglycerides of olive oil. Polyethylene glycol(12)palm kernel oil glycerides Definition `Crovol PK 40.

1147 Polyethylene glycol(45)palm kernel oil glycerides Definition `Crovol PK 70. Polyethylene glycol(1000)-palm oil (hydrogenated) Definition `Palm oil, hydrogenated and ethoxylated. Polyethylene glycol-paraffin oil gels Definition `Polyethylene glycols. Polyethylene glycol-200-pelargonate Definition A nonionic biodegradable liquid containing 100 % active substance which is used as an emulsifier and solubilizer, and as a skin and/or hair conditioner in cosmetic preparations. Polyethylene glycol(500)propylene glycol Definition Polyoxyethylene(10)propylene glycol, INCI PEG-10 propylene glycol, a polyethylene glycol ether of propylene glycol (I), x + y has an average value of 10.

Pol

Polyethylene glycol(1000)sorbitol ether Definition Sorbeth-20, RD 977058-26-6, polyoxyethylene(20)sorbitol ether, PEG-20 sorbitol ether, Ethosperse SL-20, an ethoxylated ether of sorbitol, containing approx. 20 mol EO were reacted. Polyethylene glycol-sorbitol-macromolecules Definition If polyethylene glycol (mol wt 200600) is heated with sorbitol in the presence of water polymerization ensues. The water-soluble polymers obtained were studied by N. M. Mursi et al. (Pharm. Ind. 39, 918 [1977]); they are reported to be suitable as a base for the manufacture of pharmaceutical preparations. Polyethylene glycol(3)stearate (Goldschmidt) Definition A polyethylene glycol ester of stearic acid (I), n has an average value of 3. The product is commercially available e. g. under the name Tegin D 1102. INCI PEG3 Stearate, CAS 9004-99-3, 10233-24-6.

Polyethylene Glycol Resin Definition INCI name for a polymer of ethylene oxide, H(OCH2CH2)nOH. The mol wt ranges between 1 105 and 5 106. Properties P. resins are white, granular, freely flowing powders with a characteristic odor. They can be dispersed in water. Product data pH value of a 5 % aqueous dispersion approx. 10.0, viscosity of a 5 % aqueous dispersion 550 900 mPas, loss on drying max. 1.0, ash content max. 0.8 %. Polyethylene glycol sorbitan (mono)oleate (Uniqema) Properties A light yellow to brownish yellow, oily liquid with a faint odor and a bitter taste. Product data D 1.082, viscosity (20) 680.38 cP, pH 6.25, AV 0.87, SV 49.69, OHV 72.05, IV 21.21, loss on drying 2.4 %, combustion residue 0.6 %. Applications Solubilizer and nonionic emulsifier. Toxicology Although a report of the CTFA, published in January 1992, emphasizes that P. has not, so far, been shown to be carcinogenic, or dangerous, the NTP (National Toxicological Program) has called for further toxicological testing of P. to supplement the available data. Analytics Detection of P. and other esters in foodstuffs (TLC on silica gel) (J. M. Murphy and C. C. Scott, Analyst 94, 481 [1969]; Zbl. Pharm. 109, 409 [1970]). Polyethylene glycol(3)sorbitan stearate Definition An ethoxylated sorbitan monoester of stearic acid; it contains about 3 mol of ethylene oxide; INCI PEG-3 Sorbitan Stearate, CAS 9005-67-8.

Polyethylene glycol(120)stearate Definition A polyethylene glycol ether of stearic acid, INCI PEG-120 Stearate, CAS 9004-99-3. Polyethylene glycol-400-stearate Definition `Cremophor S 9. Polyethylene glycol-x stearates Definition The Final report on the safety assessment has been published in the USA for P. (x = 2, 6, 8, 12, 20, 32, 40, 50, 100 and 150) (K. H. Beyer jr. et al., J. Amer. Coll. Toxicol. 2, 17 [1983] [42 references]; C. A. 100, 91095 [1984]). P. are described as safe cosmetic ingredients. Polyethylene glycol-1000-stearic acid ester Definition `Neutronyx 332. Polyethylene glycol(100)stearmonium chloride (Akzo Nobel) Definition A quaternary ammonium salt (I), x + y is approx. 2. INCI PEG-2-Stearmoniumchloride, CAS 6068787-8. Ethoquad 18/12 (`Ethoquad).

Polyethylene glycol(5)stearyl ammonium lactate (Clariant)

Ten

1442 Applications Undiluted T. should not be brought into contact with skin; they improve the surface activity of other surface-active agents and particularly the antiseptic properties of acid, antiseptic preparations and the action of penicillin. The anionic types 4, 7 and 08 are used for destroying emulsions in the manufacture of penicillin, types 4 to 7 form soluble complexes with streptomycin and similar antibiotics in organic solvents and are hence suitable for isolating streptomycin etc. In bactericidal preparations the nonionic types XD and NPX enhance dispersion of the ingredients. Solutions of amine soap shampoos are improved by addition of T. type NPX or XD; they can be rinsed off more easily. Hair conditioners are improved by addition of T. type XD (proposed formulation: Ucon Fluid LB-1715 50.0, polyethylene glycol 1540-monostearate 3.75, T. type XD 1.25 and water 45.0). Single products 1. Nonionic types (100 % active substance, unless otherwise specified). NP-14. Nonyl polyethylene glycol ether with 4 molecules EO, an almost colorless liquid, solubility in water < 0.01 %, readily soluble in fats and solvents, pH (in 0.1 % aqueous solution) 6.2, freezing point 40, dA 1.031, viscosity 448 cSt (20), LD50 (rat, oral) 4.29 ml/kg, mild skin irritation (rabbit), reaction on the rabbit eye after application of a 15 % solution. NP-27. Nonyl phenyl polyethylene glycol ether with 7 molecules EO, an almost colorless liquid, solubility in water 20 %, soluble in fats and various solvents, dispersible in paraffin oil, pH 6.1, freezing point 5 to 7, dA 1.055, viscosity 338 cSt (20), LD50 (rat, oral) 3.67 ml/kg, no skin irritation (rabbits), reaction on the rabbit eye after application of a 15 % solution. TP-9. Nonyl phenyl polyethylene glycol ether with 9 molecules EO, colorless liquid, soluble in water, sparingly soluble in fats, insoluble in paraffin oil, soluble in various solvents, pH 5.2, freezing point 6, dA 1.057, viscosity 318 cSt (20), LD50 (rat, oral) 2.6 ml/kg, mild skin irritation (rabbit), reaction on the rabit eye after application of a 5 % solution. NPX. Nonyl phenyl polyethylene glycol ether with 10.5 molecules EO, practically colorless liquid, soluble in water, sparingly soluble in fats, soluble in various solvents, insoluble in paraffin oil, pH 7.5, freezing point 57, dA 1.063, viscosity 327 cSt (20), LD50 (rat, oral) 1.31 g/kg, mild skin irritation (rabbit), reaction on the rabbit eye following application of solutions > 5 %. NP-35. Nonyl phenyl polyethylene glycol ether with 15 mol EO, a semisolid mass, soluble in water and various solvents, sparingly soluble in fats, insoluble in mineral oil, pH 6.1, sp 2527, dP 1.065, viscosity 144 cSt (38), LD50 (rat, oral) 4.00 g/kg, no skin irritation (rabbit), reaction on the rabbit eye after application of 100 % substance. NP-40. Nonyl phenyl polyethylene glycol ether with 20 molecules EO, a white solid, soluble in water and various solvents, insoluble in fats and mineral oil, pH 6.6, sp 36 38, dP 1.077, viscosity 55 cSt (65), LD50 (rat, oral) 15.9 g/kg, no skin irritation (rabbit), reaction on the rabbit eye after application of 100 % substance. TMN. Trimethyl nonyl ether of polyethylene glycol with 6 mol EO, a pale yellow liquid, 90 % active substance, soluble in water, pH 6.8, sp 1517, dA 1.024, viscosity 105 cSt (20), LD50 (rat, oral) 3.26 g/kg, no skin irritation

T. HB7, sodium alkyl (C913) sulfate, activity 40 %, fluid liquid. T. ALS70, ammonium lauryl (C1214) sulfate, activity 70 %, viscous gel. T. ALS25, ammonium lauryl (C1214) sulfate, activity 25 %, fluid liquid. Dried products: T. 12P, sodium lauryl (C12) sulfate, activity 94 %, fine powder. T. USP94, sodium lauryl (C1214) sulfate, activity 94 %, fine powder. T. USP97, sodium lauryl (C1214) sulfate, activity 97 %, fine powder. T. A97, sodium lauryl (C1214) sulfate, activity 90 %, needles. T. A795 S, sodium lauryl (C1214) sulfate, activity 94 %, needles. T. PCL 94, sodium lauryl (C1218) sulfate, activity 93 %, fine powder. T. ACL79, sodium lauryl (C1218) sulfate, activity 90 %, needles. T. CO A795, sodium coco (C1218) sulfate, activity 93 %, needles. T. SPKA795P, sodium/potassium lauryl (C1214) sulfate, activity 93 %, needles. T. A13-15, sodium tridecyl (C1315) sulfate, activity 85 %, needles. Tensowax grades (Tensachem) Definition Trade name for waxes. Applications Waxes for toiletries, hair care and skin care products. Single products T. CSA P, cetostearyl alcohol non-ionic wax, activity 100 %, pellets. T. N21 P, blend of cetostearyl alcohol and non-ionic emulsifier, activity 100 %, pellets. T. N200 P, blend of cetostearyl alcohol and non-ionic emulsifier, activity 100 %, pellets. T. SXBP P, blend of cetostearyl alcohol and anionic emulsifier, activity 100 %, pellets. TEPD Definition Abbreviation for `transepidermal water loss (Perspiratio insensibilis). Teratogenicity Definition A substance has teratogenic effects, if it causes abnormalities in an embryo because of treatment of the mother animal with the substance during pregnancy. Terephthalic acid ester Definition The para (1,4) isomer of `phthalic acid dialkyl ester. Tergitol (Dow Chemical, Union Carbide) Definition Trade name for various anionic and non-ionic surface-active substances.

1443 (rabbit), reaction on the rabbit eye after application of a 1 % solution. 12-P-12. A nonionic dodecyl phenol ethylene oxide condensate, an all purpose cleaning and wetting agent with good dispersing and emulsifying properties, turbidity point (0.5 % aqueous solution) 6065, compatible with soaps, anionic, cationic and nonionic emulsifiers. XD. Polyethylene glycol ether, soft, semisolid mass, soluble in water and various solvents, insoluble in fats and mineral oil, pH 6.0, sp 2838, dP 1.053, viscosity 428 cSt (38), LD50 (rat, oral) 5.66 g/kg, no skin irritation (rabbit), reaction on the rabbit eye after application of 100 % substance. XH. Polyalkylene glycol ether, odorless solid, soluble in water, pH 6.0, sp 3640, dO 1.0344, viscosity 325 cSt (38), LD50 (rat, oral) 22.4 g/kg (25 % aqueous solution), mild skin irritation (rabbit), reaction on the rabbit eye after application of an aqueous 25 % solution. 2. Anionic types 7. 25 % aqueous solution of sodium heptadecyl sulfate, C4H9CH(C2H5)C2H3(SO4Na)C2H4CH(C2H5)2, colorless liquid, pH 5.3, dA 1.046, LD50 (rat, oral) 5.66 ml/kg, severe skin irritation (rabbit), reaction on the rabbit eye after application of a 5 % solution. P-28. 25 % aqueous solution of sodium di(2-ethylhexyl)phosphate, [C4H9CH(C2H5)CH2 ]2 NaPO4, brown liquid, pH 6.7, dA 1.034, LD50 (rat, oral) 7.72 ml/kg, severe skin irritation (rabbit), reaction on the rabbbit eye after application of a 5 % solution. 4. 25 % aqueous solution of sodium tetradecyl sulfate, C4H9CH(C2H5)C2H4CH(SO4Na) CH2 CH(CH3)2, practically colorless liquid, pH 8.5, dA 1.056, LD50 (rat, oral) 4.95 ml/kg, severe skin irritation (rabbit), reaction on the rabbit eye after application of a 5 % solution. 08. 38 % aqueous solution of sodium-2-ethyl hexyl sulfate, C4H9CH(C2H5)CH2-SO4 Na, colorless liquid, pH 7.3, dA 1.144, LD50 (rat, oral) 10.32 ml/kg, severe skin irritation (rabbit), reaction on the rabbit eye after application of 0.005 ml of the 100 % substance. Tergitol S series (Dow Chemical, Union Carbide) Definition A group of surface-active substances obtained from straight-chain secondary alcohols usually containing 1115 C-atoms and manufactured from petrol hydrocarbons by ethoxylation and, in some cases, sulfation. In the product T. nonionic 15-S-9 e. g. the number 15 indicates that the secondary alcohol contains 1115 carbon atoms, while the number 9 indicates the number of mol EO (x). The anionic product T. 15-S-3 A is manufactured from a secondary alcohol which contains 1115 carbon atoms, x is 3 and the final letter indicates that M is the ammonium salt. All products are readily biodegradable. Single products (a) Nonionic products (100 % active substance): T. 15-S-3, mol wt 332, turbidity point (in 1 % aqueous solution) indeterminable, sp 30, apparent density (d) 0.924, viscosity (20) 37 cSt, HLB 9.0, flash point 370, insoluble in water (25). T. 15-S-5, mol wt 420, turbidity point indeterminable, sp 15, apparent density (d.) 0.970, viscosity (20) 51 cSt, flash point 410, soluble in water.

Tet

T. 15-S-7, mol wt 508, turbidity point 37, sp 7, apparent density (d) 0.994, viscosity (20) 67 cSt, HLB 12.8, flash point 440, soluble in water, LD50 (rat, oral) 3.25 ml/kg, cutaneous toxicity (LD50, rabbit skin) 3.18 mg/kg, moderate irritation is observed on rabbit skin, serious irritation on the rabbit eye. T. 15-S-9, mol wt 596, turbidity point 60, sp 13, apparent density (d) 1.06, viscosity (20) 86 cSt, HLB 13, flash point 470, soluble in water, LD50 (rat, oral) 2.38 ml/kg, cutaneous toxicity (LD50, rabbit skin) 2.00 ml/kg, mild irritation is observed on rabbit skin but serious irritation on the rabbit eye. T. 15-S-12, mol wt 728, turbidity point 90, sp 17, apparent density (d) 1.023, viscosity (20) 120 cSt, HLB 15.0, flash point 460, soluble in water, LD50 (rat, oral) 3.36 ml/kg, cutaneous toxicity (LD50, rabbit skin) 4.00 ml/kg, only mild irritation is observed on rabbit skin but serious irritation on the rabbit eye. (b) Anionic products T. 15-S-3A, mol wt 435. 60 % active substance, sp 36, apparent density (dA) 1.039, viscosity (20) 43 cSt, flash point 195, soluble in water, LD50 (rat, oral) 17.2 ml/kg, cutaneous toxicity (LD50, rabbit skin) > 10 ml/kg, only mild reactions are observed on rabbit skin and moderate reactions on the rabbit eye. T. 15-S-3S, mol wt 440. 60 % active substance, sp 45, apparent density (d) 1.057, viscosity (20) 49 cSt, flash point 172, soluble in water, LD50 (rat, oral) 3.25 ml/kg, cutaneous toxicity (LD50, rabbit skin) 2.83 ml/kg. Serious irritation is observed both on rabbit skin and on the rabbit eye. The products T.15-S-9 and T. 15-S-3A were tested in a 10 % concentration for skin tolerance in 50 individuals. None of the products caused irritation or sensitization. Terra sigillata Definition Lemnian earth, seal earth, Siegelerde. An old name for `bolus, an `aluminum silicate. According to P. H. Graepel S. was used in the middle age almost as a cure-all (pta in der prakt. Pharm. 9, 297 [1980]) and as an antidote. Terra silicea Definition `Kieselguhr. Tetrabromo-o-cresol (Acros) Definition 2-Methyl-3,4,5,6-tetrabromophenol, (I), CAS 576-55-6, C7H4OBr4, mol wt 423.8. Properties Light beige, practically odorless, crystalline powder, mp 205208, soluble in acetone, ethyl alcohol, ethylene chloride, chloroform and toluene, soluble in dilute bases, insoluble in water, content min. 98.5 %. Applications T. is an antimicrobial agent with good inhibiting effects on Gram-positive bacteria. The minimal inhibitory concentration against Staphylococcus aureus, S. epidermidis, Streptococcus Aronson, S. pyogenes and