Академический Документы
Профессиональный Документы
Культура Документы
56.150-E6
(Supersedes 56.150-E5)
Page 1 of 2
December 2007
BENECEL products are supplied as white to off-white, free flowing powders. Controlled release (CR) grades
have a fine, narrow particle size distribution that is optimized for hydrophilic matrix tablets.
Grades
Nominal
Substitution Type Benecel Grade European Pharmacopoeia Application
Viscosity (mPas)*
A15 PH 15 Rheology control
Methylcellulose A15C PH 1,750 Rheology control
Rheology control
A4M PH 3,600
Bulk laxative
Tablet binder
E15 PH 15
Coating film former
Tablet binder
E50 PH 50
Coating film former
2910 Rheology control
E4M PH
3,600 Controlled release matrix
E4M PH CR Controlled release matrix
E10M PH
10,000 Controlled release matrix
E10M PH CR
K100LV PH
100 Controlled release matrix
K100LV PH CR
K4M PH Rheology control
3,600
K4M PH CR Controlled release matrix
Rheology control
K15M PH
18,000 Controlled release matrix
K15M PH CR Controlled release matrix
2208
Rheology control
K35M PH
35,000 Controlled release matrix
K35M PH CR Controlled release matrix
K100M PH
100,000 Controlled release matrix
K100M PH CR
K200M PH
200,000 Controlled release matrix
K200M PH CR
* Viscosities with a value below 600 mPas have been measured with a Ubbelohde viscosity meter
Viscosities with a value above 600 mPas have been measured with a Brookfield viscosity meter
Hercules does not recommend any use of its products that would violate any patent or other rights.
Aqualon, a Business Unit of Hercules Incorporated
Rijswijk/NL, Düsseldorf/D, Castelmaggiore (BO)/I, Tarragona/E,
Prague/Cz, Warsaw/PL, Moscow/R
www.aqualon.com
56.150-E6
Page 1 of 2
Specifications
Sulphated ash 1.5 % max
Loss on drying 5.0 % max
Heavy metals 10 ppm max
pH in solution 5.0 – 8.0
Particle size, laser Dv90 (CR grades only) 170 – 250 µm
Regulatory Status
All BENECEL® products labeled with the PH suffix are compliant with the monograph requirements of the
current editions of the United States Pharmacopeia and the European Pharmacopoeia,
BENECEL products are non-perishable. It is recommended to use the product in rotation on a first-in first-out
basis. The product should be stored under dry and clean conditions in its original packing and away from heat.
The product is hygroscopic. The packaging is selected in a way to avoid ingress of moisture, but the water
content of the packed product will/may increase if not stored dry.
Product Safety
Please read and understand the Safety Data Sheet (SDS) before using this product,