QUALITY CONTROL DEPARTMENT

RAW MATERIAL CERTIFICATE OF ANALYSIS

Name of Product: Sodium Lauryl Sulphate BP
Finished Product Specification No.: QC / RM / M1409 / 025 Review Period: 24 Months
Effective Date: 27.06.2019 Next Review Date: 27.06.2021
Vendor: S. Zhaveri Pharmakem Pvt. Ltd. Page 1 of 6
Manufacturer: Imi Fabi Llc, West Virginia

Sr.
TESTS TESTING PROCESS
No.
1 Appearance White or pale yellow, powder or crystals.
Freely soluble in water giving an opalescent solution, partly
2 Solubility
soluble in ethanol (96%).
First Identification A. Dissolve 0.1 g in 10 mL of water R and
shake. A copious foam is formed.
Second Identification B. To 0.1 mL of the solution prepared for
identification test A, add 0.1 mL of a 1 g/L solution
of methylene blue R and 2 mL of dilute sulfuric acid R. Add 2 mL
of methylene chloride R
and shake. An intense blue colour develops in the methylene
chloride layer.
Third Identification C. Mix about 10 mg with 10 mL of anhydrous
ethanol R. Heat to boiling on a water-bath,
3 Identification
shaking frequently. Filter immediately and evaporate the ethanol.
Dissolve the residue in 8
mL of water R, add 3 mL of dilute hydrochloric acid R, evaporate
the solution to half its
volume and allow to cool. Separate the congealed fatty alcohols by
filtration. To the filtrate
add 1 mL of barium chloride solution R1. A white, crystalline
precipitate is formed.
Forth Identification D. Ignite 0.5 g. The residue gives reaction (a)
of sodium (2.3.1).
Dissolve 1.0 g in 100 mL of carbon dioxide-free water R and add
0.1 mL of phenol red solution
4 Alkalinity R. Not more than 0.5 mL of 0.1 M hydrochloric acid is required to
change the colour of the
indicator.

PREPARED BY: CHECKED BY: APPROVED BY:

TARUN TANDEL SURAJ PATEL APEXA GOHIL

Chemist, Production Executive, Quality Control Executive, Quality Assurance
 QUALITY CONTROL DEPARTMENT
RAW MATERIAL CERTIFICATE OF ANALYSIS
Name of Product: Sodium Lauryl Sulphate BP
Finished Product Specification No.: QC / RM / M1409 / 025 Review Period: 24 Months
Effective Date: 27.06.2019 Next Review Date: 27.06.2021
Vendor: S. Zhaveri Pharmakem Pvt. Ltd. Page 2 of 6
Manufacturer: Imi Fabi Llc, West Virginia

Maximum 4 per cent.

Dissolve 10 g in 100 mL of water R, add 100 mL of ethanol (96 per
cent) R and shake the
solution with 3 quantities, each of 50 mL, of pentane R, adding
sodium chloride R, if
Non-esterified necessary, to promote separation of the 2 layers. Wash the
5
alcohols combined organic layers with 3
quantities, each of 50 mL, of water R, dry over anhydrous sodium
sulfate R, filter and
evaporate on a water-bath until the solvent has evaporated. Heat
the residue at 105 °C for 15
min and cool. The residue weighs a maximum of 0.4 g.
Dissolve 5.00 g in 50 mL of water R, add dilute nitric acid R
dropwise until the solution is
neutral to blue litmus paper R, add 2 mL of potassium chromate
6 Sodium chloride solution R and titrate with 0.1
M silver nitrate.
1 mL of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl.
Dissolve 0.500 g in 20 mL of water R, warming gently if
necessary, then add 1 mL of a 0.5 g/L
solution of dithizone R1 in acetone R. If the solution is red, add 1
M nitric acid , dropwise, until
the solution becomes bluish-green. Add 2.0 mL of dichloroacetic
7 Sodium sulfate acid solution R and 80 mL of
acetone R. Titrate with 0.01 M lead nitrate until a persistent violet-
red or orange-red colour is
obtained. Carry out a blank titration.
1 mL of 0.01 M lead nitrate is equivalent to 1.420 mg of Na2SO4.
8 Assay Dissolve 1.15 g in water R, warming if necessary, and dilute to
1000.0 mL with the same
solvent. To 20.0 mL of the solution add 15 mL of chloroform R

PREPARED BY: CHECKED BY: APPROVED BY:

TARUN TANDEL SURAJ PATEL APEXA GOHIL

Chemist, Production Executive, Quality Control Executive, Quality Assurance
 QUALITY CONTROL DEPARTMENT
RAW MATERIAL CERTIFICATE OF ANALYSIS
Name of Product: Sodium Lauryl Sulphate BP
Finished Product Specification No.: QC / RM / M1409 / 025 Review Period: 24 Months
Effective Date: 27.06.2019 Next Review Date: 27.06.2021
Vendor: S. Zhaveri Pharmakem Pvt. Ltd. Page 3 of 6
Manufacturer: Imi Fabi Llc, West Virginia

and 10 mL of dimidium
bromide-sulfan blue mixed solution R. Titrate with 0.004 M
benzethonium chloride, shaking
vigorously and allowing the layers to separate before each
addition, until the pink colour of the
chloroform layer is completely discharged and a greyish-blue
colour is obtained.
1 mL of 0.004 M benzethonium chloride is equivalent to 1.154 mg
of sodium alkyl sulfates,
expressed as C12H25NaO4S.

PREPARED BY: CHECKED BY: APPROVED BY:

TARUN TANDEL SURAJ PATEL APEXA GOHIL

Chemist, Production Executive, Quality Control Executive, Quality Assurance