standard testing procedure dicyclomine hydrochloride

Storage Requirements:
Store protected from light and moisture.

Sampling:
Sample equal quantity from each container / bag. Collect a minimum of 5g from each container/bag sample into individual, self –sealing clear polythene bag kept in another clear self sealing polythene bag bearing ‘Sample for Analysis,lable.After completion of sampling return rest sample on same container. Collect control sample in Pet Bottle/Glass Bottle.
Quantity of Composite Sample:

30 g

Quantity of individual Identification
0.0100 g from each and every container /bag.

Quantity of Control Sample:

2 X 30 g

Description: A white or almost white, crystalline powder; odourless or almost odourless.

Solubility: Freely soluble in ethanol (95 per cent) and in chloroform; soluble in water, practically insoluble in ether.

Identification:

A. By IR.
B. The aqueous layer is blue and the chloroform layer is colourless.
C. A white precipitate is produced.

Related Substances:
Any secondary spot in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution

Sulphated Ash: NMT 0.1 %w/w.

Loss on drying: NMT 1.0 %w/w.

Assay: 99.0% to 101.0%w/w on the dried basis.

Description: A white or almost white, crystalline powder; odourless or almost odourless.

Solubility: Freely soluble in ethanol (95 per cent) and in chloroform
Soluble in water
Practically insoluble in ether.

Identification:

A. By IR.

B. To 3ml of a 0.1 per cent w/v solution of sodium dodecyl sulphate, add 5 ml of chloroform and 0.05ml
of a 0.25 per cent w/v solution of methylene blue mix gently and allow to separate; the chloroform
Layer is blue. Add 20 mg of the substance under examination dissolved in 2ml of water, mix gently
and allow to separate; the aqueous layer is blue and the chloroform layer is colourless. The aqueous
layer is blue and the chloroform layer is colourless.

C. Dissolve 10mg in 5ml of water and add 0.2ml of 2 M nitric acid and 0.5ml of silver nitrate solution;
a white precipitate is produced.

Related Substances: Determine by thin-layer chromatography

Mobile phase: A mixture of 50 volumes of 1- propanol, 30 volumes of ethyl acetate, 15 volumes of water and 5 volumes of strong ammonia solution.

Test solution: Dissolve 0.5g of the substance under examination in 10 ml of methanol.

Reference solution: Dilute 5 ml of the test solution to 50 ml with methanol and mix. To 2ml of this solution add sufficient methanol to produce 100ml.

Apply to the plate 10µl of each solution. After development, dry the plate in air and spray with dilute potassium iodobismuthate solution. Any secondary spot in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution

Sulphated Ash:
Determined 1.0 gm sample in silica crucible ignite for 800ºC and cool add 1 ml of sulphuric acid or ignite & calculated ash.

Reporting: Reporting as per %.

DOCUMENT CHANGE HISTORY

Revision No.	Changes
00	First Time Prepare
01	Periodic Revision and Review of Formating Standard Testing Procedure & Formate
02	Periodic Revision and Review of Formating Standard Testing Procedure & Formate
03	Periodic Revision change