Standard testing procedure lactose

Storage Requirements:
Store protected from light and moisture.

Sampling:
Sample from each container / bag, if the consignment is of 03 or less than three containers / bags. If the number of containers / bags is more than 03and are up to 100, sample at randomly using the formula root (n) +1 where n is the number of containers/bags in the consignment. For the consignment of more than 100 containers/bags, sample additional containers/bags for every 100 containers/bags and thereafter. Collect a minimum of 5g from each of the randomly selected containers/bags in to individually no toxic, self sealing transparent polyethylene bearing ‘Sample for Analysis label kept in another transparent self sealing polythene bag. After completion of sampling return rest sample on the same container. Collect control sample in Pet bottle/Glass bottle.

Quantity of Composite Sample:

122 g

Quantity of Control Sample:

2 X 122 g

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

Solubility: Freely but slowly soluble in water; practically insoluble in ethanol (95 per cent).

Identification:

Test A may be omitted if tests B and C are carried out. Tests B and C may be omitted if test A is carried out.

A. By IR
B. A red precipitate is formed
C. A red colour develops..

Appearance of solution: The solution is clear and not more intensely coloured than reference solution. BYS7.

Acidity or alkalinity: The solution is colourless and not more than 0.4 ml of 0.1M sodium hydroxide is required to change the colour of the solution to pink.

Specific optical rotation: +54.4° to +55.9°

Light absorption: Absorbance maximum at 400nm

Arsenic: NMT 1 ppm

Heavy Metals: NMT 5ppm

Microbial contamination: It complies with the test for E.coli and salmonella

Sulphated ash: NMT 0.1 per cent

Water: 4.5 to 5.5 per cent
.

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

Solubility: Freely but slowly soluble in water
Practically insoluble in ethanol (95 per cent).

Identification:
Test A may be omitted if tests B and C are carried out. Tests B and C may be omitted if test A is carried out.

A. By IR
B. To 5 ml of a saturated solution add 5 ml of 1 M sodium hydroxide and gently warm the mixture ;the
liquid becomes yellow and then brownish-red. Cool to room temperature and add 0.2 ml of potassium
cupri-tartarate solution; a red precipitate is formed.
C. Heat 5 ml of a 5 per cent w/v solution with 5 ml of 10 M ammonia in a water-bath at 80º for 10
minutes; a red colour develops..

Appearance of solution: Dissolve 1.0 g in water by heating to 50, dilute to 10 ml with water and allow to cool.
The solution is clear and not more intensely coloured than reference solution BYS7.

Acidity or alkalinity: Dissolve 6 g in 25ml of carbon dioxide free water by boiling, cool and add 0.3 ml of
Phenolphthalein solution. The solution is colourless and not more than 0.4 ml of 0.1M sodium hydroxide is required to change the colour of the solution to pink.

Specific optical rotation: Determined in a solution obtained by dissolving 10.0 g in 80 ml of water by heating to 50, allowing to cool, adding 0.2 ml of 6M ammonia, allowing to stand for 30 minutes and diluting to 100.0 ml with water.

Calculation:

SOR = Angle of Rotation X 100

2 X Sample Weight

Light absorption: Dissolve 1.0 g in boiling water and dilute to 10 ml with the same solvent (solution A). Absorbance of solution A measured at the maximum

at about 400nm, not more than 0.04.
Dilute 1 ml of solution A to 10 ml with water.
When examined in the range 210 nm to 300 nm, absorbance is not more than 0.25 in the range 210 nm to 220 nm and not more than 0.07 in the range 270 nm to 300 nm.

Arsenic: Dissolve 10.0 g in 50 ml of water and add 10 ml of stannated hydrochloric acid AsT; the resulting solution complies with the limit test for arsenic (1 ppm).

Heavy Metals: Dissolve 4.0 g in 20 ml of warm water 1.0 ml of 0.1 M hydrochloric acid and sufficient water to
produce 25 ml. The solution complies with the limit test for heavy metals, Method A( 5ppm)

Microbial contamination: Total microbial count not more than 100 per gm. 1.0 gm for free salmonella and shigella.

Sulphated ash: Determined in the following manner. To 1.0 g add 1 ml of sulphuric acid, evaporate to dryness on a water-bath and ignite to constant weight.

Calculation:

After Ignition Wt. X 100

Before Ignition Wt.

Reporting: Report in percentage:

Water: The water content is determined with suitable Karl Fischer apparatus.
Procedure: Take about 30 to 40 ml of methanol & 1 ml of formaldehyde and methanol in neutralize the solvent with standard K.F. reagent, than accurately about 5.0 gm of sample and transfer in to titration vessel then titrate with K.F. reagent to end point.

Calculation:

% of water = V x F x 100

W x 1000

Where,

V=Volume of K.F. reagent consumed for titration.

F=Factor of K.F. reagent.

W=Weight of the sample taken.

Reporting: Report in percentage.

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