SRI VYJAYANTHI LABS PVT. LTD.

SPECIFICATION AND STANDARD TESTING PROCEDURE

Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 1 of 11

1.0 Sampling

As per sampling procedure under SOP NO: SVLL/QC/SOP/011

2.0 Total composite sample: 30 g

2.1 Quantity of Sample for Analysis: 10 g

2.2 Reserved Sample:

Quantity: 20 g

Storage: AT Room Temperature.

3.0 Retest Period: 2 Years.

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 2 of 11

S. No. TEST SPECIFICATION

1. Description A white or almost white powder hygroscopic

Practically insoluble in ethanol 96%.It
2. Solubility
dissolves in dilute solutions of acids.
Identification
Shall pass the test
3. Phosphates
Shall pass the test
Magnesium
Appearance of solution
Solution S: Dissolve 1.5g at room
temperature in Carbon dioxide free Solution S is not more opalescent than
4
water R prepared from Distilled reference suspension III
water R and dilute to 50mL with the
same solvent
Free Glycerol & alcohol soluble
5 Max 1.5 %
impurities
6 Acidity Shall pass the test
7 Chlorides Max 0.15 %

.8 Phosphates Max 0.5 %

9 Sulphates Max 0.1%

10 Iron Max 150 ppm
11 Heavy metals Not more than 20 ppm
12 Loss on drying Max. 12.0 %
13 Mg content ( on dry basis ) 11.0 to 12.5 %
4.0 Specification:
5.0 Standard Testing Procedure:

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 3 of 11

5.1 Description :
White or almost white hygroscopic powder

5.2 Solubility:
Practically insoluble in ethanol 96%. It dissolves in dilute solutions of acids.

5.3 Identification.

Test for Phosphates:

Ignite 0.1 g in a crucible. Take up the residue with 5 mL of nitric acid R and heat on
a water-bath for 1 min. Filter and take the filtrate for test.
Mix 1 mL of the above solution with 2 mL of molybdovanadic reagent R. A yellow
color develops.
Preparation of Molybdovanadic:
Take 4gm Ammonium molybdate and 0.1 gm ammonium metavanadate in 70 mL of
water and grind until dissolved. Add 20 mL of Nitric acid and dilute to 100 mL with
water.
Reaction of magnesium: Take 15 mg of the sample and dissolve it in 2 mL of the
water. Add 1 mL of 6M Ammonia. A white precipitate is produced which is
dissolved by adding 1 mL of Ammonium Chloride solution (10.7 % w/v solution).
Add 1 mL of disodium hydrogen phosphate solution (9.0 % w/v). A White

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 4 of 11

Crystalline precipitate is produced.

5.4 Appearance of solution:

Reference Suspension III: Standard of Opalescence (30 mL) + Water (70 mL)
Standard of Opalescence: Dilute 15 mL of the Primary Opalescent Suspension to
1000 mL with water. This Suspension is freshly prepared and may be stored for 24
hr.
Primary Opalescent Suspension (Formazine suspension): To the solution of
Hexamethylenetetramine in the flask add 25 mL of Hydrazine sulphate solution.
Mix and allow standing for 24 hr. This suspension is stable for 2 months, provided
it is stored in a glass container free from surface defects. This suspension must not
adhere to the glass and must be well mixed before use.
Hexamethylenetetramine solution: In 100 mL glass- stopper flask, dissolve 2.5 g
of Hexamethylenetetramine reagent in 25 mL of water.
Hydrazine sulphate solution: Dissolve 1.0 g of Hydrazine sulphate in water and
dilute to 100 mL Allow to stand for 4-6 hr.
5.5 Free Glycerol & alcohol soluble impurities: Shake 1g with 25 mL of alcohol for
1 min. Evaporate the filtrate to dryness on a water-bath and dry the residue at 70º C
for 1 h. The residue weighs not more than 1.5%.

5.6 Acidity: To 1g of sample add 100 mL of water; add 0.1 mL of phenolphthalein

solution. Not more than 1.5 mL of 0.1 M HCl should be consumed.

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 5 of 11

Volume of 0.1N HCl x N

------------------------------------------- = mL
Weight of Sample x 0.1

5.7 Chlorides:

Take 0.035 g of sample in 10 mL of Water and add1.0 mL of dil.12.5% Nitric acid

and add1.0 mL of 5% Silver nitrate. Shake well. Compare with chloride Std.

Chloride standard:

Add 10 mL of Chloride Std. (5ppm) &5mL of distilled water, 1mL of 12.5% Dil.
Nitric acid and 1 mL of 5%silver nitrate sol.

After standing for 5 min, any opalescence in Test sol. is not more intense than that in
the Std.

Preparation of Chloride standard:

Chloride Std Stock solution (500 ppm): Dissolve 0.0824 g of Sodium chloride in
Distilled water and dilute up to 100 mL with the same distilled water.

Chloride Std sol(5 ppm): Dilute 1 volume of 0.0824%w/v solution of sodium

chloride in distilled water dilute to 100 volumes with the distilled water.
Immediately before use.

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 6 of 11

Preparation of 12.5% Dil. nitric acid: Dilute 12.5 mL of Nitric acid to 100 mL
with distilled water.

Preparation of 5% Silver nitrate: Dissolve 5 g of silver nitrate in distilled water

and dilute to 100 with the same distilled water.

5.8 Phosphates:

Take 0.2 gm of sample in 100 mL of distilled water Take 1.0 mL of solution and
make up to 100 mL with water. To this solution add 4 mL of Sulphomolybdic
reagent and 0.1mL Tin (II) chloride sol.

Phosphates standard:

In another Nesslers test tube take 2 mL of Phosphate standard (5ppm) solution &add
98 mL of water & 4 mL of Sulphomolybdic acid shake well and add 0.1 mL of
stannous chloride solution.

Wait for 5 min. and compared with Std.

Any color in test solution is not more intense than that in the standard.

Preparation of standard solution (500ppm PO4):

Dissolve 0.0716 g potassium Dihydrogen Ortho phosphate in distilled water and

dilute to 100 mL with the same distilled water.

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 7 of 11

Phosphate standard solution (5 ppm PO4):

Dilute 1 mL of the above solution to 100 mL with Distilled water.

Preparation of Sulphomolybdic reagent:

Dissolve with heating 2.5 g of Ammonium molybdate in 20 mL of water. Separately,

with care add 28 mL of H2SO4 to 50 mL of water & cool. Mix the two solutions and
dilute to 100 mL with water.

Preparation of Stannous chloride /Tin (11) chloride reagent:

Take 1 gm of Tin (II) chloride and dilute to 10 mL with 2M HCl.

5.9 Sulphates:

0.15 g of sample add 15 mL of distilled water,1.0 mL of 25% BaCl2,1.5 mL of 10

ppm sulphate standard,0.5 mL of 5M CH3COOH

Sulphate standard:

TO 15 mL of 10 ppm sulphate standard add 1 mL of 25% BaCl2 Solution and 1.5 mL

of 10 ppm sulphate standard. Then add 0.5 mL of 5 M Acetic acid.

Preparation of sulphate standard solution (1000 ppm):

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 8 of 11

Dissolve 0.181 g of Potassium sulphate in Distilled water and dilute up to 100 mL

with the same distilled water.

Sulphate standard solution (10 ppm):

Dilute 1 mL of above solution to 100 mL with distilled water. Immediately before use

Preparation of 30% Acetic acid (5M):

Dilute 30g (29.0 mL) of Glacial acetic acid to 100 mL with distilled water.

Preparation of 25% BaCl2:

Dissolve 25g of BaCl 2 in distilled water and dilute to 100 mL with the same distilled
water.

5.10 Iron:

Test solution:

Dissolve 67 mg in water and dilute to 10 mL with DM water. This solution complies

with limit test for Iron (150 ppm)

Dissolve a prescribed quantity of sample in 10 mL of DM water add 2 mL of 200 g/L

solution of Citric acid ( 0.5 g of 10 mL of water , add 0.1 mL of Mercapto acetic acid
mix make alkaline with 10 M Ammonia and sufficient water to Produce 20 mL . No

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 9 of 11

pink color is observed.) and 0.1 mL of Thioglycollic acid. Mix make alkaline with
Ammonia and dilute to 20 mL with water

Prepare a Standard in same manner by using 10 mL of Iron std. solution (1 ppm Fe)

After 5 min any pink color in Test solution is not more intense than that of Std.

5.11 Heavy metals:

Test solution:

To 20 mL of sample solution (2.5g in 50 mL) add 15 mL of HCl and shake well with
25 mL of Methyl isobutyl ketone. Allow to stand for 2 min. Separate Aq. layer and
evaporate to dryness. Dissolve the residue in 2.5 mL of Acetic acid and dilute to 20 mL
water. Take 12 mL of the solution and compare with std. if it complies the limit test
for Heavy metals.

Standard solution:

10 mL of Lead 1 ppm solution add 2 mL of buffer solution (pH 3.5) and 1.2 mL of
Thioacetamide reagent
Blank solution: To 2 mL of sample add 10 mL of water add 2 mL of buffer solution
(pH 3.5) and 1.2 mL of Thioacetamide reagent
The test solution is not more intense than that standard solution.
The test is invalid if the standard solution doesn’t show any slight brown color
compared to Blank.

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 10 of 11

5.12 Loss on drying:

Weigh a dried glass stoppered shallow weighing bottle (W 1). Transfer 1 g of the
sample to the bottle. Accurately weigh the bottle and its contents (W 2). Place the
loaded bottle in a drying chamber. Dry the sample for 4 hrs. at 150C. After drying
cool the bottle with contents in desiccator and weigh the bottle accurately again
(W3). Note the readings.
W2 - W3
% LOD = -------------- x 100
W2 – W1

5.13 Magnesium content (on dry basis):

Take 1.0 g sample and dry at 150°C for 4 hours. Dissolve 0.200 g in 100 mL distilled
water. Add 6.0 mL of 1.0 N HCL and 10 mL of ammonia ammonium buffer solution
and add 50 mg of Eriochrom black-T. Titrate with 0.05M sodium edentate until the
color changes from violet to full blue.

Calculation as Magnesium content:

TV X Normality of 0.05 M EDTA X 2.43

Weight of sample taken in g

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date
 SRI VYJAYANTHI LABS PVT. LTD.
SPECIFICATION AND STANDARD TESTING PROCEDURE
Name of the Product: MAGNECIUM GLYCERO PHOSPHATE
STP NO : STP/FP/MGP/PR001-00 Effective Date:
Pharmacopoeia Ref: EP Review Date:
Department: Quality Control Page 11 of 11

Prepared by (QC) Reviewed by (QC) Approved by (QA)

Name V.M.REDDY K.V.SUBBA RAJU C.SRINIWAAS
Signature
Date