Sr. No |
Test |
Specification |
1 |
Description |
White crystals |
2 |
Solubility |
Freely soluble in water, slightly soluble in
alcohol, practically insoluble in acetone and in methylene
chloride. |
3 |
Identification |
A. Melting Point: - 222 deg C. to 226 deg C. |
B. IR Spectrum: - Examine by infrared
absorption spectrophotometer, comparing with the spectrum
obtained with Metformin hydrochloride. |
C. By TLC: - The principal spot in the
chromatogram obtained with the test solution is similar in
position, color and size to the principal spot in the
chromatogram obtained with reference solution. |
D. Color test: - A pink color develops |
E. Chloride: - It gives reaction of chlorides. |
4 |
Appearance of solution |
Solution (10% in water) is clear and colorless |
5 |
Related substance by HPLC |
Cyanoguanidine |
N. M. T. = 0.02% |
Any other Impurity |
N. M. T. = 0.1% |
Total Impurity |
N. M. T. = 0.3% |
6 |
Heavy metals |
Not More Than 10 PPM |
7 |
Loss on drying |
Not More Than 0.5% |
8 |
Sulphated ash |
Not More Than 0.1% |
9 |
Assay |
98.5% - 101.0% |
Sr. No |
Test |
Specification |
1 |
Description |
White granules |
2 |
solubility |
Freely soluble in water, slightly soluble in alcohol
practically insoluble, in acetone and methylene chloride |
3 |
Identification |
Identification for Metformin HCI complies with the
SAP/IPM10/01/08. |
4 |
Loss on drying |
Maximum 2.0% |
5 |
Related substances (By HPLC) (1) Individual impurity (2)
Total impurity |
Not more than 0.1 % Not more than 0.5 % |
6 |
Residue on ignition |
Maximum 0.1% |
7 |
Heavy metals |
Maximum 0.001% |
8 |
Assay: |
|
|
Each 100 mg granules contains: |
|
|
Metformin Hydrochloride BP 95mg |
Between 95.0 to 105.0% of label claim. (Between 90.25mg to
99.75mg) |
9 |
Particle Size Distribution |
30 mesh: maximum 40 % retained. 60 mesh: maximum 50 %
retained. 200 mesh : maximum 80 % retained . |