China Metformin Hydrochloride/HCl CAS 1115-70-4; 15537-72-1, Find details about China Pharmaceutical Raw Material, Pharmaceutical Intermediate from Metformin Hydrochloride/HCl CAS 1115-70-4; 15537-72-1
Analytical Items | Standard | |
Appearance | White or almost white crystals | |
Identification | B: IR-spectrum | Consistent with the spectrum of metformin hydrochloride CRS. (2.2.24) |
E: reaction of chlorides | It gives reaction of chlorides. (2.3.1) | |
Appearance of solution | Clear(2.2.1) and colorless(2.2.2) Method ‖ | |
Loss on drying | ≤0.5% (2.2.32) | |
Sulphated ash | ≤0.1% (2.4.14) | |
Methanol | ≤3,000PPm | |
Assay (on dry basis) | 98.5~101.0% (2.2.20) | |
Related substances | (2.2.29) | |
Cyanoguanideine (imp.A) | ≤0.02% | |
Any other imurity | ≤0.05% | |
Total impurities | ≤0.2% | |
Impurity F | ≤0.05% |