Metformin Hydrochloride Metformin hcl usp/bp/ep Metformin
Metformin Hcl / Specification: USP, BP EP / Packing: 25kg/drum / Production capacity: 900 Tons/ annual Compectitve price have GMP
TEST ITEM |
STANDARDS REQUIRED |
TEST RESULTS |
Characters Appearance Identification B:IR-spectrum
E: reaction of chlorides Test Appearance of solution Related substances Cyanogunadine(imp.A) Any other impurity Total impurities Heavy metals Loss on drying Sulphated ash Residual solvents Methanol Assay% on dry basis |
White or almost white crystals
Consistent with the spectrum of metformin- hydrochloride CRS. (2.2.24) It gives reaction of chlorides. (2.3.1)
Clear(2.2.1) and colorless(2.2.2 Method II) (2.2.29) ≤0.02% ≤0.05% ≤0.2% ≤10ppm (2.4.8) ≤0.5% (2.2.32) ≤0.1% (2.4.14)
≤3000ppm 98.5—101.0% (2.2.20) |
white crystals
Complies Complies
clear and colorless
0.003% 0.004% 0.02% <10ppm 0.04% 0.02%
477ppm 99.9% |
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