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Active Pharmaceuticals

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  • COA
Name: Metformin hydrochloride
CAS No.: 1115-70-4
Formula: C4H12ClN5
Molecular Weight: 165.66
Synonyms: Diaformin;Dialon;Diformin;Diformin Retard; Dimefor;Fornidd;Geamet; Glucomin;Glucomine; Gluconil;Glucophage; Glucophage 850; Glucophage Forte;Glucophage Retard;Glucophage SR;Glufor; Gluformin;Glumeformin; Glumetza;Glumin;Glupermin;Glyceriphage;Glyciphage;Glycon;Metomin;Miformin;N,N-Dimethylbiguanide hydrochloride;N,N-Dimethylbiguanidinium chloride;N1,N1-Dimethylbiguanide hydrochloride;Orabet;Siamformet;Walaphage;Biguanide, 1,1-dimethyl-, monohydrochloride(8CI);Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride (9CI);1,1-Dimethylbiguanide hydrochloride;
EINECS: 214-230-6
Melting Point: 223-226 °C(lit.)
Boiling Point: 224.1 °C at 760 mmHg
Flash Point: 89.3 °C
Appearance: crystalline solid

Metformin hydrochloride is a biguanide oral hypoglycemic agent , also known as Glucophage, its hypoglycemic effect is weaker than phenformin, the main role is to reduce the glucagon secretion of A cells ,and to promote the conversion of glucose to glycogen, its characteristic effect including that it does not stimulate pancreatic β-cells to secrete insulin .

Metformin hydrochloride is clinically used for the treatment of type Ⅱ diabetes patients who are not satisfied with simple diet control, especially patients with obesity and hyperinsulinemia, usage of this drug not only displays no hypoglycemic effect, but also there may be weight loss and hyperinsulinemia effect. For some patients with poor efficacy of sulfonylurea ,it may be effective, if it is used with hypoglycemic drugs including sulfonylurea, intestinal glucosidase inhibitors or thiazolidinediones, the results are better than used alone. It can also be used in patients with insulin therapy to reduce the amount of insulin.

Test Items Specification Results
Description White Crystalline Powder White Crystalline Powder
Identification Positive Positive
Assay(by HPLC) 98.0~102.0% 99.24%
Absorbance(E1cm) 465~495 482.5
Melting Point 191~195°c 193.5~195.0°c
Loss On Drying 0.5%MAX 0.19%
Specific Rotation +288°~+298° +290.2°
Residue On Ignition 0.1%MAX 0.03%
Related Substances Total:1.5%MAX <1.3%
Related Substances Single:0.5%MAX <0.4%
Residue Solvents 0.2%MAX 0.10%
Heavy Metals 20PPm max <10PPm
Conclusion The specification conform with enterprise standard.

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