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Metformin Hydrochloride Technical Grade
Metformin is an oral anti-diabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of type 2 diabetes, particularly in overweight and obese people and those with normal kidney function. Evidence is also mounting for its efficacy in gestational diabetes, although safety concerns still preclude its widespread use in this setting. It is also used in the treatment of polycystic ovary syndrome and has been investigated for other diseases where insulin resistance may be an important factor.
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Analytical specifications
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Test
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Specification
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Description
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White crystals
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Solubility
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Freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.
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Identification
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- Melting point: - 222 oC To 226 oC.
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- Ir spectrum: Examine by infrared absorption spectrophotometer, comparing with the spectrum obtained with metformin hydrochloride.
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- 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.
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- Color test: A pink color develops
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- Chloride: It gives reaction of chlorides.
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Appearance of solution
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Solution (10% in water) is clear and colorless
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Related substance by hplc
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Cyanoguanidine
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N. M. T. = 0. 02%
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Any other impurity
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N. M. T. = 0. 1%
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Total impurity
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N. M. T. = 0. 3%
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Heavy metals
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Not more than 10 ppm
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Loss on drying
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Not more than 0. 5%
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Sulphated ash
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Not more than 0. 1%
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Assay
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98. 5% - 101. 0%
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