Powder: | Yes |
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Customized: | Non-Customized |
Certification: | GMP, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | >99% |
Customization: |
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PRODUCT | METFORMIN HYDROCHLORIDE | PHARMACOPOEIA | EP9.0 | |
BATCH NO. | A-81411904109 | GROSS WEIGHT | 27.5Kg/Drum | |
BATCH QUANTITY | 2000KGS | NET WEIGHT | 25Kg/Drum | |
MANUFACTURE DATE | APR.17,2019 | RETEST DATE | MAR,2022 | |
ANALYSIS DATE | APR.18,2019 | REPORT DATE | APR.20,2019 | |
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 Impurity F Heavy metals Loss on drying Sulphated ash Residual solvents Methanol Assay% on dry basis Bulk Density Particle Size |
White or almost white crystals |
white crystals |
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Consistent with the spectrum of metformin- |
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hydrochloride CRS. (2.2.24) | Complies | |||
It gives reaction of chlorides. (2.3.1) | Complies | |||
Clear(2.2.1) and colorless(2.2.2 Method II) |
clear and colorless |
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(2.2.29) | ||||
≤0.02% | 0.0005% | |||
≤0.05% | 0.004% | |||
≤0.2% | 0.007% | |||
≤0.05% | <LOQ(LOQ=0.01%) | |||
≤10ppm (2.4.8) | <10ppm | |||
≤0.5% (2.2.32) | 0.05% | |||
≤0.1% (2.4.14) | 0.04% | |||
≤3000ppm |
731ppm |
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98.5-101.0%(2.2.20) | 99.8% | |||
Not less than 0.40g/ml | Comply | |||
100% pass 40mesh | Comply |
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