Function: | Cardiovascular Agents |
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Certification: | GMP |
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Solid |
Volatile: | Not Volatile |
Samples: |
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Items | Standard | Results |
Description | White or almost white ,crystalline powder | White ,crystalline powder |
Solubility | Freely soluble in water and in methanol, sparingly soluble in methylene chloride | Complies |
Identification | a) IR. Mexiletine hydrochloride RS | Complies |
b) Reaction of chloride | Complies | |
Appearance of solution | Clear and colourless | Clear and colourless |
Melting Point | 202-204ºC | 201-202ºC |
PH | 4.0~5.5 | 5.3 |
Residue Solvent | Ethyl acetate≤0.5% | 0.005% |
Impurity D | ≤0.1% | Not detected |
Related substances (HPLC) |
Impurity A≤0.1% | Not detected |
Impurity C≤0.1% | 0.0010% | |
Any single impurity≤0.1% | 0.07% | |
Total impurities≤1.5% | 0.07% | |
Sulfated ash | ≤0.1% | 0.09% |
Water | ≤0.5% | 0.3% |
Microbial Limits | Aerobic bacteria per 1g must not exceed the total number of 103 cfu | <10cfu |
Fungi and yeast per 1g must not exceed 102 cfu | <10cfu | |
Escherichia coli per 1g must not be detected | Not detected | |
Assay(Titration) | 99.0%~101.0% | 100.8 % |
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