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Item |
Standard |
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Structural data confirmation |
1. H-NMR: The data of structure are identical with reference standard |
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2. HPLC-MS: Ensure the molecular weight of main peak and fragment peak are identical with reference standard |
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3. IR:The data of IR are identical with that of reference standard |
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Purity(HPLC) |
≥99.0% |
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Related impurities |
Specific single impurity |
Meets EP/USP/BP standards |
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Non-specific single impurity |
≤0.10% |
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Total Impurities |
≤0.50% |
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Crystal form |
Meets EP/USP/BP standards |
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Loss on drying |
≤1.0% |
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Water |
≤1.0% |
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Inorganic salt |
≤0.1% |
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Heavy metals |
≤10 ppm |
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Assay |
99.0%~101.0%(According to EP/USP/BP standards) |
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Microbiological Analysis |
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Total plate count |
≤1000cfu/g |
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Yeast and Moulds |
≤100cfu/g |
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E. Coli. |
Absent |
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Salmonella |
Absent |
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S.aureus |
Absent |
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