Referance Specification, for more details, pls contact us for COA,MSDS and certification:
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Item
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Standard
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Test Results
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Identification
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A.H-NMR:Comply with the structure
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Complies
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B.LC-MS:Comply with the structure
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Complies
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C.The IR spectrum of sample should be identical with that of reference standard;
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Complies
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D.HPLC-ESI-MS
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
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Complies
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Crystallinity
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meets the requirements.
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Complies
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Loss on drying
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≤2.0%
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0.19%
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Heavy metals
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≤10 ppm
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<10ppm
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Water
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≤1.0%
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0.1%
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Sulphated ash
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≤0.5%, determined on 1.0 g.
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0.009%
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Related substances
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Unspecified impurities: for each impurity
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≤0.10%
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<0.10%
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Total Impurity
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≤0.5%
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0.18%
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Purity
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≥99.0%
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99.7%
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Assay
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99.0%~101.0% (anhydrous substance).
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99.8%
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Microbiological Analysis
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Total plate count
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≤1000cfu/g
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Complies
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Yeast and Moulds
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≤100cfu/g
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Complies
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E. Coli.
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Absent
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Negative
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Salmonella
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Absent
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Negative
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S.aureus
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Absent
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Negative
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Storage
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Preserve in well-closed, light-resistant and airtight containers.
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Complies
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