Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Audited by an independent third-party inspection agency
Product Name | Clarithromycin |
CAS | 81103-11-9 |
Appearance | White crystalline powder |
MF | C38H69NO13 |
MW | 747.95 |
Shelf Life | 24 months when properly stored |
Items
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Specifications
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Results
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Appearance
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White to almost white crystalline powder
|
white crystalline powder |
Solubility
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White to off-white, crystalline powder. Soluble in a cetone; slightly soluble in dehydrated alcohol, in me thanol, and in ac etonitrile, and in phosphate buffer at pH values of 2 to 5; practically insoluble in water.
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Conforms
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Identification
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IR:conforms to the spectrum of clarithromycin RS
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Conforms
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Specific optical rotation |
-94°--102°(anhydrous substance,1 0mg/ml me thylene chloride)
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-98°
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Crystallinity
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Meet the requirements
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Conforms
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pH
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8.0-10.0
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9.0
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Water
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≤ 2.0%
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1.1
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Related substances (HPLC)
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||
- Impurities exceed 0.4%
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≤4
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1
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Total impurity
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≤3.5
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1.6%
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Residue on ignition
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≤0.2%
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0.04%
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Assay (HPLC, on anhydrous basis)
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96.0 ~ 102.0%
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98.4%
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Additional test: Residual solvent (GC) |
Ethanol ≤ 5000ppm
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744ppm
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D ichloromethane≤600ppm
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Not detected
|
|
Conclusion
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It complies with USP40 standard.
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