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1 Kilogram |
Negotiable |
Ketoconazole 65277-42-1 C26H28Cl2N4O4
1.strict Quality control:
Strictly in accordance with Chinese GMP(2010 version), guidelines issued by FDA,EDQM, and ICH relevant regulations, we have established a sound quality assurance system, implementing regular supervision and management in overall process of drug production.
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Introduction
Ketoconazole is a synthetic antifungal drug used to prevent and treat fungal skin infections, especially in immunocompromised patients such as those with AIDS or those on chemotherapy. Ketoconazole is sold commercially as an anti-dandruff shampoo, topical cream, and oral tablet.
Specifications
Ketoconazole
CAS No.: 65277-42-1
synthetic antifungal drug used to prevent and treat fungal skin infections.
Ketoconazole
CAS No.: 65277-42-1
Certificate:GMP
Ketoconazole specs:
Product |
Ketoconazole |
Identification No. |
1C090068 |
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Product Batch No. |
KE090410 |
Product date |
Apr. 15,2009 |
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Batch size |
500kg |
Report date |
Apr.22,2009 |
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Specification |
25kg/drum |
Expiry date |
Mar. 2013 |
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CERTIFICATE OF ANALYSIS |
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Items |
Standard |
Results |
|||
Characters |
white or almost white powder |
Qualified |
|||
Identification |
Meets the requirements |
Qualified |
|||
Melting range |
148°C ~ 152°C |
148.0~ 150.0°C |
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Appearance of solution |
Meets the requirements |
Qualified |
|||
Organic volatile impurities |
Meets USP30 |
Qualified |
|||
Specific rotation |
-1° ~ +1°(USP30) |
0° |
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Chromatographic purity |
Meets the requirements |
Qualified |
|||
Heavy metals |
≤0.002% |
Qualified |
|||
Loss on drying |
≤0.5% |
0.10% |
|||
Residue on ignition |
≤0.1% |
0.05% |
|||
Assay |
98.0% ~ 102.0%(USP30) |
99.69% |
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CONCLUSION: |
This is certify that the product complies to the standards of USP29,EP5.0,BP2005 |
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Supervisor |
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QC |
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Analyst |
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Packing: 25kgs/drum or as per your requirements
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