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CERTIFICATE OF ANALYSIS
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Product Name: Anhydrous vidarabine |
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Batch No. : 2301001 |
Quantity: 300.2kg |
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Analysis according: QS-01-050(1)-02 |
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Date of Production: Jan. 20, 2023 |
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Test Date: Feb. 01,2023 |
Date of Report: Feb. 03,2023 |
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Expiry date: Jan. 19, 2025 |
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Items |
Requirements |
Results |
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(1) |
Description |
White, tiny needle-shaped crystal or crystalline powder; odourless, tasteless |
Complies |
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(2) |
Identification |
(1)show positive reaction |
Complies |
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(2)the retention time complies to standard |
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(3)max absorption at 259nm; min absorption at 228nm; |
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(4)Infrared absorption |
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(3) |
PH |
6.0~7.0 |
6.3 |
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(4) |
Transmission |
≥98.0% |
99.8% |
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(5) |
Relate impurities |
≤1.0% |
0.1% |
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(6) |
Loss on drying |
≤0.5% |
0.2% |
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(7) |
Residue on ignition |
≤0.1% |
0.1% |
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(8) |
Heavy metals |
10ppm |
Complies |
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(9) |
Specific rotation |
-56.0 º ~65.0º |
-58.2º |
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(10) |
Assay(HPLC) |
98.0%~102.0% |
100.0% |
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Conclusion: Meet the requirement |
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