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質(zhì)量報(bào)告單
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PRODUCT NAME |
ALLOPURINOL |
BATCH NO |
20230312 |
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ANALYSIS DATE |
2023.03.12 |
REPORT DATE |
2023.03.12 |
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QUANTITY |
505KG |
STANDARD |
USP 36 |
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TEST |
SPECIFICATIONS&LIMTIS |
RESULTS |
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APPEARANCE |
WHITE OR ALMOST WHITE POWDER |
COMPLIES |
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IDENTIFICATION |
CONFORM WITH IR SPECTRUM |
COMPLIES |
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IMPURITY A NMT0.2 |
NOT DETECTED |
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IMPURITY B NMT0.2 |
NOT DETECTED |
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IMPURITY C NMT0.2 |
COMPLIES |
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IMPURITY D NMT0.2 |
NOT DETECTED |
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IMPURITY E NMT0.2 |
NOT DETECTED |
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IMPURITY F NMT0.2 |
NOT DETECTED |
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TOTAL IMPURITIES OTHER A,B AND C NMT0.3 |
COMPLIES |
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INDIVIDUAL UNKNOWN IMPURITIES NMT0.1 |
COMPLIES |
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LIMITED OF HYDRAZINE |
NMT 10PPM |
COMPLIES |
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SULPHATED ASH(%) |
NMT 0.1 |
0.06% |
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LOSS ON DRYING(%) |
NMT0.5 |
0.06% |
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HEAVY METAL |
≤20ppm |
〈20ppm |
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RESIDUE ON IGNITION |
≤0.1% |
0.05% |
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SINGLE IMPURITY |
≤0.2% |
0.03% |
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TOTAL IMPURITY |
≤1.0% |
0.04% |
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MICROBIOLOGICAL LIMIT |
TOTAL BACTERIA≤1000/g TOTAL NUMBER OF MOLDS AND YEASTS≤100/g E.coli MAY NOT BE DETECTED. |
320/g 20/g E.coli WAS NOT DETECTED. |
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ASSAY(%) |
98.0~102.0 |
99.09% |
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CONCLUSION |
COMPLIES WITH USP36. |
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