當前頁面： 首頁 > 新聞中心新聞中心
質量報告單
|
PRODUCT NAME |
ALLOPURINOL |
BATCH NO |
20230312 |
|
|
ANALYSIS DATE |
2023.03.12 |
REPORT DATE |
2023.03.12 |
|
|
QUANTITY |
505KG |
STANDARD |
USP 36 |
|
|
TEST |
SPECIFICATIONS&LIMTIS |
RESULTS |
||
|
APPEARANCE |
WHITE OR ALMOST WHITE POWDER |
COMPLIES |
||
|
IDENTIFICATION |
CONFORM WITH IR SPECTRUM |
COMPLIES |
||
|
|
IMPURITY A NMT0.2 |
NOT DETECTED |
||
|
|
IMPURITY B NMT0.2 |
NOT DETECTED |
||
|
|
IMPURITY C NMT0.2 |
COMPLIES |
||
|
|
IMPURITY D NMT0.2 |
NOT DETECTED |
||
|
|
IMPURITY E NMT0.2 |
NOT DETECTED |
||
|
|
IMPURITY F NMT0.2 |
NOT DETECTED |
||
|
|
TOTAL IMPURITIES OTHER A,B AND C NMT0.3 |
COMPLIES |
||
|
|
INDIVIDUAL UNKNOWN IMPURITIES NMT0.1 |
COMPLIES |
||
|
LIMITED OF HYDRAZINE |
NMT 10PPM |
COMPLIES |
||
|
SULPHATED ASH(%) |
NMT 0.1 |
0.06% |
||
|
LOSS ON DRYING(%) |
NMT0.5 |
0.06% |
||
|
HEAVY METAL |
≤20ppm |
〈20ppm |
||
|
RESIDUE ON IGNITION |
≤0.1% |
0.05% |
||
|
SINGLE IMPURITY |
≤0.2% |
0.03% |
||
|
TOTAL IMPURITY |
≤1.0% |
0.04% |
||
|
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. |
||
|
ASSAY(%) |
98.0~102.0 |
99.09% |
||
|
CONCLUSION |
COMPLIES WITH USP36. |
|||
