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