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质量体系
证书
审计历史
-
2016
·非那雄胺和黄体酮通过美国FDA检查
·黄体酮通过欧洲EDQM检查 -
2019
·非那雄胺、黄体酮、布地奈德通过FDA检查
·非那雄胺通过PMDA检查 -
2020
·醋酸环丙孕酮通过TGA检查
-
2021
·奥卡西平、甲泼尼龙通过湖北省药品监督管理局检查
-
2023
· 奥卡西平，度他雄胺通过韩国MFDS官方审计
-
2024
· 醋酸环丙孕酮通过EDQM审计
主要 QC 仪器清单
| 仪器 | 型号 | 制造商 |
| HPLC | 1100 | Agilent |
| 1200 | Agilent | |
| 1260 | Agilent | |
| 1290 | Agilent | |
| LC-20AT | Shimadzu | |
| LC-2030C PLUS | Shimadzu | |
| Ultimate 3000 | ThermoFisher | |
| Waters e2695 | Waters | |
| GC | 6890 | Agilent |
| 7697A | Agilent | |
| 7890 | Agilent | |
| GC-2030AF | Shimadzu | |
| IR | Avatar 380/iS10 | NICOLET |
| ALPHA-T | BRUKER | |
| UV-Vis | UV-2600/2000/1800 | Shimadzu |
| AAS | AA7000 | Shimadzu |
| Polarimeter | Autopol V/ⅠS2 | Rudolph |
| Autopol Ⅳ-T | Rudolph | |
| Laser Mastersizer | Mastersizer 3000 | Malvern |
| HELOS-RODOS | SYMPATEC | |
| TOC | TOC-VWP | Shimadzu |
| HTY-DI1500 | TAILIN | |
| Karl-Fisher Titrator | KF870/831/915 | Metrohm |
| Potential Titrator | 905/916 | Metrohm |
| Endotoxin Detector | PKF-96 | ACC |
| Air Jet Sieve | 200LS | Hosokawa alpine |
| pH Meter | PHS-3E | REX |
| Conductivity Meter | DDS-307 | REX |
| Temperature and Humidity Cabinet | Climacell 707 | MMM |
| Labonce-380GS | Labonce | |
| LHH-250SD | BLUEPARD | |
| CTHI-150B | STIK |
