检测设施
QC部门建筑面积约3000m²,共分为4个楼层,设有仪器检测、理化检测、微生物检测。仪器检测主要负责液相色谱检测、气相色谱检测及其他仪器检测;理化检测主要负责红外、紫外、旋光、水分、熔点测试、化学滴定测试及其他理化测试;微生物检测主要负责成品微生物、洁净区测试、生产用水测试。另设有留样室和稳定性实验室。
The construction area of the QC department is about 3000m², which is divided into 4 floors, including instrument testing, physical and chemical testing, and microbiological testing. Instrument testing is mainly responsible for HPLC, GC and other instrument testing; physical and chemical testing is mainly responsible for IR, UV, optical rotation, water, melting point testing, chemical titration testing and other physical and chemical testing; microbiological testing is mainly responsible for API microorganisms, clean area testing , process water testing. There is also a sample retention room and a stability laboratory.
实验室配置了高端仪器及设备,其中包括waters、安捷伦、岛津、万通、安东帕、马尔文、宾德等国际知名检测仪器。
The laboratory is equipped with high-end instruments and equipments, including waters, Agilent, Shimadzu, Metrohm, Anton Paar, Malvern, Binder and other international Well-known testing instrument.
检测设备Testing Instruments:
品牌 | 型号 | |
高效液相色谱仪HPLC | Waters | e2695/UV2489 |
高效液相色谱仪HPLC | 安捷伦Agilent | 1260Infinity |
高效液相色谱仪HPLC | 岛津Shimadzu | LC-20AD |
气相色谱仪GC | 安捷伦Agilent | 7890A/7697A |
气相色谱仪GC | 岛津Shimadzu | GC-2010 Plus |
傅里叶变换红外光谱仪IR | 岛津Shimadzu | IRPrestige-21 |
紫外可见分光光度计UV | 岛津Shimadzu | UV-2600 |
自动电位滴定仪Automatic Potentiometric Titrator | 瑞士万通Metrohm | 916 |
水分滴定仪Water Titrator | 瑞士万通Metrohm | 915/899 |
旋光仪Polarimeter | 安东帕Anton Paar | MCP300 |
TOC检测仪TOC | GE | 900 实验室型 |
激光粒度仪Laser Particle Analyzer | 马尔文Malvern | Mastersizer 3000 |
稳定性试验箱Stability test chamber | 宾德Binder | KMF 720/KBF 240 |
低床式压力蒸汽灭菌器Pressure steam sterilization | YAMATO | SQ810C |