主要从事化学药品、抗生素药品、生化药品和药用辅料的磨练检测,尺度研究等事情;可检项目百余项,在上市药物的质量评价与尺度提高、入口药品注册复核、仿制药质量与疗效一致性评价复核、国家药品尺度物质的协作标定等方面能力突出。作为WHO-PQ实验室,还承接部门外洋药品的检测使命。化药室现在拥有高级职称人yuan6人、博士3人、硕士9人,手艺主干多ci赴海内外著名科研院所和药检机构交流会见;配有AB 5500 HPLC-MS、离子色谱仪、液相色谱仪(配有二极管阵列、蒸发光散射及示差折光检测器)、X射线衍射仪、激光粒度仪、傅立叶红外光谱仪等一系列大型细密仪器装备。化学尊龙凯时室建设至今,精彩完成磷器年度国家药品专项抽验事情,并在“国家药品评价性抽验”、历版《中国药典》起草和复核、化学药品尺度提高行动妄想等专项事情中效果卓著。
We are mainly engaged in the analysis and testing of chemical drugs, antibiotics, biochemical drugs and pharmaceutical excipients, as well as in developments of the drug quality specifications. We have the ability to carry out hundreds of testing items and particularly strong in the quality assessments and testing method improvements for marketing drug product, validation and verification of standard specification for import drugs, quality and efficacy evaluation of generic drug, as well as in the nationally coordinating calibration of reference substance. As a WHO-PQ Laboratory, we undertake some foreign business.. In our department, 6 technicians obtained senior professional title, 3 with PhD degree and 9 with master degree. Most of our key staffs took part in the exchange program with top science institutes and drug testing institutes from domestic and worldwide. We are equipped with many advanced instruments including HPLC-TQMS (AB5500), Ion Chromatograph, HPLC with PDA, ELSD or RID detectors, X-ray Diffractometer, Laser Particle Size Analyzer, Fourier Transform Infrared spectrometer, etc. Since its establishment, we have accomplished remarkable tasks in the Annual National Special Drug Sampling & Testing Project. We have also performed extraordinally well in the program of Chinese Pharmacopoeia drafting and reviewing , the National Chemical Drug Quality Standard Improvement Plan, and so on.
部门座右铭 务实创新,勇于继续