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USP 800 合规性指南：评估风险说明书
In spring 2018, the United States Pharmacopeia (USP) announced plans to revise general chapters <795> and <797>, which set standards for compounding nonsterile and sterile preparations. The goal was to better align these 2 chapters with USP <800> (“Hazardous Drugs — Handling in Healthc...
27 <90>Fetal Bovine Serum-Quality Attributes and Functionality Tests 牛胎儿血清—质量属性和功能检...
USP recently announced that it will delay the implementation of chapters on pharmaceutical compounding for nonsterile preparations (<795>) and sterile preparations (<797>), pending appeals of some sections in those chapters. As initially planned, USP <800> was deemed official as of December 1, ...
27 <90>Fetal Bovine Serum-Quality Attributes and Functionality Tests 牛胎儿血清—质量属性和功能检...
<795>PHARMACEUTICALCOMPOUNDING—NONSTERILEPREPARATIONS……2731 药物混合-非无菌制剂 <797>PHARMACEUTICALCOMPOUNDING—STERILEPREPARATIONS……2735 药物混合-无菌制剂 <801>POLAROGRAPHY……2752极谱法 <811>POWDERFINENESS……2754粉剂细度 <821>RADIOACTIVITY……2755放射性 ...
208 未分级和低分子量肝素的抗因子Xa和抗因子IIa测定 ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS 209 低分子量肝素的分子量定量测 定LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS 210 单糖分析 MONOSACCHARIDE ANALYSIS 211 砷盐检查法 ARSENIC...
Apparatus for Test and Assays 用于检查与含量分析的器具 ＜16＞AUTOMATED METHODS OF ANALYSIS……2491 自动化分析方法 ＜21＞THERMOMETERS……2497 温度计 ＜31＞VOLUMETRIC APPARATUS……2497 容量器具 ＜41＞WEIGHTS AND BALANCES……2499 砝码与天平 Microbiological Tests 微生物检查法 ＜51＞ANTIMICROBIAL ...
USP <795> Deploy best practices and guidelines that streamline compliance for nonsterile compounding applications. How We Help USP <797> Ensure sterile compounding is safe and compliant with evidence-based industry expertise. How We Help USP <800> Address the unique challenges of hazardous materials...