安全性内毒素USP <85> 生物负载USP <61>, <62>, <1115> 无菌USP <71> 其它外观USP <1>, <790> pHUSP <791> 表1:mRNA原料的质量属性 随后,该指南草案详细介绍了鉴定、定量、RNA完整性和纯度的方法,汇总见下表。 鉴定方法A:通过NGS鉴定编码的RNA序列 方法B:通过桑格测序鉴定 方法C:通过RT-PCR鉴定 定...
(A) RP–HPLC mRNA Integrity Gel electrophoresis Product related impurities - dsRNA Immunoblot Residual DNA template qPCR Endotoxin USP <85> Bioburden USP <61>, <62>, <1115> Sterility USP <71> Appearance USP<1>, <790> pH USP <791> IDENTITY • METHOD A: IDENTITY OF ENCODED RNA SEQUENCE...
2.Does USP 795 state that we need to perform sterility testing on non-sterile products?No, sterility testing is not required for non-sterile drug products. Performing USP <61> and USP <62> testing is the expectation for non-sterile products.840 Research Parkway, Ste. 546 • Oklahoma ...
USP mRNA V疫苗章节 mRNA 疫苗分析方法规程.pdf,USP mRNA Vaccine Chapter XXX ANALYTICAL PROCEDURES FOR mRNA VACCINES For decades, messenger RNA (mRNA) technology has been explored for vaccines for infectious diseases like flu, Zika, rabies, and cytomegalo
〈1113〉MICROBIAL CHARACTERIZATION, IDENTIFICATION, AND STRAIN TYPING微生物特性、鉴定和菌株分型 〈1115〉BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS非无菌药品和产品的生物控制 〈1116 〉MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ...
USP-1396309 Metformin Hydrochloride (200 mg) 1115-70-4 2925299000 USP-1396310 Metformin Related Compound A (30 mg) (1-Cyanoguanidine) 461-58-5 2926200000 USP-1396331 Metformin Related Compound B (25 mg) (1-Methylbiguanide hydrochloride) 1674-62-0 ...
USP-1009978 N-Acetyl-D,L-Methionine (100 mg) (N-Acetylmethionine) 1115-47-5 2930909265 USP-1010022 N-Acetylglucosamine (200 mg) 7512-17-6 2932999000 USP-1010081 N-Acetyl-L-Leucine (100 mg) (Acetyl-L-leucine) 1188-21-2 2924190002 ...
<11>USP对照标准品 检测和含量分析的仪器 <17>处方容器标签 <31>容量器具（如容量瓶、移液管、滴定管，各种规格的误差限度）<41>天平 微生物检测 <51>抑菌效力检查法 <55>生物指示剂：耐受性能检测 <61>非无菌产品的微生物限度检查：微生物计数法 <62>非无菌产品的微生物限度检查：控制菌检查法 <63>支原体...
1115-70-4 1396309-200MG 200MG Metformin hydrochloride 二jia双胍 盐酸盐 98418-47-4 1441298-200MG 200MG Metoprolol succinate United States Pharmacopeia (USP) Reference Standard 1500502-1SET 1SET Particle Count Set 微粒计数集 9002-88-4 1546707-3STRIPS 3STRIPS High Density Polyethylene 高密度聚乙...
药用制剂和制药过程使用的物质接受标准1112microbialcharacterizationidentificationandstraintyping非无菌药物产品水活性测定应用1113microbiologicalattributesofnonsterilepharmaceuticalproducts非无菌药品中的微生物分布1115bioburdencontrolofnonsteriledrugsubstancesandproducts非无菌药物和产品的生物负载控制1116microbiologicalcontroland...