those susceptible to chemical hydrolysis)lEstablishing the level of protection to product formulations to moisture by primary packaging materials during their shelf lifelOptimizing the shelf-life stability of probioticslProviding a complementary method for monitoring changes in water content ...
In the absence of a companion monograph or chapter, the information generated from these studies may be disseminated to the user via other types of supporting documents including but not limited to the USP Certificate. USP RS在USP -NF中没有正式使用,它是按照USP RS在官方测试和分析中用于表征和...
I ndividual USP or NF monographs as well as certain General Chapters specify the USP Reference Standard(s) required for assay and test procedures. General Chapter <11> USP Reference Standards provides general informa-tion and instructions for proper use and storage. Consult the label text for...
注射剂通则-USP-药典.pdf,Accessed from by brunswick20 on Tue Feb 21 01:04:24 EST 2017 USP 40 General Requirements / á1ñ Injections and Implanted Drug Products 67 General Chapters General Tests and Assays General Requirements for Tests and Assays á1
• Water, Method I <921> : between 3.0% and 6.0%. General Chapters * Reagents & Reference Tables * Monographs 目的: USP-NF 各论作为公共标准,在一般的商业活动中发挥者重要作用。 含量测定和限度规定构成法定标准。 范畴: USP:原料药和制剂,包括复方制剂 ...
–Water(<921>) –SpecificRotation(<781S>) •ResidualSolvents •Microbial(<61>,<62>) USP<1226>Summary •Theintentofthischapteristoprovidegeneralinformationto laboratoriesontheverificationofcompendialprocedures thatarebeingperformedforthefirsttimetoyieldacceptable resultsutilizingthelaboratories’personnel,equ...
Where the titrimetric determination of water is required at the time a Reference Standard is to be used, proceed as directed for Method I under Water Determination á921ñ. Instrumental or microanalytical methods are acceptable for this purpose. When using typical amounts (about 50 mg of the...
生姜USP标准 USP Reference standards 11—Origin 2030.
• Water, Method I < 921> : between 3.0% and 6.0%. 通则(例如:色谱法<621> ): • 各论中应用的测试和方法的描述;• 配药的条件及操作的描述与标准;• 对药典要求的通用解释;• 描述通用的药品贮存、配方和包装操作,以及• 对药用原料和制剂生产商的通用指导原则例如:各论中描述--- • ...
•M ICROBIAL E NUMERATION T ESTS〈61〉: NMT 350 cfu/g Fondaparinux Sodium for Assay RS in water from the •W ATER D ETERMINATION, Method Ic〈921〉: It contains NMT Standard solution 20.0% (w/w).Sample solution: Transfer the contents of prefilled sy- ringes to a suitable ...