Method Ic (Coulometric Titration)方式Ic(库仑滴定) Principle— The Karl Fischer reaction is used in the coulometric determination of water. Iodine, however, is not added in the form of a volumetric solution but is produced in an iodide-containing solution by anodic oxidation. The reaction cell us...
1、Methodlb(ResidualTitration)方式lb(残留滴定)PrincipleSeetheinformationgiveninthesectionPrincipleunderMethodIa.Intheresidualtitration,excessReagentisaddedtothetestspecimen,sufficienttimeisallowedforthereactiontoreachcompletion,andtheunconsumedReagentistitratedwithastandardsolutionofwaterinasolventsuchasmeth 2、anol.The...
Method Ic (Coulometric Titration) 方法Ic(库仑滴定) Principle— The Karl Fischer reaction is used in the coulometric determination of water. Iodine, however, is not added in the form of a volumetric solution but is produced in an iodide-containing solution by anodic oxidation. The reaction cell ...
Method Ic (Coulometric Titration) 方法Ic(见见滴定) Principle— The Karl Fischer reaction is used in the coulometric determination of water. Iodine, however, is not added in the form of a volumetric solution but is produced in an iodide-containing solution by anodic oxidation. The reaction ...
水分:依法检查(USP32-NF27,921,Method Ic),水分不得过0.3% 炽灼残渣:依法检查(USP32-NF27,281),遗留残渣不得过0.1% 重金属:依法检查(USP32-NF27,231,MethodⅡ),含重金属不得过百万分之二十 有关物质: 稀释液、溶液A、溶液B、峰鉴别溶液和色谱条件:按含量测定项下的要求 对照溶液的制备:使用按含量测定...
a portion of about 0.2g, accurately weighed.Calculate the percentage of each individual insulin re-•W ATER D ETERMINATION , Method Ic 〈921〉: NMT 8.0%lated protein (%i x ) in the portion of Insulin Glargine ADDITIONAL REQUIREMENTS taken:•P ACKAGING AND S TORAGE : Preserve...
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
•MethodTransferand/orMethodVerification(ChemistryandWork) USPMonograph(API) TypicalTests •Identification –IR(<197K>) –HPLCRT •Assay –Titration –HPLC •InorganicImpurities –ROI(<281>) –Heavymetals(<231>, <232) •OrganicImpurities –HPLC –GC •SpecificTests –Water(<921>) –Spec...
5、c Acid, Glacial, TS Determine the water content of a specimen of glacial acetic acid by the Titrimetric Method (see Water Determination 921). If the acid contains more than 0.05% of water, add a few mL of acetic anhydride, mix, allow to stand overnight, and again determine the wate...
•P H 〈791〉: 6.0–8.0, in a solution, at 20°–25° (2.5% w/v)Sensitivity check solution: 0.01mg/mL of USP •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〉...