EDQM biological reference preparation for rabies vaccine (inactivated) for veterinary use [0.03%]
狂犬病（失活）兽用疫苗生物参考品(欧洲药典委员会)
A Daas,L Bruckner,C Milne
A Daas
Rabies is a deadly zoonotic disease. Control of rabies in animals by vaccination is an important strategy to protect humans from infection and control the spread of the disease. Requirements for the quality control of rabies vaccines (inact...
F De Mattia,C Hendriksen,K H Buchheit et al.
F De Mattia et al.
The consistency approach for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters during the whole production process. By using highly sensi...
Quantification of low levels of methionine oxidation in erythropoietin drug substance [0.03%]
一种定量促红细胞生成素药物活性成分中低水平甲硫氨酸氧化的方法
C Romera,A F Bristow,C Jones
C Romera
A pharmacopoeial monograph under development for recombinant human erythropoietin (rhEPO) drug substance is likely to contain a specification limit for the proportion of the methionine-oxidised variant. Methionine oxidation has no effect on...
Determination of the purity of valine by isocratic liquid chromatography coupled with charged aerosol detection (CAD) [0.03%]
等度液相色谱-电荷气溶胶检测器法测定缬氨酸纯度
A Lodi,M Angus,C J Nap et al.
A Lodi et al.
A liquid chromatography coupled with charged aerosol detection (LC-CAD) procedure; capable of separating and quantifying the most common impurities of valine at levels as low as 0.05 per cent (m/m), has been developed. The procedure is simp...
Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6 [0.03%]
人凝血因子ⅩⅢ中FS片段与CD59糖型分布及含量的多国比对研究项目报告
F Lackner,A Daas,E Terao
F Lackner
An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for the current European Pharmacopoeia (Ph. Eur.) prekallikr...
Normal temperature variation in New Zealand white rabbits during restraint for preliminary pyrogen test [0.03%]
新西兰白兔在初步热原试验中束缚应激时体温的变化
C Caldeira,J C B R Freitas,I Gimenes et al.
C Caldeira et al.
The in vivo pyrogen test is the main toxicological assay used in the quality control of injectable products, especially immunobiologicals. Pharmacopoeias state that, before the main test, a preliminary test must be conducted on all animals,...
Collaborative study for the recalibration of Ph. Eur. Heparin sodium BRP batch 3 for chromogenic potency assays [0.03%]
欧洲药典肝素钠BRP批号3的协同研究以进行色度法活力测定的再标定
A Daas,G Rautmann,E Terao
A Daas
Following the heparin adulteration crisis, the European Pharmacopoeia (Ph. Eur.) Group of Experts on Biologicals (Group 6) considered a revision of the general chapter 2.7.5. Assay of heparin with regard to the assay of the anticoagulant ac...
An HPLC method to determine sennoside A and sennoside B in Sennae fructus and Sennae folium [0.03%]
高效液相色谱法测定番泻果与叶中番泻苷A和B的方法研究
Immanuel Rosenthal,Evelyn Wolfram,Beat Meier
Immanuel Rosenthal
Introduction: The current Ph. Eur. monographs for senna pods, senna leaf and senna leaf dry extract standardised describe a photometric assay based on the Bornträger reaction to determine hydroxyanthracene glycosides, ca...
Validation and application of an HPLC-CAD-TOF/MS method for identification and quantification of pharmaceutical counterions [0.03%]
一种用于鉴定和定量药物反离子的HPLC-CAD-TOF/MS方法的验证与应用
D Ilko,C J Nap,U Holzgrabe et al.
D Ilko et al.
A generic approach for the analysis of counterions of pharmaceutical reference substances, which are established by the laboratory department of the European Pharmacopoeia (Ph. Eur.), was developed. A mixed-mode chromatography method using ...
Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3 [0.03%]
人免疫球蛋白电泳欧洲药典参考品批号3的协作研究
M-E Behr-Gross,A Daas,S Christians
M-E Behr-Gross
Due to the diminished stocks of the 2(nd) batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human immunoglobulin for electrophoresis, in 2013, the European Directorate for the Quality of Medicines and...