Establishment of hepatitis A detection antibodies set BRR batch 3 for antigen content determination by ELISA [0.03%]
ELISA法建立第三批乙型肝炎病毒检测抗原测定国家参考品标定工作的报告
S Morgeaux,I Manniam,P Variot et al.
S Morgeaux et al.
The current batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Reagents (BRRs) used for the in vitro potency assay of hepatitis A vaccines (HAV) by ELISA (enzymelinked immunosorbent assay) was established in 2012 for use in...
Collaborative study for the establishment of the 2(nd) International Standard for Bleomycin Complex A2/B2 [0.03%]
制备bleomycin 复合物A2/B2第二个国际标准的协作研究
S Jorajuria,C Raphalen,V Dujardin et al.
S Jorajuria et al.
Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organism...
Collaborative study for the establishment of the 4(th) International Standard for Streptomycin [0.03%]
硫酸链霉素第四国际标准的协作研究
S Jorajuria,C Raphalen,V Dujardin et al.
S Jorajuria et al.
An international collaborative study was organised to establish the 4(th) World Health Organization (WHO) International Standard (IS) for Streptomycin. Fourteen laboratories from different countries participated. Potencies of the candidate ...
Establishment of the human albumin for electrophoresis Ph. Eur. BRP batches 3 and 4 [0.03%]
人血清白蛋白（Ph. Eur. BRP批号3和4）的建立
M-E Behr-Gross,A Daas,A Eulig-Wien et al.
M-E Behr-Gross et al.
Due to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human albumin for electrophoresis, the European Directorate for the Quality of Medicines & HealthCare (EDQM) i...
Rationale for the update of the European Pharmacopoeia general chapter 2.2.48. Raman spectroscopy [0.03%]
欧洲药典通用章节2.2.48拉曼光谱法修订理由
I R Lynch,W Schuh,W Kessler
I R Lynch
Raman spectroscopy technique is widely used for the identification and characterisation of materials in the laboratory environment and, increasingly, for off-line, at-line, in-line and online Process Analytical Technologies (PAT) applicatio...
The heavy metals cadmium, lead and mercury in raw materials of animal origin: evaluation of data from practice [0.03%]
动物源性原料中的镉、铅和汞等重金属：实践数据评估
J Busch,M Knödler,M Kühn et al.
J Busch et al.
Raw materials from animal origin are widely used in homoeopathy. Due to the lack of dedicated limits, the quality requirements for herbal drugs of the European Pharmacopoeia (Ph. Eur.) and/or the German Homoeopathic Pharmacopoeia (Homöopat...
B Klier,M Knödler,J Peschke et al.
B Klier et al.
In the context of a revision of the European Pharmacopoeia (Ph. Eur.) general monograph Essential oils (2098), the need to include a test for pesticides is being discussed. According to published literature, some oils, mainly those produced...
Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3 [0.03%]
乙型肝炎疫苗（汉逊酵母）BRP批2和3的建立
S Morgeaux,I Manniam,P Variot et al.
S Morgeaux et al.
The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 As...
Establishment of the Ph. Eur. erythropoietin chemical reference substance batch 1 [0.03%]
人促红素化学参考物第1批（Ph. Eur.）的确立
C Burns,A F Bristow,K H Buchheit et al.
C Burns et al.
The Erythropoietin (EPO) European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 was calibrated in 2006 by in vivo bioassay and was used as a reference preparation for these assays as well as for the physicochemical...
Collaborative study for the establishment of the WHO 3(rd) International Standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354 [0.03%]
人内毒素WHO第三国际标准、Ph. Eur.第五批生物参考品和USP内毒素H0K354菌株相对生物活性的国际合作研究
L Findlay,T Desai,A Heath et al.
L Findlay et al.
An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United States Pharmacopeia (USP) and the European Directorate for the Qua...