Impact of highly concentrated contaminants on the quality of oxygen 93 % produced by pressure swing adsorption [0.03%]
高压吸附法制备的医用氧气中高浓度痕量杂质的影响研究
K Züchner,U B Pflaum,I Meineke
K Züchner
A zeolite based pressure swing adsorption (PSA) module designed to produce medicinal oxygen with 90 - 96 % oxygen content was exposed to high input concentrations and high total amounts of CO (17.7 %, 44 mol), CO2 (16.5 %, 23 mol), NO2 (0.9...
Development and validation of a molecular size distribution method for polysaccharide vaccines [0.03%]
多糖疫苗分子大小分布方法的开发与验证
G Clément,J-F Dierick,C Lenfant et al.
G Clément et al.
Determination of the molecular size distribution of vaccine products by high performance size exclusion chromatography coupled to refractive index detection is important during the manufacturing process. Partial elution of high molecular we...
Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV) [0.03%]
人用口服轮状病毒减毒活疫苗生产用欧洲药典菌种BRP-4标定报告书
L Fiore,A De Dominicis,A Daas et al.
L Fiore et al.
Poliomyelitis (polio) is a highly infectious disease that affects mostly young children and which may lead to paralysis and death. Prevalence of polio has considerably decreased. However, the effort of global eradication through immunisatio...
Collaborative study for the establishment of the 2nd international standard for neomycin B [0.03%]
制备.neo明B第二国际标准品的协作研究
S Jorajuria,C Raphalen,V Dujardin et al.
S Jorajuria et al.
An international collaborative study was organised to establish the World Health Organization (WHO) 2nd International Standard (IS) for neomycin B. Seven laboratories from different countries participated. Potencies of the candidate materia...
Collaborative study for the establishment of the 3rd international standard for neomycin [0.03%]
硫酸新霉素国际参考标准第三号协作研究
G Rautmann,A Daas,K-H Buchheit
G Rautmann
An international collaborative study was organised to establish the World Health Organization (WHO) 3(rd) International Standard (IS) for neomycin. Ten laboratories from different countries participated in the collaborative study. The poten...
Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines [0.03%]
一种新的体外测定甲型肝炎免疫球蛋白和疫苗效力的酶联免疫吸附试验的方法学研究
S Morgeaux,P Variot,A Daas et al.
S Morgeaux et al.
The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of hepatitis A virus antigen content in hepatitis A vaccines (HAV) marketed in Europe. This became necessa...
The occurrence of bromide in herbal drugs: is there a need for a Ph. Eur. limit? [0.03%]
药用植物中溴化物的出现：是否有必要制定欧洲药典限值？
H Albert,J Busch,B Klier et al.
H Albert et al.
This contribution provides an overview on the current legal requirements regarding limits for bromide and presents data on the actual bromide burden of commonly used herbal drugs. Evaluation of an extensive data base shows that results exce...
International collaborative study for the calibration of the Ph. Eur. somatropin chemical reference substance batches 3 and 4 (BSP108) [0.03%]
人促生长素化学参考物(BSP108)国际协作标化研究
M Girard,G Rautmann,B Lorbetskie et al.
M Girard et al.
An international collaborative study was carried out for the establishment of replacement batches for the European Pharmacopoeia (Ph. Eur.) Somatropin Chemical Reference Substance (CRS) batch 2. The study was organised within the framework ...
On the formation of bromhexine impurity E and its chromatographic behaviour [0.03%]
关于溴己新杂质E的生成及色谱行为研究
B J Venhuis,M Weda,D de Kaste et al.
B J Venhuis et al.
An unknown bromhexine hydrochloride (BRH) degradation product in BRH oral solutions (finished products) was potentially related to the purity of this API. Several degradation experiments were conducted and its identity and formation were in...
Establishment of recombinant major allergens Bet v 1 and Phl p 5a as Ph. Eur. reference standards and validation of ELISA methods for their measurement. Results from feasibility studies [0.03%]
花粉主要过敏原Bet v 1和Phl p 5a的重组参考品建立及其定量ELISA方法验证的研究课题成果
S Vieths,D Barber,M Chapman et al.
S Vieths et al.
The potency of allergen extracts is determined as total allergenic activity without consideration of their composition and the units differ from one manufacturer to another, making it very difficult to compare the different products. Recent...