Regulatory requirements for therapeutic proteins: the relationship between the conformation and biological activity of filgrastim [0.03%]
治疗性蛋白质的监管要求：filgrastim的构象及其生物活性之间的关系
A F Bristow,C Bird,B Bolgiano et al.
A F Bristow et al.
Higher order structure, including conformation, is considered a critical quality parameter of therapeutic proteins, and is mandatory information in development of first use and bio-similar therapeutic protein drugs, the assumption being tha...
Feasibility studies. The use of NMR spectrometry as a possible substitute of or complement to several analytical tests in pharmacopoeia monographs [0.03%]
可行性研究。核磁共振谱法有可能替代或补充药典各品种项下若干例行分析试验的方法学考察
I McEwen,T Arvidsson
I McEwen
NMR spectrometry has many analytical applications; for instance, the identification of known substances; the structure elucidation of unknown ones; the quantification of APIs, impurities, solvent and water; kinetic studies, stereochemistry ...
S Wyss,I A Werner
S Wyss
Gas chromatography (GC) is a powerful tool in the separation science of chiral analytes. The development of a new chiral test mixture for cyclodextrin (CD) coated GC columns allows comparing, choosing and identifying most suitable columns f...
Study of the risk of heavy metal transfer to homoeopathic mother tinctures [0.03%]
重金属向顺势疗法原液迁移的风险研究
J Busch,W Werner,A Huwer
J Busch
To assess the risk of heavy metal contamination of homoeopathic mother tinctures, 9 plant species and 1 fungus used in the manufacture of homoeopathic medicaments were investigated. Mother tinctures were prepared according to the manufactur...
J Busch,I Allmann,H Hölz et al.
J Busch et al.
Based on experimental results of aflatoxin analysis as well as information from literature, this contribution discusses the likelihood of aflatoxin contamination in fresh medicinal plants. As cultivation and collection of medicinal plants i...
Collaborative study for the establishment of the 3rd international standard for dihydrostreptomycin [0.03%]
地斯皮霉索第三国际标准的协作研究工作
G Rautmann,A Daas,K-H Buchheit
G Rautmann
An international collaborative study was organised to establish the World Health Organization (WHO) 3rd International Standard (IS) for dihydrostreptomycin. Eleven laboratories from different countries participated in the collaborative stud...
Calibration of the human immunoglobulin BRPs for ACA and molecular size (batch 1) and for Fc function and molecular size (batches 1 & 2) [0.03%]
人免疫球蛋白BRPs的校准用于ACA和分子大小（批次1）以及用于Fc功能和分子大小（批次1和2）
E Sandberg,A Costanzo,A Daas et al.
E Sandberg et al.
The current European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation batch 3 (BRP3) for Human Immunoglobulin was established in 2005. Stocks of this BRP are dwindling and a replacement batch is needed to serve as working standard ...