Extractables from integrated single-use systems in biopharmaceutical manufacturing. Part I. Study on components (Pall Kleenpak connector and Kleenpak filter capsule) was written by Ding, Weibing;Nash, Rebecca. And the article was included in PDA Journal of Pharmaceutical Science and Technology in 2009.Product Details of 1190-39-2 This article mentions the following:
Single-use systems for manufacturing biopharmaceuticals can include filter capsules, connectors, tubing, and polymeric film biocontainers. In order to tackle the variety of extractable compounds from these fairly complex systems, we first studied such systems’ representative components, and then examined an entire single-use system comprised of filters, connectors, tubing, and biocontainers. This approach greatly simplifies the identification of the extractable compounds from the whole system. The test design was based on common, actual processes conducted under worst-case conditions. Part 1 of this series of papers describes a systematic study of extractables from two components, a sterile connector and a capsule filter, in water and ethanol as model solvent extractants. The complete extractables results were obtained using a combination of qualified anal. methods. The results indicated that the potential for the connector and the capsule filter to release leachable materials in significant amounts into the chem. compatible drug product is very low, taking into account the less vigorous conditions in most processes and dilution effects when compared to the water and ethanol extraction conditions reported here. Application of study results is discussed. In the experiment, the researchers used many compounds, for example, malonic acid dibutyl ester (cas: 1190-39-2Product Details of 1190-39-2).
malonic acid dibutyl ester (cas: 1190-39-2) belongs to esters. Carboxylic acid esters of low molecular weight are colourless, volatile liquids with pleasant odours, slightly soluble in water. Many esters have the potential for conformational isomerism, but they tend to adopt an s-cis (or Z) conformation rather than the s-trans (or E) alternative, due to a combination of hyperconjugation and dipole minimization effects. The preference for the Z conformation is influenced by the nature of the substituents and solvent, if present. Lactones with small rings are restricted to the s-trans (i.e. E) conformation due to their cyclic structure.Product Details of 1190-39-2
Referemce:
Ester – Wikipedia,
Ester – an overview | ScienceDirect Topics