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Technical Guideline for Study of Nitrosamine Impurities in Chemical Drugs (Trial) was issued by the China National Medical Products Administration on 8 May 2020. This guideline discusses nitrosamine impurities in drug products, including the sources of nitrosamine impurities and the control strategy. The control strategy is given from the perspectives of the basic concept of control, control limits, establishment of analytical methods, and control of risk throughout the drug product lifecycle.
As nitrosamines are known as probable carcinogens, the marketing authorization holders and drug manufactures should take the responsibility to evaluate the risk by performing nitrosamine testing of API, excipients, and package system through the drug product shelf life using globally recognized test methods. The nitrosamine impurities level should be controlled below the acceptable limits based on compliance with ICH M7 (R1) [Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk] requirements.
As the world leader in the integrated containment and delivery of injectable medicines, West is well aware of the guidance concerning nitrosamines. Additionally, West closely monitors this issue and works to fully support customers with relevant information. For more regarding nitrosamine data in formulations, please contact a technical customer support (TCS) representative.
At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled <a href="-/media/8181C68A2AE940A2BB0FC816E642391A.ashx">Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle</a>. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.<br />
The two most common means of sterilizing elastomeric parenteral packaging components are steam autoclave and gamma irradiation processes. When appropriately validated, both processes are very effective at eliminating concerns around microbial contamination of the components used for container closure of sterile liquid, lyophilized or powder drug products. Despite the ability of both methods to reach the required sterilization specifications and requirements, the overall impact that these processes have on the elastomeric component can be quite different.
It is that time of year, Events season! West technical experts are out and about at all types of events around the world. Stop by at one of these events to learn what West products are all about and how we’re striving to be by your side for a healthier world.
Industry meetings continue to reinforce the changing landscape of the drug pipeline and the influence of biologic drug products in driving this change. At the recent DCAT Week, hosted by the Drug, Chemical and Associated Technologies Association, Josef Bossart, of PharmaCircle, provided an excellent overview of historic trends and current forecasts.
West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics <em>Pharmazeutische Packmittel</em> (Elastomeric Pharmaceutical Packaging).
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