samedan logo

 
 
spacer
home > pmps > winter 2008 > pushing for purity
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Pushing for Purity

Traces of impurities in pharmaceutical products can have drastic consequences; Dr Christian Zeine at LGC Standards GmbH outlines the ways in which their presence can be controlled and prevented

Impurities are always present in drug products in trace quantities. Limit and threshold values are specified by official bodies and legislation such as pharmacopoeias and ICH guidelines. Dedicated reference standards for impurities can help in the development and validation of analytical methods for impurity control, and are also used in the routine analysis of drug products. The use of such standards can provide an accurate assessment of products against regulatory limits and thereby ensures appropriate onward actions, be these data submission, process improvement or preclinical evaluation.

TYPES OF IMPURITIES

According to the International Conference on Harmonization (ICH), impurities are defined as substances in the active pharmaceutical ingredient (API) that are not the API itself (1). For a pharmaceutical formulation (that is, a tablet or suppository), impurities are defined as substances in the product that are not the API itself, nor the excipient used to manufacture the relevant pharmaceutical (2). Investigations for their presence or absence are important due to their risk potential. Impurities can themselves be pharmacologically or toxicologically active and they can also reinforce or diminish the pharmacological efficacy of the API. Sometimes impurities may even be teratogenic, mutagenic or carcinogenic. Impurities can be divided into three categories: organic impurities, inorganic impurities and solvents.

Organic Impurities
These arise during production and/or storage of the API and can be starting materials, by-products or degradation products. Organic starting materials and by-products are removed as much as possible after the production through downstream processing of the API. Degradation products, however, cannot be removed from the finished product. Stability tests must be carried out to prove that such degradation products do not exceed certain limits during the product shelf-life. Those limits must have been previously defined and justified for each degradation product.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.


spacer
Dr Christian Zeine studied for a degree in Chemistry at the Westphalian Wilhelm-Universität Münster, where he also gained a PhD in 1998. This was followed with projects for pharmaceutical and in vitro diagnostics manufacturers including B. Brown Melsungen. Since 2002, he has worked as Pharmaceutical Reference Materials Product Manager with LGC Standards in Wesel, Germany
spacer
Dr Christian Zeine
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

FGK Representative Service opens new subsidiary in Ireland

In February 2021, FGK Representative Service Ireland Limited has been established to provide legal representation services for sponsor companies without subsidiary within the European Union planning to conduct clinical investigations with medical devices in this region.
More info >>

White Papers

Data Technology as a Catalyst for Growth in the Life Sciences

AIGENPULSE

The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement