The purpose of purity testing is to fulfill the need for qualification and identification of any organic impurity that occurs in drug substances or drug products.
Impurities can originate from drug synthesis, manufacturing or storage. Through purity testing, a drug impurity profile, defined as 'a description of the identified and unidentified impurities present in a drug substance or drug product', is obtained.
During release activities, the quality of a drug substance or drug product with respect to impurities needs to be controlled to demonstrate compliance with specifications. Different batches of the same drug prepared in the same way could be expected to contain the same impurities. However, the relative concentrations of these impurities may show large variation, for example due to the nature of the starting materials.
To be able to establish a shelf life and label storage instruction of your drug product, you need to conduct stability studies. By stability testing, the impact of time and environmental factors (such as temperature and humidity) on the quality of a drug substance or drug product is evaluated. Purity testing is an important part of stability studies and requires stability-indicating methods.
We offer a systematic approach for the development of stability-indicating methods, which can separate, detect and quantify any impurity or degradation product. Traditionally, we use liquid chromatography, HPLC or UPLC, with gradient elution to obtain robust, accurate and sensitive methods. Integral part in each method are the system suitability tests, used to guarantee adequate performance of the chromatographic system throughout the analysis
In addition, we offer you impurity identification by mass spectrometry.
Anabiotec has a state of the art instrumentation platform, consisting of more than 20 HPLC and UPLC systems of different brands, all connected to a UV, PDA or MS detector.
Look no further! Anabiotec is the expert in purity testing. Contact our specialist who will answer all your questions with pleasure.
