It is necessary to assure that the observed pharmacologic or toxicological effects of a drug substance or Drug product are truly due to the compound of interest and not due to impurities. Furthermore, it is also important to ensure that the product formulated for marketing does not generate any impurities during its shelf life that would cause deleterious effects.
The control of these impurities is currently a critical issue in the Pharmaceutical Industry these days and it is necessary to incorporate stringent tests to control the impurities arising from different sources. The different sources from where the impurities may arise are:
- The raw material used in the synthesis
- During the route of synthesis
- Contaminants from the atmosphere
- Product instability
A well-accepted fact is that some of the impurities are unavoidable and may remain in the drug substance in trace amounts. Now, the main questions arise “HOW TO IDENTIFY THESE IMPURITIES”? and “WHAT IS THE SPECIFICATION LIMIT OF THESE UNAVOIDABLE IMPURITIES”?
To answer the later, International Conference on Harmonization comes into the picture with its guidelines and policies which establishes the specification limits, evaluations, and control of impurities.
Definition : Impurity Profiling is a common terminology given to a group of analytical activities which aims at the following requirements:
- Structure Elucidation
- Quantitative determination of all the organic and inorganic impurities as well as residual solvents in raw material and formulated drug.
Importance : Since many impurities are derived from or closely related to the API, they may have pharmacological effects, which can reinforce or decrease product efficacy, or can even have toxic effects on patients taking the product.
Also, the impurity profile often depends upon the method of synthesis and the environmental conditions, the type, number, and volume of impurities present will typically vary between batches.
It is crucial, therefore, to monitor the product impurity profile which also allows companies to reduce long-term risks by optimizing reaction conditions so that impurities will not form in the first place.
Experts in Impurity Profiling : Outsourcing for research is the call of the hour for most Pharmaceutical companies. But, finding a trusted partner is a tedious task.
Pharmaffiliates Analytics and Synthetics Pvt. Ltd., a trusted partner for outsourcing globally ensure its clients to fulfill their requirements in a cost-effective and time-bound manner.
Research and Development team at Pharmaffiliates meticulously works on the impurity profiling of a product in our state of the art research laboratories.
The main R & D center of Pharmaffiliates is located in Panchkula (Haryana) with five labs . Whereas, Pharmaffiliates extends its arms towards Hyderabad with a capacity of another four labs making a total of nine research labs.
With a core team of almost 10 P.hD guides and a total of almost 250 associates, Pharmaffiliates lends its association with major Pharmaceutical giants across 65 nations.
The scientist and associates at Pharmaffiliates identify, isolates, elucidates and characterizes all the known and unknown impurities of a drug substance and today we have a total number of 60,000 impurities which includes API's, Metabolites, Glucuronides, Chiral standards, Intermediates, Stable isotopes and many more. More than 10,000 of these impurities are readily available in stock and can be readily dispatched. Rest of the products can also be made available at Pharmaffiliates in not much time.
The pack sizes we provide of 25, 50 and 100mg but since Pharmaffiliates is a customer-friendly firm, we can also customize them as per your need.
Apart from Impurity Profiling we also provide othera Research Based Organization services, the details of which can be seen by visiting our website www.pharmaffiliates.com