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Identifying and controlling impurities in API formulation

Services of the right vendor for drug impurity standards

 

It is important to detect and understand any impurity profile related to API and formulation. It is the basis of ensuring that the drug production is safe and can be marketed on time. The pharma sector has plenty of expectations from the vendor and a few selected ones meet the drug impurity standards.

 

SimSon Pharma has been in the business of controlling impurities through very stringent methods. Our company follows all the necessary protocols and other usp impurities standards to gain reliability in our processes. We conform to the ICH Q3A (R2) expectations and thresholds.

 

The following informative content is designed for companies who look for trusted impurity standards suppliers in India to complete their projects.

 

 Isolation of impurity profile  

SimSon Pharma does not conduct trials related to samples only to apply the usp impurity standards and to meet the quality deadlines. It is important also to make business sense to the customer who has invested in the production and API formulation. As impurities suppliers in India, it is our duty to keep a check and monitor the processes. Impurities of any kind have negative consequences at any stage of drug production and its development.

 

The bad effects include: 

·         Complication of the formulation.

·         Increase in the reaction time to develop the drug

·         Due to degeneration, the product shelf life is limited. It expires faster due to the Contamination in the synthesis.

·         Even at a limited level, any impurity can become a health hazard for the patient.

·         It does not make business sense to reject batches once they are developed.

·         Unless companies choose the right impurity synthesis companies in India, the possibilities of undetected impurities can be dangerous.

 SimSon takes proactive steps to assist the drug development. When you approach us for conducting trials and identifying the complex structures of the profiles sent to our labs.


The most important steps we take are:

  •  Evaluating the levels of impurities.
  •             Trails begin by minimizing via synthesis and manufacturing.
  •           Recognizing the key structures that make impurities.
  •           Toxicity levels are qualified.
  •           Process of isolation and synthesis.
  •           Monitoring the API & DPs to distinguish deterioration of the products.

 

When you choose us for these critical processes, you can save on cost and time. Often problems even crop up during the trial stages and we can adopt diverse methods of handling with the correct drug impurity standards. Our chemistry teams will try to understand the customer’s short and long-term goals. It enables us to understand the level of flexibility required to meet the objectives in a timely manner. We have advanced level of instruments to detect high masses of impurities, which can be done in a matter of hours.  Whether you need us to control the upstream of impurities or make synthesis through the lab we have it all.

 

SimSon Pharma has years of research and is closely connected to the regulatory authorities to help customers to achieve their targets on time. We keep tracks of new mass spectrometry and technology to serve our global clients. Let us know about your project and we can provide a free consultation at your time.



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