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Deconstructing crucial questions regarding pharma impurities standards today

importance of quality and risk management for drugs



There is a crucial requirement to follow best practices regarding pharma impurities. It relates to organic or inorganic substance presence while profiling the products. The measurement of drug impurity standards is defined through residual solvents or organic/inorganic material traces. The reasons range from chemical reactions to ingredients and resulting synthesis. It is important to consider usp impurity standards to measure APIs. There are exclusive companies that handle such cases for the pharma industry.


SimSon Pharma Limited is one of the reliable impurities suppliers in India fulfilling all criteria related to quality and risk management for drug formulations. It is in the business of tracing potential impurities and assists drug makers to reduce its harmful aspects. 


This blog opens up on our active participation to deconstruct crucial questions related to pharma impurities standards.

A reference standard relates to:


·         Purity of the material of chemical, medical and pharma products

·         Characterized to suitability for formulation

·         Passes tests for identity, strength, quality and purity of the substances

·         Reference standards are derived from USP or in-house.


They are important in the entire drug making process for safety and end consumption.


Why is impurity profiling mandatory by regulatory authorities?


In order to meet the reference standards, the profiling consists of measuring:


·         Identification

·         Structure elucidation

·         Quantitative determination of impurities

·         Degradation in bulk drug materials

·         Pharm formulation


The regulatory authorities that are involved include:

·         ICH

·         USD FDA

·         Canadian Drug and health agency


Checking for impurities today is important to ensure that no toxic material is present in the drugs which potentially can be harmful. At the formulation stage they are detected to avoid problems with finished products. This ensures that the product is of good quality and safe to use. This calls for quality and risk management for drugs which are produced by various companies.


The usp impurity standards are different from other reference standards. To ensure quality in developing and the entire manufacturing process, this standard is required. Many independent labs are involved in the testing procedure. This important procedure guarantees value beyond the vial. USP is now the leading standard across the world.


Its benefits to generic drug makers are visible due to:


1.      Acceleration of development process and better analytical methods.

2.      Mitigating the ANDA rejections by use of pharmacopeial products by FDA.

3.      Off-patent drugs benefit all patients.

4.      Better compliances for safe usage of drugs for long term.

5.      Minimizes lab risks with better management.

6.      Save time and resources to achieve results faster.


It is important to use the right reference standard for measurement of impurities. A knowledge company assures pharma clients of the best services and practices at reasonable rates.


If you would like to know more about how we conduct the processes and adhere to the reference standards, please visit our website or talk to us. As impurities suppliers in India, our company is known to follow ICH guidelines which refer to Q3A (R), Q3B (R), and Q3C.

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