Quality Factors for Active Pharmaceutical Ingredients

Quality Factors for Active Pharmaceutical Ingredients

The superiority of an active pharmaceutical ingredient or API has a great consequence on the efficiency and safety of a medication. API is the central component of any medicine, and there may be medicines that need more than 1 API to be present. The composition of the API determines the type of drug being manufactured. API represented a USD 121 billion market in 2016, and is expected to reach nearly USD 200 billion by 2022. The quality requirements of an API or active substance helps the manufacturer to determine the use of the ingredient and the permissible limit of usage.

There are multiple aspects of manufacturing a medicine that all top pharmaceutical companies in India must bear in mind. This not only affects the use, but also the distribution of the medicine to a large extent.

The quality requirements of the API facilitates the manufacturer to understand the 3 main aspects about APIs, i.e. Physical, Chemical and Biological properties that can be used in the treatment of different ailments.

  • Chemical Factors: All chemical combinations can lead to impurities, in any form, either from active substances or from solvents. Manufacturers must be mindful of the potency of the ingredient used, the solvents used during mixing, etc., to determine the type of drug that being manufactured.
  • Physical Factors: The physical factors, i.e. particle proportion and polymorphism of an API, are quite critical to its suitability for drug use, as these may affect the flow of properties of the API, rate of absorption of the medicine, bioavailability of the drug since the particle size used in the API is very important, among others. All these factors ensure correct solubilisation of the drug in the body.
  • Biological Factors: The manufacturer also has to ensure that the API’s being used are clean-to-use in non-sterile dosage formulas, has low bio weight, free from toxins that may arise from dead microorganisms, etc.


Medicines or drugs have certain prescribed limits of active substances that are important to differentiate its usage and dosage. Medicines are known by their chemical composition as well as their physical name, depending on who is reading it. Different types of classifications of medicines are:

  • Antibiotics
  • Analgesics
  • Vaccines
  • Antimalarial
  • Antidepressants
  • Cardiac drugs
  • Anaesthetics, etc.


The chemical, physical and biological compositions are crucial quality factors for APIs that determine its usage. Along with this, all top pharmaceutical companies in India also have to be careful about packing, labelling, production, etc., that plays an equally important role. The Indian pharmaceutical market size is expected to grow to USD 100 billion by 2025, which means the quality of APIs also needs to be extremely high to be able to meet the requirements efficiently.

Disclaimer This blog solely intended for the educational/informational/awareness purposes and is not a substitute for any professional medical advice, diagnosis or treatment. Please consult your doctor/healthcare professional before acting on the information provided on the blog. Reliance on any or all information provided in the blog, is solely at your own risk and responsibility. Mankind Pharma Limited shall not be held liable, in any circumstance whatsoever.

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