Raw Materials

Pharmaceutical testing for raw material
Pharmaceutical testing for raw material

We are the leading pharmaceutical testing lab in India with over 25 years of experience in the analysis of raw materials and finished products. We offer a complete solution for testing of pharmaceutical raw materials including pharmaceutical drug substances, intermediates, excipients et cetera.

Our years of experience in chemical testing, physical characterization, and microbiological analysis as per pharmacopoeial requirements help you face these challenges of capacities and capabilities.

Given below is a list of some of the most common test that we carry out for pharmaceutical raw materials using either pharmacopoeial, client or in-house methods –

  • Assay
  • Impurities and Related Substances
  • Residual Solvents and Organic Volatile Impurities
  • Identification tests by FTIR, chemical analysis et cetera
  • Limit tests for heavy metals by chemical methods or by ICP or ICP MS as per US 232, 233
  • Microbial limit tests
  • Sterility testing
  • Microbiological assays
  • Particle size distribution by optical microscopy
  • Particle size distribution by laser diffraction particle size analyser – Malvern
  • Test for crystallinity
  • Melting point
  • Differential scanning calorimetry (DSC)
  • X-ray diffraction (XRD)
  • Nuclear Magnetic Resonance (NMR)
  • and many more tests

The pharmaceutical industry uses a very large variety of raw materials and literally hundreds of ingredients can go into the manufacturing of a single product. It is often difficult if not impossible for a pharmaceutical manufacturer to have in-house testing facilities and capabilities for all the ingredients and products.

Even if all the facilities are available in-house invariably there is a pressure on the capacity available and it is essential to have a trusted partner who can carry out the testing of pharmaceutical raw materials before they can be released and used for manufacturing of the pharmaceutical products.

Besides routine analysis for release testing of pharmaceutical raw materials we also carry out method validation and development studies for all of these tests.

Our laboratories have also supported numerous manufacturers of pharmaceutical raw materials for carrying out stability is for their pharmaceutical drug substances and excipients.

Our laboratories are approved by the State Food and Drug Administration (FDA) and also by the Central Drugs Standards Control Organisation and we can provide reports on Form 39 as per the requirements of the Drugs and Cosmetics Act. We have approved laboratories in New Delhi, Himachal Pradesh, Bangalore.

Our laboratories in Delhi and Himachal Pradesh are also accredited by the National accreditation board for testing and calibration laboratories to the ISO standard 17025.

You can contact us now using the quick query form on the right or you can call us directly on +91 – 11 – 45754575 and our team will be happy to provide you a quotation and proposal for your pharmaceutical raw material testing requirements.

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