Raw Material and Product Testing

Before a pharmaceutical, over-the-counter (OTC), medical device or nutritional product enters the market, it must undergo a series of extensive tests to ensure​ it complies with regulatory requirements and standards.

This testing is critical for our clients to demonstrate quality, efficacy, and safety for the general public.

Our in-house experts can provide one-on-one guidance to help navigate the regulatory and compendial requirements for introducing new products to the market.

The BRS team has over 60 years of experience in the pharmaceutical industry and our team has a well-established track record of successful ANDA, NDA, IND, and PAS submissions.

Whether you require raw material, assay, preservative, stability or finished product testing, BRS can assist you with your analytical testing needs.

BRS employs both qualitative and quanitative methods for raw material and finished product testing.

  • Qualitative methods are used to identify a compound or verify the presence/absence of a specific compound.

  • Quantitative methods are used to determine the assay or amount of a particular analyte in a sample.

BRS offers the following testing services

  • USP, EP, JP, BP Compendia

  • Vendor Methods

  • Classical Wet Chemistry


The entire BRS team is made up of chemists who have been trained in the classical techniques which is, unfortunately, becoming a lost art in many laboratories.


Our PhD chemist led team has a wealth of experience in the preparation and work-up of samples which require a high level of skill and lab savviness.

Instrumental Wet Chemistry

Both qualitative and quantitative methods can be performed using laboratory equipment such as pH meters, automatic titrators (Karl Fischer), FTIR and UV/VIS spectrophotometers.

Some of our wet chemistry services include the following:

  • Limit Tests

  • Presence/Absence Tests

  • pH

  • Loss on Drying

  • Identification

  • Thin Layer Chromatography

  • Residue on Ignition

  • Viscosity

  • Distillations

  • Titrations

  • Bulk Density

  • Melting Range

  • Color Testing

  • Sieve Analysis

  • Conductivity

  • Container/Closure Performance Testing


If you need an extraction, titration, thin layer chromatography (TLC) or an induced chemical reaction, BRS can assist you.


Our team uses the most current methodologies and instrumentation to get you the results you need!


All testing is performed accurately under the strictest adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

 

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