Raw Materials Testing

Think of CPT℠ as an extension of your organization’s Quality Unit. With over 45 years of testing expertise and 5 state-of-the-art laboratories, we conduct accurate raw material testing within an environment of high compliance. What does this mean for you?

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What is Supply Chain Quality Management?

Active Pharmaceutical Ingredients (APIs), inactive ingredients (excipients), antimicrobial agents (preservatives) and processing aids all fall under the general heading of Raw Materials.   Raw Material testing is conducted for the purpose of verifying the suitability of purchased raw materials prior to their usage in product batches.

The assurance of product quality begins with Supply Chain Quality Management. This includes qualification of raw material vendors, validation of test results that vendors report on their raw material Certificates of Analysis, and a program of ongoing quality testing/monitoring for verifying the identity, strength, quality and purity of incoming raw materials.

Supply Chain Quality Management ensures a more efficient use of production resources and can eliminate batch rejections due to poor raw material quality.  Manufacturers of drugs and other therapeutic products are required to monitor the quality of the raw materials that are used in their products.

Though not currently required of cosmetic and personal care product manufacturers, many understand that monitoring the quality of raw materials makes good business sense and as a result, conduct raw material testing with the hope of reducing production delays, downtime, batch reworking, rejections and missed shipping dates.

CPT℠ is a qualified and experienced testing lab that ensures raw material analyses are conducted in strict accordance with compendial, client or in-house methodologies, and in full compliance with all applicable regulations.  Additionally, CPT℠ is ISO/IEC 17025:2017 accredited, with many of the most common raw material tests included within our ISO Scope of Accreditation.

What Raw Materials Do We Test?

CPT℠ has a long history of testing raw materials of all types, including but not limited to drug and dietary supplement active ingredients, botanical ingredients, preservatives, inactive ingredients, processing aids, solvents, polymeric resins and more. 

CPT℠ always recommends to its clients that wherever possible, official compendial methods be employed in the testing of raw materials. Where this is not possible, validated methods or those published in peer-reviewed literature are a suitable alternative.

Commonly Requested USP Raw Material Tests

This testing is conducted to confirm that if present, residual solvents do not exceed acceptable levels in raw materials.

This testing is conducted to confirm that if present, elemental impurities do not exceed acceptable levels in raw materials.

This testing is conducted to confirm that active ingredient and preservative raw materials are of the proper strength/potency, and that related compounds/impurities do not exceed acceptable levels.

The Major Instrumentation We Use for Raw Material Testing

  • High-Performance Liquid Chromatographs (HPLC) using UV, PDA, RI, Light Scattering and Fluorescence Detection.
  • Ultra-Performance Liquid Chromatographs (UPLC) using UV, PDA and MS Detection.
  • Gas Chromatographs (GC) using FID, MS, TCD and EC Detection.
  • Inductively Coupled Plasma (ICP) using either Mass Spectrometry (MS) or Optical Emission Spectroscopy (OES) detection.
  • Atomic Absorption/Graphite Furnace Spectrophotometers.
  • UV/Visible Spectrophotometer.
  • Fourier Transform Infrared (FTIR) Spectrophotometer.
  • Differential Scanning Calorimeter (DSC).

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Please Note: CPT℠ only performs testing for companies. We do not perform product testing for the general public.

CPT℠ is closed January 16, 2023 in observance of Martin Luther King, Jr. Day.
Normal business hours will resume on Tuesday, January 17th.