With over 51 years of testing expertise and 5 state-of-the-art laboratories, we conduct accurate raw material testing within an environment of high compliance.
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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 (Accreditation # 80071), with many of the most common raw material tests included within our ISO Scope of Accreditation.
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.
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.