Low-Level Detection

  • FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
  • DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
  • US EPA/NJ DEP Registration# NJD982726648
  • ISO/IEC 17025:2017 Accreditation# 80071

Low-level detection is a highly-sensitive type of testing that is utilized for elements and chemical compounds which may be present in a material at a low level. Low-level detection methods are employed to test for desirable analytes which are intentionally added to products, or undesirable analytes which are unintentionally added such as contaminants, impurities or degradants.

Organic vs. Inorganic Analytes

Examples of desirable low-level analytes include microgram quantities of minerals or botanical extracts that are added to dietary supplements. Examples of undesirable analytes include 1,4-Dioxane, Formaldehyde, Mercury, Lead, Benzene or Methanol.

As technology has improved, so has our ability to detect low-level analytes which may be present in ingredients, products, and plastic container systems. Some of the more important analytical tools in use today for low-level detection testing are ICP-MS (metals testing), UPLC-MS and LC-MS-MS (organic contaminants/impurities), and GC-MS (residual solvents and other volatile organic contaminants).

Extractables and Leachables

Currently, much attention is focused on Extractable and Leachable (E&L) testing for compounds which originate from plastic container systems and migrate into the products they contain. As a result, low-level testing for E&Ls is now required for plastic packaging systems (Extractables) and the drug products that they contain (Leachables). E&L testing commonly includes analytes such as heavy metals, organic contaminants and impurities .

Why Partner with CPT℠

Low-level detection testing is of the utmost importance to manufacturers, brands, and consumers alike. Utilizing state-of-the-art technology such as ICP-MS, UPLC-MS, LC-MS-MS, and GC-MS, the experts at CPT℠ conduct low-level detection testing on a daily basis for both desirable and undesirable low-level analytes.

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