Low-Level Detection and Claims Testing

Low-Level Detection and Claims Testing

Cosmetics, supplements, food products and pharmaceuticals are required by law to meet particular standards as outlined by the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labeling Act. Manufacturers and distributors are obligated to ensure that such products marketed in the United States—regardless of manufacture origin—are unadulterated and appropriately labeled to communicate the identity and quantity of product contents. As such, low-level detection testing is of particular interest in product areas where “free from” claims are desired and/or where there is concern about product contamination by inadvertent impurity exposure. While pharmaceutical manufacturers are required to prove lack of adulteration prior to market introduction, no such requirements exist for cosmetics and food products. These products, however, are subject to market sampling by regulatory agencies and insufficient or incorrect product labeling could be a costly mistake. Thus, it is in manufacturers’ best interest to assess product quality prior to market entry to ensure regulatory adherence and support product claims.

Our Low-Level Detection and Claims Testing Capabilities

CPT^SM Labs has over 40 years of experience in consumer product testing and regulatory compliance evaluations for multiple industries including, but not limited to: pharmaceuticals, OTC drugs, consumer healthcare products, cosmetic and personal care products, specialty chemical, and medical device industries. Our seasoned analytical specialists are highly knowledgeable in validated, product quality evaluation methods and regulatory stability requirements.

CPT^SM performs low-level detection and claims testing according to validated, compendial methods outlined by USP guidelines and regulatory guidelines.

Common Low-Level Detection and Claims Analyses

1. Heavy Metals

Heavy metals are commonly defined as a group of elemental impurities that may pose health risks. Commonly evaluated heavy metals include arsenic, cadmium, lead, mercury, and antimony. These elements are ubiquitous in nature and readily detectable in soils and water. Heavy metals are frequently detected in the product raw materials as well as finished products and may be present in different chemical forms. Trace amounts of heavy metal impurities are considered unavoidable, but manufacturers can monitor and control their presence in the production process and final product itself using a risk-based strategy. For pharmaceutical applications, the acceptable levels of heavy metal contamination are dictated by the drug’s exposure route and dosage. As such, pharmaceutical manufacturers need to know the final heavy metal content of a product to ensure that it meets safety specifications. Cosmetic and food products should also be evaluated for heavy metal content. Analytical methods like inductively coupled plasma mass spectrometry (ICP-MS) are routinely used to identify and quantify chemical species in product formulations to confirm quality standards.

2. Extractables and Leachables

Extractables are substances that a patient may be exposed to while using a pharmaceutical product, while leachables are substances that patients are actually exposed to while using said product. Migration of extractable and leachable materials is of particular concern for pharmaceuticals that are administered via oral, inhaled, and parenteral routes as well as in medical devices and single-use systems (SUS) such as filters, tubing, and process containers. Detection of extractables and leachables is typically achieved through multiple quantitative and qualitative analytical methods including, but not limited to, Gas chromatography–mass spectrometry (GC-MS), conductivity tests, and total organic carbon (TOC) assays.

3. “Paraben-Free” Claims

Parabens are a class of chemicals that are often used in combination to prevent harmful bacteria and mold growth in products. Parabens like methylparaben and propylparaben are commonly featured in cosmetic products, though similar parabens may be included in food and pharmaceutical products. While limited paraben exposure is considered to not pose a threat to human health, some consumers are concerned about cumulative paraben exposure and wish to minimize paraben exposure where possible. “Paraben-free” product formulations can be verified by a variety of analytical methods such as High-performance liquid chromatography (HPLC) to confirm that parabens are not detected in the product or detected at very low levels.

4. “Gluten-Free” Claims

Gluten refers to the proteins found in cereal grains—notably wheat—and is known to cause illness in those with gluten sensitivity and celiac disease. Gluten-free claims are predominately used by food products to demonstrate product suitability for consumers who are interested in avoiding foods continuing gluten or foods that may have been exposed to gluten during processing and manufacture. Products bearing a gluten-free label must possess a gluten content no higher than 20 ppm. As with paraben-free analysis, gluten content may be measured via a variety of analytical methods like those discussed previously.

About CPT

With over 40 years of experience consumer product testing and regulatory compliance, CPT^SM Labs is well-positioned to be an extension of your Quality Assurance team. We provide expertise in multiple industries including pharmaceuticals, OTC drugs, consumer healthcare products, cosmetic and personal care products, specialty chemical and medical device industries. Our seasoned professionals are well-versed in technical knowledge associated with the FDA, EPA and international consumer product regulations. All testing is accurately and appropriately conducted according to compendial and validated standards. We aim to best suit our clients’ needs and strongly adhere to Good Laboratory Practices (GLP), GMP and Good Clinical Practices (GCP) standards. Customized testing programs and flexible turn-around times are available. Contact us at your earliest convenience.