Low-level detection is the highly-sensitive type of testing that is utilized for analytes, which may be present in a material at a low-level. Low-level detection methods may be employed to test for compounds or elements which are desirable in a product such as microgram quantities of minerals or botanical extracts in dietary supplements, or undesirable, such as contaminants, impurities and degradants.
Undesirable analytes may be organic in nature such as 1,4-Dioxane or formaldehyde, or inorganic, such as arsenic or lead. 1,4-Dioxane finds its way into cosmetic and personal care products as a low-level contaminant in certain types of ingredients that are commonly used by the industry. These commonly used ingredients include certain detergents, foaming agents, emulsifiers and solvents identifiable by the prefix “PEG” (polyethylene glycol). 1,4-Dioxane may also be introduced into cosmetic and personal care products from processing aids and manufacturing equipment, such as hoses and gaskets.
As technology has improved, so has our ability to detect very low-level analytes in test materials. Some of the more important analytical tools in use today for low-level detection testing are ICP-MS, UPLC-MS and GC-MS.
Currently, there is much attention being focused on extractable and leachable compounds. These are contaminants that, with the advancement of low-level detection technology, have now been found in drugs and other types of products. Extractable and leachable contaminants typically find their way into products from raw materials, processing equipment or container and closure systems. As a result, low level-detection testing is now necessary for assessing the presence of extractable and leachable compounds within these possible sources and within the products themselves.
Low-level detection testing is of the utmost importance to manufacturers, product owners and consumers alike. Utilizing state-of-the-art technology such as ICP-MS, UPLC-MS, HPLC-MS and GC-MS, CPT℠ performs low-level detection testing on a daily basis for contaminants and many other analytes including sulfates, parabens and phthalates.
Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:
- Clinical — Efficacy trials can be performed for safety, consumer in-use, and to support claims, such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.
- In-Vitro Safety — Our in-vitro safety department assists clients when they are looking to perform non-animal or animal-free toxicology testing.
- Microbiology — Antibiotic testing for the pharmaceutical industry is routinely performed at CPTSM. We also perform other compendial assays for Microbial Content, Preservative Efficacy, Sterility, Bioburden, Water Activity and Specialty Microbiology Projects.
- Photobiology — From SPF and Water Resistant claims to Photo Allergy and Phototoxicity studies, CPT℠ is the world leader in sunscreen testing.
- Analytical Chemistry – From raw materials, batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our Analytical Chemistry Department ensures that all requirements are met based upon regulatory requirements and industry standards.