Nitrosamines, DEA, PFAS, and Pesticides Testing
- 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
CPT℠ proudly announces the acquisition of PerkinElmer QSight® 420 Triple Quad LC/MS/MS technology.
This “state-of-the-art” technology now enables CPT℠ to analyze the most challenging sample types at the highest level of sensitivity.
Although Triple Quad LC/MS/MS technology may be used in many testing applications, it provides a formidable tool for quantitating dangerous impurities or contaminants that may be present at extremely low levels in ingredients and product formulations. With this goal in mind, CPT℠ decided to add this technology to its arsenal of analytical firepower.
Nitrosamines
Nitrosamines are a structurally-related group of compounds, some of which have been identified as mutagenic carcinogens. Since nitrosamines have a long history of being found in cosmetic/personal care products and more recently in certain types of drug products, testing for the presence of nitrosamines is of the utmost importance.
CPT℠ currently tests for all seven (7) of the Nitrosamines identified in United States Pharmacopeia (USP) General Chapter <1469> “Nitrosamine Impurities” as follows:
- NDMA (Nitrosodimethylamine)
- NDEA (Nitrosodiethylamine)
- NDIPA (Nitrosodiisoproplyamine)
- NEIPA (Nitrosoethylisopropylamine)
- NDBA (Nitrosodibutylamine)
- NMPA (Nitrosomethylphenylamine)
- NMBA (Nitrosomethylaminobutyric acid)
CPT℠ also has the capability for testing seven (7) additional Nitrosamines not currently identified in the USP:
- NDELA (N-Nitrosodiethanolamine)
- NPIP (N-Nitrosopiperidine)
- NDPA (N-Nitrosodipropylamine)
- NNEA (N-Nitroso-N-ethylaniline)
- NDBzA (N-Nitrosodibenzylamine)
- NDIBA (N-Nitrosodiisobutylamine)
- NDTMHA (N-Nitroso-N, N-di(3,5,5-trimethylhexyl)amine
Whether you require USP General Chapter <1469> testing for Nitrosamine Impurities or a more complete screening for additional known nitrosamines, CPT℠’s analytical team equipped with our new PerkinElmer QSight® 420 Triple Quad LC/MS/MS is ready to assist, providing test results down to parts per billion (ppb) levels of individual nitrosamines.
Diethanolamine (DEA)
DEA has been identified as a possible human carcinogen. Since DEA is used in the production of many ingredients commonly used in cosmetics and shampoos, it is often found as a low-level contaminant in these products. CPT℠’s analytical Team, equipped with our new PerkinElmer QSight® 420 Triple Quad LC/MS/MS, is ready to assist, providing test results down to parts per billion (ppb) levels of DEA.
PFAS (Per- and Polyfluoroalkyl Substances)
PFAS are a diverse group (thousands) of human-made chemicals with a carbon-fluorine bond that generally resist grease, oil, water, and heat. They are used in a wide range of consumer and industrial products. Certain PFAS are intentionally added to products as ingredients, while others appear unintentionally as contaminants from raw materials, packaging components, the industrial process, the environment, or interactions with other PFAS within a formulation.
One common concern is that PFAS break down very slowly and can accumulate in humans, animals, and the environment over time, posing potential health risks. Exposure to certain PFAS has been associated with serious health effects.
FDA is currently concerned over the discovery of specific PFAS in food and cosmetic products. As a result, FDA has developed and validated an HPLC method for quantitating thirty (30) of the most common (and possibly most dangerous) PFAS found in the food and cosmetic products they tested. FDA’s method utilizes Triple Quad LC/MS/MS technology. CPT℠’s analytical Team equipped with our new PerkinElmer QSight® 420 Triple Quad LC/MS/MS is ready to assist in the screening for specific PFAS in your raw material and product formulations by employing FDA’s validated PFAS test method. This method has the capability of providing test results down to parts per billion (ppb) and even parts per trillion (ppt) levels of each of the specific PFAS identified and currently being monitored by FDA.
The thirty (30) PFAS analytes indicated in FDA’s validated test method which CPT℠ can test for:
- PFBA (Perfluorobutanoic acid)
- PFPeA (Perfluoropentanoic acid)
- PFHxA (Perfluorohexanoic acid)
- PFHpA (Perfluoroheptanoic acid)
- PFOA (Perfluorooctanoic acid)
- PFNA (Perfluorononanoic acid)
- PFDA (Perfluorodecanoic acid)
- PFUdA (Perfluoroundecanoic acid)
- PFDoA (Perfluorododecanoic acid)
- PFTrDA (Perfluorotridecanoic acid)
- PFTeDA (Perfluorotetradecanoic acid)
- PFBS (Perfluorobutanesulfonic acid)
- PFPeS (Perfluoropentanesulfonic acid)
- PFHxS (Perfluorohexanssulfonic acid)
- PFHpS (Perfluoroheptanesulfonic acid)
- PFOS (Perfluorooctanesulfonic acid)
- PFNS (Perfluorononanesulfonic acid)
- PFDS (Perfluorodecanesulfonic acid)
- PFUnDS (Perfluoroundecanesulfonic acid)
- PFDoS (Perfluorododecanesulfonic acid)
- PFTrDS (Perfluorotridecanesulfonic acid)
- PFOSA (Perfluorooctanesulfonic acid)
- HFPO-DA (Hexafluoropropylene oxide dimer acid
- DONA (4,8-Dioxa-3H-perfluorononanic acid)
- 9Cl-PF3ONS (9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid)
- 11Cl-PF3OUdS (11-chloroeicosafluoro-3-oxaundecane-1- sulfonic acid)
- 4:2 FTS (1H,1H, 2H, 2H-Perfluorohexane sulfonic acid)
- 6:2 FTS (1H,1H, 2H, 2H-Perfluorooctane sulfonic acid)
- 8:2 FTS (1H,1H, 2H, 2H-Perfluorodecane sulfonic acid)
- 10:2 FTS (1H,1H, 2H, 2H-Perfluorododecane sulfonic acid)
Pesticides
The presence of “banned” pesticides and/or “permitted” pesticides which exceed currently allowable limits in food, drug, and cosmetic products are always a concern to both USEPA and FDA. CPT℠’s new Triple Quad LC/MS/MS technology is a powerful tool when employed in testing for the presence of a multitude of pesticides. This is a new testing service that CPT℠ will soon be offering.
CPT℠ Can Help With Your Testing Needs
How can CPT℠ assist in testing for the presence of Nitrosamines, Diethanolamine, PFAS, Pesticides, and other dangerous contaminants?
CPT℠ has a long history of testing for trace levels of dangerous contaminants in ingredients and product formulations. With the addition of Triple Quad LC/MS/MS technology, the list of dangerous contaminants that CPT℠ can test for has grown significantly longer. Why not contact us today to discuss your contaminant testing needs?
