Pharmaceuticals Testing
According to the FDA, the pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertains to the quality control laboratory and product testing. Therefore, the laboratory you choose can make a huge difference in helping you get market approval for new products, avoiding costly delays in submissions, approvals, recalls or interruptions in manufacturing.
NJ Labs has expertise across a wide range of testing for the pharmaceutical industry, with an eye towards trends that are becoming more of an issue with the FDA. A recent example is that of Suitability testing, which determines the ability of test methods to detect the presence of microorganisms in products that may be inherently antimicrobial. Another example is that regulations for heavy metals testing (Pb-Lead, As-Arsenic, Cd-Cadmium, Hg-Mercury) are now required to be done by USP<233> which is ICP-MS rather than more traditional wet chemistry methods. We also have the expertise for Fatty Acid profiles for oils as many pharma companies use fatty oils as fillers or bonding agents like Polysorbate 60, 80 and many more. Our assays of APIs and Finished drug products use a compendial method, confirming the ability to produce reliable and reproducible results by USP <1225> and USP <1226> and the list goes on…
Our goal is to help our clients avoid Deficiency Letters by anticipating issues of concern to the FDA. However, if you have received an FDA Deficiency Letter and need help addressing the issues raised, please reach out to us. We have helped many clients test for the deficiencies identified by the FDA, and provide responsive reports addressing the deficiency letters within the required timeframe.
CBD / Cannabidiol Testing
New Jersey Laboratories offers analytical testing following USP, FCC, and in-house methods, as well as any proprietary methods requested and provided to us by our clients. If you require custom methods, we will work with you to create a method that suits your needs.
Quality Cannabis testing that will stand-up to FDA scrutiny… Make no mistake, CBD means “blunt” business for companies looking bring new cannabis products to market. As legalization of cannabis for medicinal and recreational purposes continues state-by-state across the USA, the FDA is paying even closer attention to a myriad of CBD products being designed to meet a market demand of “perceived” health benefits by consumers.
NJ Labs is uniquely positioned to partner with cannabis companies because we are FDA, DEA, registered & inspected and have been entrusted with handling-controlled substances for years. As such, we understand the regulatory environment and will help you maintain transparency with your product. For example, we will provide you with proper scientific knowledge about the cannabinoid profile of your product as cannabis contains more than 80 active chemical compounds. We will also prove your product purity by deploying USP-like quality methodologies for cannabis testing.
Nutraceuticals Testing
Given the current state of the industry, it has never been more necessary to precisely identify the ingredients in Nutraceutical & Dietary supplements that as the saying goes: make you into what you eat. With FDA regulation looming, Nutraceuticals & Dietary Supplements testing will need to become even more analogous to the kind of quality testing currently being performed for pharmaceuticals; especially in an environment where an FDA mandated product registry for dietary supplements is being debated. Indeed, with new product categories appearing such as CBD oils and natural supplement Omega-3 alternatives vs. pharmaceutical grade Omega-3 drugs, the lines now are clearly blurred.
Given the current state of the industry, it has never been more necessary to precisely identify the ingredients in Nutraceutical & Dietary supplements that as the saying goes: make you into what you eat. With FDA regulation looming, Nutraceuticals & Dietary Supplements testing will need to become even more analogous to the kind of quality testing currently being performed for pharmaceuticals; especially in an environment where an FDA mandated product registry for dietary supplements is being debated. Indeed, with new product categories appearing such as CBD oils and natural supplement Omega-3 alternatives vs. pharmaceutical grade Omega-3 drugs, the lines now are clearly blurred.
NJ Labs’ scientists have the know-how and experience to overcome such challenges. Typically, we perform Preparatory Testing on Nutraceutical & Dietary Supplements which are like the Suitability Tests performed in the Pharmaceutical world. Our Preparatory testing establishes the procedures that would be used for routine testing of the same product — like a gateway test for a gateway drug. Additionally, creating testing methods for Dietary Supplements is a complex undertaking due to numerous inconsistencies from different sources.
For example, countries can produce the same botanical, but each can vary in terms of potency, impurities, and efficacy. We have the niche expertise required to properly analyze variances in raw materials and finished products with minimal method development.
Cosmetic Testing
As new product formulations in the cosmetics industry continue to be introduced very quickly, one of the biggest challenges manufacturers face is keeping up with current consumer trends while proving to government regulating bodies that product claims are substantiated with robust testing.
For cosmetics manufacturers, thorough testing not only of finished products but also the ingredients must become the priority. NJ Labs has the ability to perform Chemistry and Microbiological tests for cosmetics with a specialization in ingredient testing including: Vitamins: A, C, E, Panthenol, Alpha Hydroxy Acids: citric acid, glycolic acid, lactic acid, Beta Hydroxy Acid, Salicylic Acid, Humectants: glycerine, lecithin, Silicones: Dimethicone/Cyclomethicone, Sunscreen agents: titanium dioxide, Bleaching Agents: hydroquinone, Antioxidants: butylated hydroxy toluene (BHT), Preservatives: Parabens, benzoyl peroxide, Emollients: Cetyl alcohol, Steryl alcohol, Ceteareth 20, Cetearyl alcohol, Isopropyl Palmitate, Isopropyl Myristate, Castor Oil, Avocado Oil.
We also test Water, Caffeine and are in the process of obtaining laboratory instruments for Fire Point testing of cosmetic products. Learn more about the specific testing we offer by clicking on the Testing Services link.