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At Neopharm, we offer a range of nitrosamine testing services to support risk assessment and ensure compliance with regulatory guidelines. Our comprehensive screening methods can detect and quantify general nitrosamine impurities, including those listed by Health Canada, FDA, and other regulatory authorities. We also provide method validation and confirmatory testing on drug substances and drug products, following USP <1469>, Health Canada, FDA, and EMA guidelines. Additionally, our team is experienced in developing and validating custom methods for Nitrosamine Drug Substances-Related Impurities (NDSRIs or complex nitrosamines), such as nitroso adducts of drug substances or excipients. Trust us for accurate and reliable nitrosamine analysis tailored to your specific requirements.
Neopharm offers in-house method on LC/MS triple quadrupole based on FDA-proposed methods to determine nitrosamines. Sample preparation and instrumental parameters are adjusted for each product of interest depending on the dosage form and release pattern to ensure the detection of ultra-trace levels (as low as ppb level of the nitrosamines of interest).
Health Canada, FDA, EMA, and other regulatory authorities have established guidelines for the detection and control of nitrosamine impurities in pharmaceuticals. Our testing methods align with these guidelines, allowing us to accurately detect and quantify nitrosamines listed by regulatory authorities. By complying with these guidelines, our clients can meet regulatory requirements and ensure the safety and quality of their products.
If required, the previously developed methods can be optimized and fully validated as per ICH Q2(R1) requirements to allow subsequent GMP testing of the drug substance or drug product.
Using validated methods, nitrosamines analysis can be performed on demand for specific developed or commercialized batches of drug substances or drug products. This test can also be added to the stability program to monitor the trend of formation of nitrosamines of specific interest over the drug product shelf life or using accelerated conditions.
Some nitrosamines, such as Nitrosamine Drug Substances-Related Impurities (NDSRIs), may require customized testing methods due to their complex nature. Our experienced team can develop and validate custom methods specifically designed to analyze these complex nitrosamines. With our expertise, we can provide tailored solutions to address the unique challenges associated with testing nitroso adducts of drug substances or excipients.
When levels of Nitrosamines become an issue for a specific drug product, Neopharm can support development of mitigation strategies by performing stress studies with various levels of antioxidants, such as commonly used ascorbic acid and a-tocopherol. These studies can be performed in solution for initial design of potential formulation and then followed in stability chambers for precise trending of the impact on nitrosamine concentration.
We offer a comprehensive solution for all your nitrosamine testing this nitroso adducts of drug substances or excipients.
Our general analytical method can detect the main nitrosamines listed by Health Canada, FDA, and several other regulatory authorities. These include commonly found nitrosamines such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosodiisopropylamine (NDIPA), and many others. We can also accommodate any additional nitrosamines upon the client's request.
Yes, we provide method validation services for nitrosamine testing. Our validation protocols follow ICH Q2(R1) guideline among with USP <1469>, Health Canada, FDA, and EMA requirements, ensuring that the methods are robust, accurate, and reliable. Method validation is essential for establishing the suitability and performance of the testing method for specific drug substances or drug products.
Absolutely. Our team has expertise in developing and validating custom methods for the analysis of Nitrosamine Drug Substance-Related Impurities (NDSRIs or complex nitrosamines), including nitroso adducts of drug substances or excipients. We understand the challenges associated with these compounds and can design specialized testing approaches to ensure accurate detection and quantification.
Nitrosamines are known to be potentially carcinogenic, and their presence in pharmaceutical products is therefore considered unacceptable by health authorities as it can pose risks to patient's health. By performing nitrosamine testing, we can identify the presence of these impurities and assess the potential risks associated with the products. Enabling our clients to take proactive measures to mitigate risks, ensure product safety, and maintain regulatory compliance.
For comprehensive nitrosamine testing services tailored to your specific needs, trust Neopharm. Our experienced team, advanced analytical methods, and compliance with regulatory guidelines ensure accurate and reliable analysis of nitrosamine impurities. Contact us today to discuss your requirements and preserve the safety and quality of your pharmaceutical products.Contact us