Earlier this month, CD Formulation announces that it is now capable of providing nitrosamine impurities analysis service for customers who are involved with drug formulation projects and need help from CRO companies like CD Formulation.
The analysis of nitrosamines can be challenging. These ultra-low levels of impurities must be quantified in a variety of complex matrices. Equipped with all the equipment needed, including LC/MS and GC/MS systems, CD Formulation is well-positioned in the industry to carry out nitrosamine impurities analysis.
The genotoxic and carcinogenic potential of N-nitrosamines raises a serious safety concern, and in September 2020, the FDA issued guidance for the pharmaceutical industry regarding the control of nitrosamines in drug products.
“The known causes for Nitrosamine Impurities in drugs can be multi-faced, including but not limited to the use of sodium nitrite (NaNO2) or other nitrifying agents, the use of contaminated raw materials in the active pharmaceutical ingredient (API) manufacturing process, the use recycled materials, the use of raw materials and intermediates contaminated with nitrosamines, or simply degradation processes of starting materials, intermediates and drugs,” a senior scientist from CD Formulation indicated.
The analysis of nitrosamine impurities levels has become a mandatory step in APIs and drug formulation since a few years ago to ensure drug quality and safety. Meanwhile, USP General Chapter < 1469 > has also been developed to guide the appropriate control of nitrosamine impurities. To this end, varieties of scientific and regulatory approaches should be adopted to eliminate or reduce nitrosamine’s presence in pharmaceuticals.
Although challenges like low detection levels, difficult matrices and unknown impurity identification can be encountered in the nitrosamine impurities analysis attempt, CD Formulation’s laboratory is confident in accomplishing such a project. Its specialized team is very experienced in the development and validation of highly sensitive and specific methods to assess carcinogenic impurities in pharmaceutical products.
In addition to experienced drug impurity analysis, we can also address the needs of extract and leachate detection, elemental impurity analysis, etc. Please visit https://www.formulationbio.com/analysis-of-nitrosamine-impurities.html to learn more.
Being a science-driven company, CD Formulation is a trusted brand, serving as a CRO company in the pharmaceutical industry to develop, design and produce pharmaceutical excipients. The scientific team is always prepared to offer insights regarding the selection and custom manufacturing of the most appropriate excipients, hoping to bring out the best effects for APIs. A full range of drug analytical services are easily accessible, including bacterial endotoxin testing, particulate matter test, extractables & leachables test, pharmaceutical formulation, characterization testing, antimicrobial effectiveness testing, disinfection efficacy testing, heavy metal testing, refractive index detection test, analysis of nitrosamine impurities and more.