CD Formulation announces that it is now able to provide a nitrosamine impurity analysis service for customers involved in drug formulation projects.
New York, United States – March 21, 2022 – Earlier this month, CD Formulation announced that it is now able to provide a nitrosamine impurity analysis service to customers who are involved in drug formulation projects and require assistance from CRO companies such as than CD Formulation.
Nitrosamine analysis can be difficult. These ultra-low levels of impurities must be quantified in a variety of complex matrices. Equipped with all necessary equipment, including LC/MS and GC/MS systems, CD Formulation is well positioned in the industry to perform nitrosamine impurity analysis.
The genotoxic and carcinogenic potential of N-nitrosamines raises a serious safety concern, and in September 2020, the FDA issued guidelines for the pharmaceutical industry regarding the control of nitrosamines in pharmaceutical products.
“The known causes of nitrosamine impurities in drugs can be manifold, including but not limited to the use of sodium nitrite (NaNO2) or other nitrifying agents, the use of contaminated raw materials in the manufacturing process of the active pharmaceutical ingredient (API), the use of recycled materials, the use of raw materials and intermediates contaminated with nitrosamines, or simply processes of degradation of raw materials, intermediates and drugs,” said a senior scientist at CD Formulation.
Nitrosamine impurity level analysis has become a mandatory step in APIs and drug formulation for some years to ensure drug quality and safety. Meanwhile, the USP General Chapter has also been developed to guide the proper control of nitrosamine impurities. To this end, various scientific and regulatory approaches should be adopted to eliminate or reduce the presence of nitrosamine in pharmaceutical products.
Although challenges such as low detection levels, difficult matrices and identification of unknown impurities may be encountered when attempting to analyze nitrosamine impurities, the CD Formulation laboratory is confident in achieving such a project. Its specialized team is highly 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 meet 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.
About CD wording
As 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 ready to offer ideas regarding the selection and tailoring of the most suitable excipients, in the hope of bringing out the best effects for APIs. A full range of drug testing services are readily available, including bacterial endotoxin testing, particle testing, extractables and leachables testing, pharmaceutical formulation, characterization testing, antimicrobial efficacy, disinfection efficacy testing, heavy metal testing, refractive index detection testing, nitrosamine impurity analysis and more.
Company Name: Formulation of CDs
Contact: Helen Smith
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The country: United States