Nitrosamine Analysis (NDMA & NDEA) in Raw Materials/Excipients and Finished Product by UPLC-QDa

Although ultimately comprising up to 90% of a final drug product, raw materials and excipients traditionally have not received the same level of attention from regulators as APIs. However, this has changed recently due to the nitrosamine impurity crisis, with regulatory authorities urging a focus on the entire sourcing and drug manufacturing process. Manufacturers must understand the source and quality of all materials incorporated into their products to avoid recalls and lost profits, while raw material suppliers must assure purchasers of the quality of their products.
What must raw materials and excipients users, as well as suppliers, know about impurities to avoid warning letters and regulatory action? What technologies or techniques can be used to demonstrate added confidence in the quality of raw materials?

In this eChalk Talk, Donovan Werke, a Guatemalan generic drug manufacturer, will discuss manufacturing processes to reduce impurity presence as far as possible, as well as laboratory analysis of incoming raw materials and finished product to determine nitrosamine concentration using UPLC with mass detection, with candesartan and metformin as examples.

Presenter: Gabriela Grijalva, M.S. (Donovan Werke)

Gabriela Grijalva is a Physicochemical Analyst at Donovan Werke in Guatemala City, Guatemala. She is responsible for analyzing physical and chemical properties of raw materials, bulk, and finished products using liquid chromatography, high efficiency liquid chromatography, and spectrophotometry, to ensure the quality of the products. She is also responsible for analyzing and approving daily drinking, purified and injection water for use in production. Gabriela holds a Master’s Degree in Industrial Engineering from the University of San Carlos of Guatemala.