Avoid United States FDA Recalls with Routine Nitrosamine Impurity Testing for API and Drug Product скачать в хорошем качестве

Avoid United States FDA Recalls with Routine Nitrosamine Impurity Testing for API and Drug Product

Avoid United States FDA Recalls with Routine Nitrosamine Impurity Testing for Your API and Drug Product ResolveMass Laboratories Drug recalls in the United States have surged due to nitrosamine impurities such as NDMA, NDEA, and NMBA—probable human carcinogens linked to cancer risk. Since the 2018 valsartan recall, the FDA, EMA, and Health Canada have tightened requirements for nitrosamine impurity testing in pharmaceuticals. In this video, we explain how routine nitrosamine impurity testing can help pharmaceutical manufacturers: ✔ Prevent FDA recalls and enforcement actions ✔ Comply with ICH M7(R1) and USP [1469] guidelines ✔ Detect nitrosamines in APIs, finished drug products, excipients, and packaging ✔ Protect patient safety and brand reputation At ResolveMass Laboratories Inc., we specialize in FDA-compliant nitrosamine impurity testing in the United States, using advanced LC-MS/MS, GC-MS, and HRAM-Orbitrap technologies for ultra-trace detection. 🔗 Start your nitrosamine testing project today: https://resolvemass.ca/nitrosamine-im... #NitrosamineTesting #FDACompliance #ResolveMassLaboratories #PharmaTesting #DrugSafety #NDMA #NDEA #PharmaRegulations #USFDA #ICHM7 #USP1469 #PharmaceuticalTesting #FDARecalls #APIManufacturing #DrugProductTesting