The Challenge:
Regulatory agencies now require extremely sensitive detection of nitrosamines and Nitrosamine Drug Substance Related Impurities (NDSRIs). Non-compliance can lead to product recalls, market withdrawals, and severe reputational damage.
Our Approach:
CLS performs comprehensive evaluation, identification, and quantification of nitrosamines and NDSRIs. Our team handles complete study design, method development, and validation to meet allowable maximum daily exposure targets.
Our Expertise
We have extensive expertise in nitrosamine impurity testing for a broad range of pharmaceutical dosage forms, including API’s. tablets, capsules, oral solutions, injectables, and other finished pharmaceutical products.Handled about 200 projects for the determination of nitrosamines covering both General nitrosamines and NDSRI’s.
Our capabilities include the sensitive detection, identification, and quantitative determination of nitrosamine impurities, supporting pharmaceutical manufacturers in evaluating and controlling nitrosamine risks in accordance with applicable ICH, FDA, EMA, and other global regulatory expectations.
Our analytical approach is designed to provide high sensitivity, accuracy, specificity, and reliable quantification, enabling robust assessment of nitrosamine impurities throughout pharmaceutical product development and quality control.
Why It Matters
Track Record
Applications
- Drug Products
- Oral Product (Tablets, Capsules, Ointment)
- Parental Product
- Ophthalmic Product
Regulatory Standards
Instrumentation
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.