Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Nitrosamine impurities, such as NDMA and NDEA, are potent carcinogens formed during pharmaceutical manufacturing or storage. These arise from nitrosating agents reacting with secondary or tertiary amines under acidic conditions.
Regulatory authorities worldwide mandate stringent risk assessments for identification, evaluation, and control. GLOBAXA provides comprehensive strategies to detect, quantify, and mitigate nitrosamine impurities, ensuring compliance with ICH M7, FDA, EMA, WHO, and other global guidelines.
Impurities Involved
- N-Nitrosodiisopropylamine (NDIPA)
- N-Nitrosodibutylamine (NDBA)
- N-Nitrosomorpholine (NMOR)
- N-Nitrosopyrrolidine (NPYR)
- N-Nitrosopiperidine (NPIP)
- N-Nitrosodiphenylamine (NDPhA)
- Other Secondary Amines like methylamine and diethylamine
Detection & Quantification Techniques
- GC-MS, HPLC, LC-MS/MS, HS-GC for ultra-trace detection
- Derivatization methods to enhance sensitivity
QSAR Modelling & Expert Review
- Predict mutagenic/carcinogenic potential
- Support Acceptable Intake (AI) limits
- Prioritize impurities and validate with expert review
GLOBAXA Services
- Risk assessments across API synthesis and raw materials
- Regulatory compliance with USFDA, EMA, MHRA, and others
- Remediation and risk mitigation strategies
- Analytical monitoring and method validation
Expertise
- In silico models: DEREK Nexus, OECD QSAR Toolbox, CASE Ultra
- Predict carcinogenic risk, perform read-across and CPCA
- Mechanistic understanding of formation and metabolism
- Translate QSAR outputs into actionable regulatory insights
- Prepare QSAR-based regulatory documentation