Genotoxic Impurity / Nitrosamine Testing

Ensuring the safety and efficacy of pharmaceutical products requires thorough testing for genotoxic impurities. At Apta Labs Pvt Ltd, we specialize in advanced genotoxic impurity testing, including detailed nitrosamine analysis, to ensure your products meet the highest safety standards and regulatory requirements.

Genotoxic Impurity Testing

Genotoxic impurities are substances that can cause genetic mutations or cancer. Accurate detection and quantification of these impurities are critical to safeguarding patient health and ensuring product compliance.

Comprehensive Screening:
Identifying and quantifying genotoxic impurities in drug substances and finished products using advanced analytical methods.
Regulatory Compliance:
Adhering to international guidelines and standards such as ICH M7 and USP, ensuring that your products meet all necessary safety and quality benchmarks.

Nitrosamine Testing

Nitrosamines are known carcinogens that can pose significant health risks if present in pharmaceutical products. Our specialized nitrosamine testing services are designed to detect and quantify these harmful compounds with precision.

Advanced Detection Methods:
Utilizing state-of-the-art techniques such as gas chromatography coupled with mass spectrometry (GC-MS) and high-performance liquid chromatography with mass spectrometry (LC-MS) for sensitive and accurate nitrosamine analysis.
Regulatory Adherence:
Following stringent regulatory guidelines including those from the USFDA, EMA, and recent updates in industry standards for nitrosamine testing.
Custom Method Development:
Developing and validating tailored methods for nitrosamine detection specific to your product requirements.

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Apta Labs Pvt Ltd is a premier contract research and testing laboratory providing a comprehensive range of services to the pharmaceutical, biopharmaceutical, and packaging industries.