Pharmaceutical Impurity Testing

Mérieux NutriSciences | Pharma & Healthcare GxP facilities can develop and validate suitable and highly sensitive methods to detect, identify and quantify organic and inorganic impurities at trace levels. Impurities are identified and quantified by means of state-of-the-art analytical equipment.

Pharma Service Catalogue

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Complete List of Technologies

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Pharmaceutical Impurity Testing: Our Labs

State-of-the-art facilities: Our laboratories are equipped with cutting-edge technology and advanced instruments to detect and analyze impurities with high precision.
Regulatory compliance: We strictly adhere to cGMP (current Good Manufacturing Practice) regulations to ensure the quality and reliability of our test results.
Comprehensive testing services: We offer a wide range of testing services to identify and quantify impurities in various pharmaceutical products, ensuring they meet regulatory standards.

Our Capabilities

Advanced analytical techniques: Our lab utilizes sophisticated analytical methods for accurate impurity profiling.
Low-level detection: We specialize in detecting and quantifying trace impurities at very low levels, even in complex sample matrices.

Our Teams

R&D expertise: Our dedicated R&D team focuses on method development to create robust and reliable testing protocols.
GMP compliance: We have a GMP lab dedicated to method validation and quality control (QC) to maintain the highest standards.
Experienced scientists: Our team consists of experts in pharmaceutical analysis with decades of experience in identifying and quantifying impurities in active pharmaceutical ingredients and drug products.

Our Services Dedicated to Pharmaceutical Impurities

Organic Impurities

Control of starting materials, by-products, and intermediates (including chiral impurities) in compliance with pharmacopoeia requirements or Sponsor specifications.
Characterization of degradation products through forced degradation studies (stress test) under acidic, basic, oxidative, and various heat and light-exposure conditions.

Inorganic Elemental Impurities

Elemental impurities are a potential hazard in drug products: it is necessary to monitor their presence and their levels must remain within acceptable concentrations. Competent Authorities set binding limits for metal residues in pharmaceutical products and have also proposed official methods for their control.

Identification of Unknown Impurities

The identification of pharmaceutical impurities is a critical analytical activity in the drug development process. The aim is to fully elucidate the chemical structures of unknown pharmaceutical impurities present above a certain concentration in medicinal products. Knowledge of the chemical structure of an impurity is essential in order to assess the toxicological implications and to gain an understanding of how the impurity formed. Furthermore, knowledge of the formation mechanism is critical for improving the synthetic chemical processes and optimizing the drug’s formulation to reduce or eliminate the impurity.

Mérieux NutriSciences | Pharma & Healthcare proposes strategies for the identification of pharmaceutical impurities using various approaches and instruments, including: