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Analytical Development
Analytical Development
Mavens’ analytical team is skilled in a variety of chromatographic and spectroscopic techniques. Method creation for raw materials, in-process monitoring, intermediates, and finished products, as well as support for regulatory filings, increase the analytical capabilities. The team is also skilled in establishing stability indicating methods, doing method validation in accordance with ICH Q2, performing release analysis, and transferring methods to the execution site.
The team also has experience with genotoxic impurities in Active Pharmaceutical Ingredients (APIs) as per ICH M7, structural elucidation, characterization of standards, evaluation of residual solvents and elemental impurities as per ICH Q3, and evaluation of residual solvents and elemental impurities as per ICH Q3.
We also conduct stability tests in accordance with ICH Q1 under a variety of temperature and humidity settings in order to determine the container closure system, storage condition, and shelf life of the product.
ANALYTICAL ACTIVITIES
Validation, Verification, and Transfer of Analytical Methods: Validation of analytical methods in accordance with ICH guidelines. Assistance with technique validation and transfer to the execution location, as well as guaranteeing reproducibility of results.
Mavens offer extended stability tests under a variety of temperature and humidity settings in order to determine appropriate storage conditions, container closure, and API shelf life in order to meet regulatory requirements.
We have considerable expertise doing forced degradation experiments for pharmacological compounds under acidic, basic, oxidative, photolytic, and thermal settings, as well as identifying and characterizing probable degradation products and their production mechanisms.
Impurity Identification, Isolation, and Characterization:
- Using diverse techniques such as flash chromatography, liquid-liquid extraction, and preliminary HPLC, develop strategies to isolate contaminants in the regulatory starting material, advanced intermediates, and APIs.
- LCMS/MS and NMR spectroscopy were used to investigate the structure of the separated impurities.
- Report writing in preparation for regulatory submission.
Reference and working standards qualification:
- Preparation of working standards for raw materials, intermediates, impurities, and finished products by selecting high-purity material and comparing it to approved reference/working standards.
- In the absence of an official reference/working standard, purification, characterisation, and mass balance of a specific material are used to prepare and qualify reference standards.
Metal/Elemental Analysis:
- Direct aspiration of sample solution in organic solvents
- Microwave digestion system that can digest a wide range of samples and sizes
- To satisfy ICH Q3D restrictions, a laboratory with competence in producing reliable and exact trace and ultra-trace level studies is required.
- Identifying and quantifying elemental/metal composition in a variety of sample types
- Reference standards that are traceable to international standards are used.