Testing and analysis strategies for drug impurities and residual solvents are key to optimizing the purity, safety, and quality control of active pharmaceutical ingredients (APIs) and finished products. CD Formulation is committed to providing customers around the world with a wide range of impurity and residual solvent analysis services to ensure product safety and quality and accelerate time to market.
Pharmaceutical impurity and residual solvent analysis are essential for ensuring the safety, efficacy, and quality of pharmaceutical products, as well as for maintaining regulatory compliance. Impurities in pharmaceuticals come from many sources, including:
These impurities can be organic or inorganic, and are present at very low or trace levels, often negatively affecting product quality and performance. Therefore, strict quality control and analysis of raw materials and intermediate products as well as finished products are required during the production process to ensure that the products are not affected by these impurities and comply with regulatory requirements.
As experts in the development of innovative drug delivery systems and a global leader in CMC analysis, CD Formulation provides unparalleled impurity and residual solvent analysis services to our global clients in drug development, ensuring their drugs meet all quality standards before approval by stringent regulatory agencies.
We have the most advanced equipment and technology to accurately and quickly analyze any impurities or residual solvents that may be present in drugs to ensure the safety, purity, and effectiveness of the drugs.
Our impurity analysis expert team provides standard elemental impurity analysis testing based on the methods described in the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP) general chapters and can conduct 24 potential elementals analysis that is included in the ICH Q3D guidelines for APIs, excipients, and formulations.
In addition, our team of impurity analysis experts provides nitrosamine impurity analysis services based on the testing methods for N-nitrosodimethylamine (NDMA) impurities in some drugs issued by the FDA, and conducts analysis and testing for 7 kinds of nitrosamine impurities that may exist in raw materials and drugs:
Available impurity analysis projects:
| projects | Source of impurities | Available analytical methods | Available analysis projects |
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| Elemental impurity |
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| Nitrosamine impurity analysis |
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Residual solvents in pharmaceuticals refer to volatile organic solvents used in the manufacturing process of raw materials or pharmaceuticals. Our team of pharmaceutical impurity analysis experts provides unparalleled residual solvent measurement and identification services, helping customers around the world ensure that residual solvents in drug products, drug substances, and excipients have been reduced to acceptable levels.
Our expert team of drug impurity analysis performs standard residual solvent analysis tests according to the methods described in the USP<467> and the EP to ensure that residual solvents in all excipients and drug substances as well as finished products are controlled.
In addition to the above impurity analysis and residual solvent analysis services, for biological products, CD Formulation also supports process-related impurities, genotoxic impurities, and other testing services. Please contact our scientists to learn more about impurity analysis services for biological products and other related testing services.
CD Formulation has extensive experience and expertise in performing impurities and residual solvent analysis services. Our team of experienced scientists will work with you to develop a customized testing plan that meets your specific needs. Please contact us to learn more about how we can help you conduct impurities and residual solvent testing and verify the safety of your products to regulatory requirements.
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