Protheragen-ING Lab provides measurement and identification services for residual solvents in pharmaceuticals. Residual solvents, also known as organic volatile impurities (OVI), refer to impurities that are not removed during product purification. These impurities can be active pharmaceutical ingredients (APIs) or residues from the manufacturing process of the drug substance and excipients. Residual solvents may also form during packaging or storage. Residual solvents can also form during packaging or storage processes. It is crucial to ensure that the levels of residual solvents in pharmaceutical products do not exceed the safety limits supported by the available data.
Our expertise
With our comprehensive expertise in residual solvent analysis, we assist our clients in ensuring that residual solvents are reduced to acceptable levels, thereby ensuring compliance with the limits specified in ICH Q3C(R5) or USP <1467>, as well as unique limits set by pharmaceutical manufacturers for specific solvents.
Our team of experts has accumulated extensive experience in residual solvent research, successfully handling numerous cases. We offer efficient solutions for various types of residual solvents and can provide a comprehensive strategy for residual solvent research in pharmaceuticals. Our research results meet the requirements of domestic and international drug registration studies, support client audits, and can be tailored to facilitate on-site inspections by regulatory authorities worldwide.
Our comprehensive testing services
We provide a comprehensive range of services tailored to the regulatory requirements and specific needs of residual solvent testing:
Development, Validation, and Testing According to ICH Q3C(R5) or USP <1467>:
- Development and validation (confirmation) of analytical methods in compliance with the guidelines.
- Testing of pharmaceutical samples using validated methods.
Qualitative Analysis of Unknown Solvents Using Mass Spectrometry:
Utilization of gas chromatography-mass spectrometry (GC-MS) or gas chromatography-tandem mass spectrometry (GC-MS/MS) to perform qualitative analysis of potential unknown solvents in samples.
Flexible Approaches for Nitrogenous Basic Compounds:
In cases where gas chromatography may not be suitable for determining nitrogenous basic compounds, our laboratory has extensive experience in using alternative analytical techniques such as ion chromatography to ensure accurate measurement.
Residual solvent guidelines and regulations
Protheragen-ING performs residual solvent testing according to the following regulations:
- ICH Q3C Impurities: Guideline for Residual solvents.
- USP <1467> Residual solvents - Verification of Compendial Procedures and Validation of Alternative Procedures.
For reliable and comprehensive drug residual solvent testing services, trust Protheragen-ING Lab, where our experienced team of experts is dedicated to ensuring the safety and compliance of your medicines. Contact us today to discuss your specific requirements and benefit from our expertise in residual solvent analysis.