In the pharmaceutical industry, residual solvents are defined as volatile organic compounds that are used or produced during the manufacturing of drug substances or excipients. These residual solvents may be present in the final drug product that could be harmful to human health, with potential risks ranging from toxicity to carcinogenicity. Regulatory agencies, such as the US Food and Drug Administration (FDA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), have established guidelines for the acceptable levels of residual solvents in drug products. Therefore, performing residual solvents analysis is necessary to comply with these regulatory requirements and ensure the safety of drug products for patients. Our company has established a specialized residual solvents analysis platform. Our team of experts utilizes state-of-the-art technology and methodologies to ensure accurate detection, analysis and quantification of residual solvents in pharmaceutical products, helping our clients meet regulatory requirements and ensure the safety and quality of their drug products.
Our Residual Solvents Analysis Platform
Our residual solvent analysis platform has the ability to provide method development and validation, as well as testing services for a wide range of solvents. According to ICH Q3C(R8), these solvents can be divided into the following categories:
1Class 1 solvents
Solvents that are known human carcinogens, mutagens, reproductive toxicants, or have a low therapeutic index. Examples include benzene, carbon tetrachloride, and chloroform.
2Class 2 solvents
Solvents that are not class 1 solvents but should be limited due to their inherent toxicity. Examples include acetonitrile, methylene chloride, and toluene.
3Class 3 solvents
Solvents with low toxic potential to humans. Examples include acetone, ethanol, and isopropanol.
All types of residual solvents listed in the ICH Q3C (R8) guidelines can be analyzed in our platform with precise and reliable results, safeguarding the integrity and safety of your products.
Instruments and Equipment
Residual solvents analysis requires specialized instrumentation and equipment. For this, our platform is equipped with a range of instruments and equipment, including but not limited to:
- Gas Chromatography (GC)
- Liquid Chromatography (LC)
- Nuclear Magnetic Resonance (NMR) Spectroscopy
- Near-Infrared Spectroscopy (NIR)
- Headspace Gas Chromatography (HS-GC)
- Fourier-Transform Infrared Spectroscopy (FTIR)
- Mass Spectrometry (MS)
- …
It is noted that GC is the primary analytical technique used for residual solvents analysis due to its high sensitivity and selectivity. Therefore, our platform has equipped it with a variety of detectors including FID, TCD, ECD, NPD, MS, MS/MS, ensuring that all kinds of solvents are analyzed.
Applicable Methods
Our platform enables analysis of residual solvents according to USP<467>or any method provided by the customer.
Note: The USP<467>is most used method in the pharmaceutical industry to ensure compliance with regulatory requirements. This method outlines the procedures and acceptance criteria for the identification and quantification of residual solvents in pharmaceutical products.
Process at Our Platform
- Sample Preparation: The first step in our process is sample preparation, where the drug product is carefully extracted to isolate the residual solvents.
- Instrumentation: We utilize advanced and suitable instrumentation, such as GC-MS and HS-GC, to analyze residual solvents in pharmaceutical products based on appropriate analytical methods.
- Data Analysis: Once the analysis is complete, we carefully analyze the data to determine the presence and levels of residual solvents in the drug product.
- Reporting: Finally, we provide detailed reports to our clients, outlining the results of the residual solvents analysis. These reports include information on the solvents detected, their levels, and any relevant regulatory requirements that have been met. For method development and validation, this report will detail the methodology, results, and conclusions of the analysis, as well as provide any necessary documentation and data to support the findings.
With state-of-the-art equipment and experienced analytical chemists, we offer comprehensive analysis for a wide range of residual solvents in various matrices. Trust our platform to deliver accurate results and help you meet regulatory requirements with confidence. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
