Residual Solvents Testing –
Ensuring Purity, Safety & Compliance
Residual solvents are organic volatile chemicals used or produced during the manufacturing of Active Pharmaceutical Ingredients (APIs), excipients, or finished products. While they are necessary for synthesis and formulation, excessive levels can pose toxicological risks and affect product quality. Regulatory authorities such as ICH, USP, EP, BP, and IP have set strict limits for residual solvents in pharmaceuticals (ICH Q3C guidelines). At SIMA LABS, we perform precise quantitative analysis of Class 1, Class 2, and Class 3 solvents using advanced techniques like Gas Chromatography (GC) with Headspace Sampling, ensuring your products meet safety, efficacy, and regulatory standards.
Why Choose SIMA LABS for Residual Solvents Testing?
- ICH Q3C Compliance – Testing aligned with global pharmacopeial guidelines.
- Comprehensive Coverage – Class 1 (toxic), Class 2 (limited), and Class 3 (low risk) solvents.
- Advanced Technology – Headspace GC-FID & GC-MS for ultra-trace detection.
- Wide Product Scope – APIs, excipients, and finished dosage forms.
- Validated Methods – Ensuring accuracy, precision, and reproducibility.
- Regulatory-Ready Reporting – Accepted by domestic & international authorities.
35+ Years of SIMA LABS – Residual Solvents Testing You Can Trust
SIMA LABS is NABL accredited and approved under FSSR and BIS for the detection and quantification of residual solvents in compliance with ICH Q3C, USP <467>, EP, BP, and IP guidelines. Our testing ensures that all pharmaceutical materials meet global safety limits for organic volatile impurities, supporting both domestic and export market requirements.
We provide precise and validated residual solvent analysis for pharmaceuticals to ensure safety, efficacy, and compliance.
Scope of Testing:
Materials Covered:
Active Pharmaceutical Ingredients (APIs)
Excipients
Finished dosage forms
Solvent Classes Tested:
Class 1: Known human carcinogens (e.g., benzene, carbon tetrachloride)
Class 2: Solvents with potential toxicity (e.g., methanol, acetonitrile, toluene)
Class 3: Low toxic potential solvents (e.g., ethanol, acetone)
Technology Used:
Gas Chromatography (GC) with Headspace Sampler
GC-FID and GC-MS for ultra-trace detection
Regulatory Compliance:
ICH Q3C (R6) guidelines
USP <467>, EP, BP, IP standards
Additional Capabilities:
Method development and validation for complex matrices
Routine batch release testing and R&D support
With cutting-edge instrumentation, stringent quality control, and expert chemists, SIMA LABS ensures your products meet the highest safety and purity standards for residual solvents.
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our customers are the driving force behind our growth and innovation
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Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
Residue Analysis
SIMA LABS offers residue testing and compliance with ELV, RoHS, REACH, and EN71 standards
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Molecular Biological Analysis
SIMA LABS offers GMO, allergen, pathogen testing, event identification, and pharma analysis for safety and compliance.
Method Development and Validation Studies
SIMA LABS provides stability testing, drug analysis, quality checks, lab consultancy, training, and R&D support.
Environment Monitoring
SIMA LABS offers environmental testing for pollutants, gases, and air quality monitoring.
Get In Touch
At SIMA LABS, we’re proud to offer our expertise in analysis and research to help you find the right solutions.
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