WHAT IS RESIDUAL SOLVENT TESTING

Residual solvent testing determines the presence and concentration of volatile organic chemicals that remain after manufacturing processes such as extraction, purification, or formulation. These solvents can affect product safety, stability, and performance if not removed properly.

WHY RESIDUAL SOLVENT TESTING IS IMPORTANT FOR PRODUCT QUALITY

Testing for residual solvents ensures your products remain safe, stable, and compliant with international standards

Key reasons to perform residual solvent testing include:

• Protecting Consumer Safety: Detect and control toxic or harmful solvent residues to prevent health risks and ensure the safety of end users.
• Ensuring Regulatory Compliance: Meet the strict testing and reporting standards set by the Ministry of Health (MOH), ICH Q3C, and global pharmacopeias.
• Preserving Product Integrity and Quality: Prevent solvent-related degradation, maintain batch consistency, and uphold your brand’s safety and performance standards.

WHAT WE TEST IN RESIDUAL SOLVENT ANALYSIS

BIOCHEM’s testing covers a wide range of solvents categorized under ICH Q3C guidelines:

• Class 1 Solvents (Toxic): Benzene, carbon tetrachloride, 1,2-dichloroethane, 1,1-dichloroethene, and 1,1,1-trichloroethane.
• Class 2 Solvents (Limited Use): Methanol, acetonitrile, toluene, chloroform, and N, N-dimethylformamide (DMF).
• Class 3 Solvents (Low Toxic Potential): Ethanol, acetone, ethyl acetate, and isopropanol.

HOW BIOCHEM RESIDUAL SOLVENT TESTING SUPPORTS COMPLIANCE

At BIOCHEM, our GC-FID and GC-MS analytical systems deliver precise quantification of solvent residues to help you meet local and international regulatory standards.

Testing is performed using validated methods such as ASTM F1884-04 (for packaging or material applications) and gas-chromatographic methods in line with global guidelines, including ICH Q3C and USP <467>. This ensures reliable results for pharmaceutical, cosmetic, and packaging applications.

Each report includes full analytical data, solvent classification, and limit evaluations to support your product registration, audit readiness, and continuous quality assurance.