Chloroform

Chloroform (trichloromethane) is a volatile chlorinated solvent historically used in chemical and pharmaceutical manufacturing and still monitored as a regulated impurity due to its toxicity and potential carcinogenicity. It has the molecular formula CHCl₃, a molecular weight of 119.38 g/mol, and is identified by CAS No. 67-66-3. Chloroform may be present as a residual solvent or process-related impurity in active pharmaceutical ingredients (APIs), excipients, and finished drug products.

Under ICH Q3C guidelines, chloroform is classified as a Class 2 solvent, requiring strict control at low concentration limits. Accurate determination of chloroform is routinely performed using gas chromatography (GC-FID or GC-MS), supported by reliable analytical standards to ensure sensitivity, precision, and regulatory compliance. High-quality chloroform standards are essential for method development, calibration, system suitability testing, method validation, and routine quality control. The use of well-characterized GC standards ensures reproducible results, data integrity, and compliance with global regulatory requirements, including USFDA and EMA expectations.

At Manasa Life Sciences, we provide high-purity chloroform analytical standards and technical expertise to support residual solvent analysis, method validation, and regulatory-aligned impurity control strategies. Our solutions help laboratories achieve accurate chloroform quantification and maintain compliance across the pharmaceutical product lifecycle.