Acetonitrile

Acetonitrile is a widely used polar aprotic solvent in pharmaceutical, chemical, and analytical laboratories, particularly in chromatographic applications. It has the molecular formula C₂H₃N, a molecular weight of 41.05 g/mol, and is identified by CAS No. 75-05-8. Due to its extensive use in synthesis and purification processes, acetonitrile may be present as a residual solvent in active pharmaceutical ingredients (APIs) and finished drug products.

Under ICH Q3C guidelines, acetonitrile is classified as a Class 2 solvent, requiring controlled limits and routine monitoring to ensure patient safety. Accurate determination of acetonitrile at trace levels is typically performed using gas chromatography (GC-FID or GC-MS), supported by high-quality analytical standards for reliable calibration and quantification. The use of well-characterized acetonitrile standards is essential for method development, validation, system suitability, and ongoing quality control, ensuring reproducible results and compliance with global regulatory expectations, including USFDA and EMA requirements.

At Manasa Life Sciences, we support pharmaceutical and analytical laboratories with high-purity acetonitrile analytical standards and technical expertise in residual solvent analysis, method development, and regulatory compliance, helping ensure robust impurity control and data integrity across the product lifecycle.