USP 467-compliant analysis system for residual solvents: ChroZen USP 467
Young In's ChroZen USP 467 is an analytical system designed entirely to meet the requirements of USP 467 for the detection of residual solvents in pharmaceutical products. This method, imposed by the US Pharmacopoeia, regulates the presence of volatile organic compounds resulting from the manufacturing process of active substances or excipients, or from the final preparation of medicines. As these compounds are potentially toxic, their accurate measurement is essential to ensure patient safety.
This system is based on the combination of the ChroZen GC gas chromatograph with the Headspace ChroZen PAL 3 Series II. Together, they form a perfectly calibrated platform for identifying and quantifying Class I solvents (the most toxic, such as benzene and carbon tetrachloride), Class II solvents (moderately toxic, such as acetonitrile and toluene) and Class III solvents (low toxicity but requiring monitoring, such as ethanol and acetone). The tests are performed according to Protocol A of USP 467, ensuring strict compliance with separation, resolution and signal-to-noise ratio criteria.
The ChroZen USP 467 also stands out for its ease of use. It includes chromatographic control software with preconfigured method files, a dedicated user manual and a set of consumables specified for this application. The system uses an Rxi-624Sil MS intermediate polarity column (30 m × 0.32 mm × 1.80 µm), optimised for separating organic solvents with high precision.
The analytical performance of the system is proven by chromatogram results that comply with pharmacopoeia requirements. For example, all Class I solvents show a signal-to-noise ratio greater than 3, and even greater than 5 for 1,1,1-trichloroethane. The measured resolution between acetonitrile and dichloromethane reaches 2.48, well above the required threshold of 1.
By integrating validated hardware, software, accessories and analysis parameters, the ChroZen USP 467 enables laboratories to save time while ensuring regulatory compliance. It is designed for any organisation wishing to meet the quality requirements imposed by health authorities for finished pharmaceutical products, while ensuring rigorous traceability of results.
