Zhejiang Huayi Pharmaceutical Co. Ltd.

A review.The background of regulatory guidance, the valuation and the control strategy of genotoxic impurities in active pharmaceutical ingredients (API) were introduced.Based on the understanding of regulatory expectations on the control of genotoxic impurity by studying of the history of European and US regulations, methods were proposed for assessing and controlling genotoxic impurities in drug substances.The most effective way to achieve the regulatory expectations is to establish control strategies based on a combination of semi-quant. assessment, allied to anal. results and data from appropriate purging studies.Such an approach should ensure that any actual genotoxic impurity related risk is clearly identified and managed.

In this paper, related substances in enrofloxacin, including ciprofloxacin, 6-ethylpiperazinyl-7-chloro-enrofloxacin and defluorinated enrofloxacin, were detected by HPLC.The results showed that there was no 6-ethylpiperazinyl-7-chloro-enrofloxacin detected, and the quality of enrofloxacin could be controlled by the method in Europe Pharmacopeia.

The objective of the paper is to establish a HPLC method for the determination of related substances in clarithromycin.C₁₈ column with 4.76 g/L potassium dihydrogen phosphate solution (adjusted to pH 4.4 with dilute phosphoric acid) acetonitrile as the mobile phase.The detection wavelength was 205 nm.The results showed that the related substances and their main degradation products were determined by HPLC.The quantitation limit was 0.01 μg/mL.It was concluded that the HPLC method proposed for determination of the related substances in clarithromycin is sensitive, accurate and simple.