Erythromycin ethylsuccinate-made components and analysis of related substances.docVIP

 PAGE \* MERGEFORMAT 14 Erythromycin ethylsuccinate-made components and analysis of related substances Author: Yang Yali Wang Chen Wang Mingjuan HU Chang-Qin [Abstract] Objective To investigate the domestic raw materials and formulations of erythromycin ethylsuccinate components and related substances, for the revision of the Chinese Pharmacopoeia 2005 edition of erythromycin ethylsuccinate provide the basis for quality standards. Methods The United States Pharmacopoeia 30 edition of income contained in the HPLC determination of six factories erythromycin raw materials, raw materials and formulations of erythromycin ethylsuccinate a total of 16 batches of samples of components and related substances, and the adoption of the European Pharmacopoeia 5.0 version of the method reproduces Determination of erythromycin ethylsuccinate erythromycin content of free samples. The results of Erythromycin Erythromycin A main component, containing a small amount of erythromycin B, erythromycin C, erythromycin E components, primarily for dehydration related substances in erythromycin A, compared with other related substances less. Erythromycin for the synthesis of erythromycin ethylsuccinate in the main related substances in erythromycin for free. Findings suggested that the Chinese Pharmacopoeia 2005 edition of erythromycin ethylsuccinate related substances in thin-layer chromatography to amend the high-performance liquid chromatography, to facilitate better control of product quality. [Keywords:] erythromycin ethylsuccinate; HPLC; components and related substances; free erythromycin ABSTRACT Objective To investigate the related substances profiles of the domestic erythromycin ethylsuccinate bulk material and preparation, and provide data for the monograph of erythromycin ethylsuccinate in the Chinese Pharmacopoeia 2005. Method The ingredient and the related substances of totally 16 batches of erythromycin ethylsuccinate bulk material and preparation of 6 manufacturers we