Authors: Maria Neagu, Cristina I. Marinescu, Roxana M. Covaci, Catalina S. Macovei Affiliation: SC Delos Impex ’96 SRL, Bucharest, RO.
Because, triclabendazole is an active pharmaceutical ingredient without compendial monography (European Pharmacopoeia, United Stated Pharmacopoeia) in SC Delos Impex ’96 SRL, the API identification, assay, related substances, and, preservatives, assay and identification is efectuated used the method presented below. Presented original method permit, all these determination in a relative short time (the chromatogram time recorded is 25 min.).
Authors: Maria Neagu, Cristina Marinescu, Carmen Popescu Affiliation: SC DELOS IMPEX ’96 SRL, Bucuresti
In SC DELOS IMPEX ’96 SRL the quality of the active pharmaceutical ingredient (API) for the finished product Colidem 50 – hydrosoluble powder is make according to European Pharmacopoeia, curent edition. The method for analysis use in this purpose is the compendial method „Colistine sulphate” in E.P. in current edition and represent a optimized variant, developed and validated „in house”.The parameters which was included in the methodology validation for chromatographic method are the follow: selectivity/specificity, linearity, range of linearity, limit of detection and limit of quantification, precision (repeatability-intra day, inter-day reproducibility), accuracy, robustness, stability solutions and system suitability.
Author: Maria Neagu Affiliation: SC DELOS IMPEX ’96 SRL
In SC DELOS IMPEX ’96 SRL the quality of the active pharmaceutical ingredient (API) for the finite product Tilodem 50 – hydrosoluble powder was accomplished in the respect of last European Pharmacopoeia. The method for analysis used in this purpose was the compendial method „Tylosin tartrate for veterinary use” in EurPh. in vigour edition and represent a variant developed and validation „in house”. The parameters which was included in the methodology validation for chromatographic method are the followings: Selectivity, Linearity, Linearity range, Detection and Quantification limits, Precision, Repeatability (intra day), Inter-Day Reproductibility, Accuracy, Robustness, Solutions’ stability and System suitability. According to the European Pharmacopoeia, the active pharmaceutical ingredient is consistent, in terms of quality, if it contains Tylosin A – minimum 80% and the amount of Tylosin A, B, C, D, at minimum 95% Identification and determination of each component separately (Tylosin A, B, C, D) is possible by chromatographic separation – HPLC. Validation of analytical methods is presented below.