The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL

The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL

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....

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Bibliographic Details
Main Authors: Maria Neagu, Cristina Marinescu, Carmen Popescu
Format: Article
Language:English
Published: Romanian National Association of the Veterinary Products Manufacturers 2011-06-01
Series:Medicamentul Veterinar
Subjects:
Colistine sulphate
Analytical method validation (HPLC)
Identification
Assay
Related
Online Access:http://www.veterinarypharmacon.com/docs/937-2011-ART.3.eng.pdf
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spelling doaj-3920b314f9ba4735ad4d83cffa604ca62021-06-02T01:29:12ZengRomanian National Association of the Veterinary Products ManufacturersMedicamentul Veterinar1843-95272069-24632011-06-01514163The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRLMaria Neagu,Cristina Marinescu,Carmen PopescuIn 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.http://www.veterinarypharmacon.com/docs/937-2011-ART.3.eng.pdfColistine sulphateAnalytical method validation (HPLC)IdentificationAssayRelated
collection DOAJ
language English
format Article
sources DOAJ
author Maria Neagu,
Cristina Marinescu,
Carmen Popescu
spellingShingle Maria Neagu,
Cristina Marinescu,
Carmen Popescu
The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
Medicamentul Veterinar
Colistine sulphate
Analytical method validation (HPLC)
Identification
Assay
Related
author_facet Maria Neagu,
Cristina Marinescu,
Carmen Popescu
author_sort Maria Neagu,
title The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
title_short The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
title_full The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
title_fullStr The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
title_full_unstemmed The validation of the analytical method (HPLC), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product Colidem 50 – hydrosoluble powder, in SC DELOS impex ‘96 SRL
title_sort validation of the analytical method (hplc), use for identification and assay of the pharmaceutical active ingredient, colistine sulphate and the finished product colidem 50 – hydrosoluble powder, in sc delos impex ‘96 srl
publisher Romanian National Association of the Veterinary Products Manufacturers
series Medicamentul Veterinar
issn 1843-9527
2069-2463
publishDate 2011-06-01
description 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.
topic Colistine sulphate
Analytical method validation (HPLC)
Identification
Assay
Related
url http://www.veterinarypharmacon.com/docs/937-2011-ART.3.eng.pdf
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