Investigation of the chemical equivalence of the trypanocidal products, Samorin® and Veridium
A procedure for the evaluation of chemical equivalence of proprietary formulations of isometamidium is described. The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substances and determination of the inorganic impurity, ammonium chloride, using a...
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| Veröffentlicht in: | Journal of pharmaceutical and biomedical analysis 1999-10, Vol.21 (1), p.1-7 |
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| container_title | Journal of pharmaceutical and biomedical analysis |
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| creator | Tettey, J.N.A. Skellern, G.G. Grant, M.H. Midgley, J.M. |
| description | A procedure for the evaluation of chemical equivalence of proprietary formulations of isometamidium is described. The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substances and determination of the inorganic impurity, ammonium chloride, using a modification of the Berthelot (Indophenol) reaction. Application of these procedures to analyses of commercially available sachets from four different batches of Samorin® and four different batches of Veridium® has demonstrated that there are marked qualitative and quantitative differences between batches from these two sources. Whilst Samorin® samples showed inter-batch consistency of composition, there was considerable inter-batch variation between the samples of Veridium®. |
| doi_str_mv | 10.1016/S0731-7085(99)00110-7 |
| format | Article |
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The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substances and determination of the inorganic impurity, ammonium chloride, using a modification of the Berthelot (Indophenol) reaction. Application of these procedures to analyses of commercially available sachets from four different batches of Samorin® and four different batches of Veridium® has demonstrated that there are marked qualitative and quantitative differences between batches from these two sources. 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The method combines the analysis of the principal component (isometamidium), HPLC profiling of related substances and determination of the inorganic impurity, ammonium chloride, using a modification of the Berthelot (Indophenol) reaction. Application of these procedures to analyses of commercially available sachets from four different batches of Samorin® and four different batches of Veridium® has demonstrated that there are marked qualitative and quantitative differences between batches from these two sources. Whilst Samorin® samples showed inter-batch consistency of composition, there was considerable inter-batch variation between the samples of Veridium®.</description><subject>Ammonium Chloride - analysis</subject><subject>Ammonium chloride determination</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiparasitic agents</subject><subject>Biological and medical sciences</subject><subject>Chemical equivalence</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Drug Industry</subject><subject>High performance liquid chromatography</subject><subject>Isometamidium</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Phenanthridines - analysis</subject><subject>Samorin</subject><subject>Trypanocidal Agents - analysis</subject><subject>Trypanocidal Agents - chemistry</subject><subject>Veridium</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkM1u1DAQgC3Uim4LjwDKAVVUauhMnNjxqUJVC5UqcViKOGF57Qk1ys_WTlbqS_EQPFm9P0BvPY00883fx9gbhA8IKM7mIDnmEurqvVInAIiQyxdshrXkeSHK73ts9g85YIcx_gKAClX5kh0gSEAFcsZ-XPcriqP_aUY_9NnQZOMdZfaOOm9Nm9H95Fempd7S39oYHpamH6x3qb4Mg5vsGE-zuemG4Ps_vzPTu-wbBe_81L1i-41pI73exSN2e3X59eJzfvPl0_XFx5vccgVj7qgwi0VDVBcFlUTcFQsjraEqpUXDVUOlNEJxFGh5XVbcAUdXgnOIjkt-xI63c9NB91N6SHc-Wmpb09MwRS1UWfJa8ARWW9CGIcZAjV4G35nwoBH0WqzeiNVra1opvRGr1wve7hZMi47ck66tyQS82wEmJnNNML318T-nhEIhEna-xSjZWHkKOlq_1ut8IDtqN_hnLnkEJxmXSw</recordid><startdate>19991001</startdate><enddate>19991001</enddate><creator>Tettey, J.N.A.</creator><creator>Skellern, G.G.</creator><creator>Grant, M.H.</creator><creator>Midgley, J.M.</creator><general>Elsevier B.V</general><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19991001</creationdate><title>Investigation of the chemical equivalence of the trypanocidal products, Samorin® and Veridium</title><author>Tettey, J.N.A. ; Skellern, G.G. ; Grant, M.H. ; Midgley, J.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-de2abbfee822e4ee3d2ba7cae5abb6f39fe47a693161c38453d031d40dd11d373</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Ammonium Chloride - analysis</topic><topic>Ammonium chloride determination</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiparasitic agents</topic><topic>Biological and medical sciences</topic><topic>Chemical equivalence</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Drug Industry</topic><topic>High performance liquid chromatography</topic><topic>Isometamidium</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenanthridines - analysis</topic><topic>Samorin</topic><topic>Trypanocidal Agents - analysis</topic><topic>Trypanocidal Agents - chemistry</topic><topic>Veridium</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tettey, J.N.A.</creatorcontrib><creatorcontrib>Skellern, G.G.</creatorcontrib><creatorcontrib>Grant, M.H.</creatorcontrib><creatorcontrib>Midgley, J.M.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tettey, J.N.A.</au><au>Skellern, G.G.</au><au>Grant, M.H.</au><au>Midgley, J.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Investigation of the chemical equivalence of the trypanocidal products, Samorin® and Veridium</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>1999-10-01</date><risdate>1999</risdate><volume>21</volume><issue>1</issue><spage>1</spage><epage>7</epage><pages>1-7</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>A procedure for the evaluation of chemical equivalence of proprietary formulations of isometamidium is described. 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| ispartof | Journal of pharmaceutical and biomedical analysis, 1999-10, Vol.21 (1), p.1-7 |
| issn | 0731-7085 1873-264X |
| language | eng |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Ammonium Chloride - analysis Ammonium chloride determination Antibiotics. Antiinfectious agents. Antiparasitic agents Antiparasitic agents Biological and medical sciences Chemical equivalence Chromatography, High Pressure Liquid - methods Drug Industry High performance liquid chromatography Isometamidium Medical sciences Pharmacology. Drug treatments Phenanthridines - analysis Samorin Trypanocidal Agents - analysis Trypanocidal Agents - chemistry Veridium |
| title | Investigation of the chemical equivalence of the trypanocidal products, Samorin® and Veridium |
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