MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN
Ascomicin is an antibacterial unguent for treatment of local infections of skin, eyes, outer ear, in cattle, sheep, pig, dog and cat. The product contains two active substances: benzylpenicillin potassium (Penicillin G potassium) and streptomycin sulphate. The main characteristic of commercial produ...
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| Format: | Article |
| Language: | English |
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Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar
2016-12-01
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| Series: | Medicamentul Veterinar |
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| Online Access: | http://www.veterinarypharmacon.com/docs/1718-2016_VD_10(2)_ART.7_ENG.pdf |
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| author | Viviana Ciuca Victorita Burghelea V.V. Safta Despina Nita Luciana Paraschiv |
| author_facet | Viviana Ciuca Victorita Burghelea V.V. Safta Despina Nita Luciana Paraschiv |
| author_sort | Viviana Ciuca |
| collection | DOAJ |
| description | Ascomicin is an antibacterial unguent for treatment of local infections of skin, eyes, outer ear, in cattle, sheep, pig, dog and cat. The product contains two active substances: benzylpenicillin potassium (Penicillin G potassium) and streptomycin sulphate. The main characteristic of commercial product is benzylpenicillin potassium and streptomycin sulphate potency. The potency is estimated by comparing the inhibition of growth of sensitive micro-organisms produced by known concentrations of the antibiotic to be examined and a reference substance. The validation study aims to demonstrate the determination of
the potency of benzylpenicillin potassium and streptomycin sulphate, it is an appropriate analytical method, reproducible and meets the quality requirements of Ascomicin product. The paper establishes the performance characteristics of the method considered and identify the factors that influence these
characteristics. The diameters of inhibition zones, directly proportional to the logarithm of the concentration of the antibiotic used for the assay, measured and calculated using statistical methods (Combistats Soft). The assay is designed in such a way that the mathematical model on which the potency equation is based can be proved to be valid. A parallel-line model is chosen. The two log dose response lines of the preparation under examination and the standard preparation are parallel; they are
rectilinear over the range of doses used in the calculation. These conditions are verified by validity tests for a given probability (P = 0.05). The test is not valid unless the confidence limits (P = 0.95) are not less than 50 per cent and not more than 200 per cent of the estimated potency. The estimated potency is not less than 95 per cent and not more than 105 per cent of the stated potency. The stated potency is not less than 19400 international units/g benzylpenicillin potassium and 13960 international units/g streptomycin sulphate. The validation procedure includes details on protocol working to determine the potency of benzylpenicillin potassium and streptomycin sulphate, validation criteria, experimental results, mathematical modeling for determining the potency, interlaboratory comparisons. |
| format | Article |
| id | doaj-art-040ef39063a145b28f390b9186e2cd85 |
| institution | Kabale University |
| issn | 1843-9527 2069-2463 |
| language | English |
| publishDate | 2016-12-01 |
| publisher | Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar |
| record_format | Article |
| series | Medicamentul Veterinar |
| spelling | doaj-art-040ef39063a145b28f390b9186e2cd852025-08-20T03:34:20ZengAsociaţia Naţională a Fabricanţilor de Produse de Uz VeterinarMedicamentul Veterinar1843-95272069-24632016-12-011026574MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICINViviana Ciuca 0Victorita Burghelea1V.V. Safta2Despina Nita3Luciana Paraschiv4NS Pasteur Institute SA, Bucharest, RomaniaNS Pasteur Institute SA, BucharestPolytechnic University of BucharestNS Pasteur Institute SA, BucharestNS Pasteur Institute SA, BucharestAscomicin is an antibacterial unguent for treatment of local infections of skin, eyes, outer ear, in cattle, sheep, pig, dog and cat. The product contains two active substances: benzylpenicillin potassium (Penicillin G potassium) and streptomycin sulphate. The main characteristic of commercial product is benzylpenicillin potassium and streptomycin sulphate potency. The potency is estimated by comparing the inhibition of growth of sensitive micro-organisms produced by known concentrations of the antibiotic to be examined and a reference substance. The validation study aims to demonstrate the determination of the potency of benzylpenicillin potassium and streptomycin sulphate, it is an appropriate analytical method, reproducible and meets the quality requirements of Ascomicin product. The paper establishes the performance characteristics of the method considered and identify the factors that influence these characteristics. The diameters of inhibition zones, directly proportional to the logarithm of the concentration of the antibiotic used for the assay, measured and calculated using statistical methods (Combistats Soft). The assay is designed in such a way that the mathematical model on which the potency equation is based can be proved to be valid. A parallel-line model is chosen. The two log dose response lines of the preparation under examination and the standard preparation are parallel; they are rectilinear over the range of doses used in the calculation. These conditions are verified by validity tests for a given probability (P = 0.05). The test is not valid unless the confidence limits (P = 0.95) are not less than 50 per cent and not more than 200 per cent of the estimated potency. The estimated potency is not less than 95 per cent and not more than 105 per cent of the stated potency. The stated potency is not less than 19400 international units/g benzylpenicillin potassium and 13960 international units/g streptomycin sulphate. The validation procedure includes details on protocol working to determine the potency of benzylpenicillin potassium and streptomycin sulphate, validation criteria, experimental results, mathematical modeling for determining the potency, interlaboratory comparisons.http://www.veterinarypharmacon.com/docs/1718-2016_VD_10(2)_ART.7_ENG.pdfBenzylpenicilin potassiumstreptomycin sulphatemicrobiological methodCombistats Softestimated potency |
| spellingShingle | Viviana Ciuca Victorita Burghelea V.V. Safta Despina Nita Luciana Paraschiv MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN Medicamentul Veterinar Benzylpenicilin potassium streptomycin sulphate microbiological method Combistats Soft estimated potency |
| title | MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN |
| title_full | MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN |
| title_fullStr | MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN |
| title_full_unstemmed | MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN |
| title_short | MATHEMATICAL MODELING FOR BENZYLPENICILIN POTASSIUM AND STREPTOMYCIN SULPHATE POTENCY DETERMINATION OF ASCOMICIN |
| title_sort | mathematical modeling for benzylpenicilin potassium and streptomycin sulphate potency determination of ascomicin |
| topic | Benzylpenicilin potassium streptomycin sulphate microbiological method Combistats Soft estimated potency |
| url | http://www.veterinarypharmacon.com/docs/1718-2016_VD_10(2)_ART.7_ENG.pdf |
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