The aim of current study is quality control of L - Glutamic acid in supplement mixture before and after treatment with γ - ray. Microbiological methods, included in European Pharmacopoeia were used for examination of microbial purity of substance L - Glutamic acid. Abnormal content (1.5.10 -4 g) of bacteria and contaminants were identified mostly as non patogenic bacilli of Subtilis group. Patogenic contaminants as Enterobacteriaceae and Staphylococcus aureus were not found. Resistency factors show moderate ray sensitivity of the microorganisms. HPLC method was developed and applied and analytical parameters repeatability, limit of detection (LOD), limit of quantitation (LOQ) and linearity were studied and determined in accordance with ICH and European Pharmacopoeia requirements. For repeatability SD = 1.43, RDS = + 0.44. The obtained LOD is 10 μg and LOQ is 40 μg. The correlation coefficients is found to be 0.99746 at SD = + 3914.60 AU. There are no significant difference between content of L - Glutamic acid in supplement mixtures before (RDS = + 0.44 %) and after γ - ray treatment (RDS = + 0.082 %).

A study of the behaviour of L - Glutamic acid in the course of and after γ - Ray treatment / D., Obreshkova; D., Tsvetkova; I., Pencheva; Saso, Luciano; K., Ivanov. - In: INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES. - ISSN 0975-1491. - 4:SUPPL. 4(2012), pp. 117-120.

A study of the behaviour of L - Glutamic acid in the course of and after γ - Ray treatment

SASO, Luciano;
2012

Abstract

The aim of current study is quality control of L - Glutamic acid in supplement mixture before and after treatment with γ - ray. Microbiological methods, included in European Pharmacopoeia were used for examination of microbial purity of substance L - Glutamic acid. Abnormal content (1.5.10 -4 g) of bacteria and contaminants were identified mostly as non patogenic bacilli of Subtilis group. Patogenic contaminants as Enterobacteriaceae and Staphylococcus aureus were not found. Resistency factors show moderate ray sensitivity of the microorganisms. HPLC method was developed and applied and analytical parameters repeatability, limit of detection (LOD), limit of quantitation (LOQ) and linearity were studied and determined in accordance with ICH and European Pharmacopoeia requirements. For repeatability SD = 1.43, RDS = + 0.44. The obtained LOD is 10 μg and LOQ is 40 μg. The correlation coefficients is found to be 0.99746 at SD = + 3914.60 AU. There are no significant difference between content of L - Glutamic acid in supplement mixtures before (RDS = + 0.44 %) and after γ - ray treatment (RDS = + 0.082 %).
2012
l-glutamic acid
01 Pubblicazione su rivista::01a Articolo in rivista
A study of the behaviour of L - Glutamic acid in the course of and after γ - Ray treatment / D., Obreshkova; D., Tsvetkova; I., Pencheva; Saso, Luciano; K., Ivanov. - In: INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES. - ISSN 0975-1491. - 4:SUPPL. 4(2012), pp. 117-120.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/691860
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