Analytical Method Development For Drugs Including Stability Studies
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To produce quality drug, quality assurance at every stage becomes the most important process now a days. The globalization phenomenon has compelled the industry to review the technology to meet the international standards while maintaining the competition. The current ICH guidelines require that analysis of stability test samples should be done by using SIAM and validated after stress testing on the drug under a variety of conditions, including hydrolysis (at various pH), oxidation, photolysis and thermal degradation. Therefore the development of reliable, accurate, precise, validated, stabili...
To produce quality drug, quality assurance at every stage becomes the most important process now a days. The globalization phenomenon has compelled the industry to review the technology to meet the international standards while maintaining the competition. The current ICH guidelines require that analysis of stability test samples should be done by using SIAM and validated after stress testing on the drug under a variety of conditions, including hydrolysis (at various pH), oxidation, photolysis and thermal degradation. Therefore the development of reliable, accurate, precise, validated, stability indicating analytical method, suitable for routine determination for the quality control is both important and challenging for the analytical chemist.This book contains detailed account of analytical methods for thiocolchicoside and its combination with proposed stability protocol of thiocolchicoside towards acidic,alkaline, oxidative, UV and photo degradation processes. I hope that this book will fulfill the needs of research students of pharmacy and science, faculties and help analytical chemist to develop the quality at every stage in pharmaceutical products at industrial level.
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