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- They are validated, quantitative test methods that can detect changes with time in the chemical, physical or microbiological properties of Drug Substance or Drug Product They are specific, so that the quantity of Active products and other components of interest can be accurat ely measured without interference in the material tested.
www.researchgate.net/publication/322287641_Stability_Indicating_Analytical_Methods_SIAMS
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What is a stability indicating assay (Siam)?
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Jun 15, 2014 · The main objective of a stability indicating method is to monitor results during stability studies in order to guarantee safety, efficacy and quality. It represents also a powerful tool when investigating out-of-trend (OOT)[2] or out-of-specification (OOS) [3] results in quality control processes.
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Jun 15, 2002 · Thus ‘Specific stability-indicating assay method (Specific SIAM)’ can be defined as ‘a method that is able to measure unequivocally the drug(s) in the presence of all degradation products, excipients and additives, expected to be present in the formulation.’
- Monika Bakshi, Saranjit Singh
- 2002
Jan 2, 2018 · They are validated, quantitative test methods that can detect changes with time in the chemical, physical or microbiological properties of Drug Substance or Drug Product
Jun 15, 2002 · This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted.
- Monika Bakshi, Saranjit Singh
- 2002
Apr 15, 2014 · Thus ‘Specific stability-indicating assay method (Specific SIAM)’ can be defined as “a method that is able to measure unequivocally the drug(s) in the presence of all degradation products, excipients and additives, expected to be present in the formulation.
- Uday Deokate, Anjali Macchindra Gorde
- 2014
Jan 1, 2018 · The assay is a specific and stability-indicating test to determine the potency (content) of the drug product. When a nonspecific assay (e.g., titration) is justified, other supporting analytical procedures should ensure that any interfering species can be detected.
Mar 27, 2021 · Stability indicating assay describes a technique which is used to analyse the stability of drug substance or active pharmaceutical ingredient (API) in bulk drug and pharmaceutical products. Stability indicating assay must be properly validated as per ICH guidelines.
Quantify DNA, RNA, or Protein with Accuracy, Specificity and High Sensitivity. Dyes Bind Selectively to DNA, RNA, or Protein – Assays More Sensitive Than UV Absorbance.
