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1. • •  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.
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     (PDF) Stability Indicating Analytical Methods (SIAMS)

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   What is a stability indicating assay (Siam)?

   • The stability-indicating assay is a method that is employed for the analysis of stability samples in pharmaceutical industry. With the advent of International Conference on Harmonisation (ICH) guidelines, the requirement of establishment of stability-indicating assay method (SIAM) has become more clearly mandated.

   REVIEW ON STABILITY INDICATING ASSAY METHODS (SIAMS)

   www.pharmatutor.org/articles/review-stability-indicating-assay-methods-siams

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   What is a 'specific Siam' assay?

   • It is for this reason that assay methods prescribed in the monographs have classically and primarily been designed to be stability-specific (‘Specific SIAM’) by nature, and not meant to be selective to each decomposition product and other constituents in the drug substance or formulation.

   Development of validated stability-indicating assay methods—critical

   www.sciencedirect.com/science/article/pii/S073170850200047X

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   How do you determine the accuracy of a SIAM?

   • However, a better method of determining accuracy of a SIAM is by spiking the drug in a mixture of degraded solutions . As far as the precision is concerned, there are no special requirements for stability-indicating methods and the same procedure as advocated for normal assay methods can be applied.

   Development of validated stability-indicating assay methods—critical

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   What is a SIAM synthesis method?

   • STE PS INVOLVED DURING THE DEVELOPMENT OF STABILITY– of its synthesis route. As per the FDA regulations, a SIAM is defined as a methodologies for stability studies be stability indicating. There are three components necessary for implement ing a SIAM. 1. Sample generation, 2. Method development, 3. Method va lidation used to develop the SIAM.

   (PDF) Stability Indicating Analytical Methods (SIAMS

   www.researchgate.net/publication/322287641_Stability_Indicating_Analytical_Methods_SIAMS

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   When did Siam become a requirement for stability studies?

   • The reference to SIAM appeared in 2001 in Brazil, as one of the requirements for stability studies: all testing parameters and methods describing content assay, impurities and physical characteristics should provide documented evidence that methods indicate product stability .

   Brazilian requirements for stability indicating methods

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   What is a 'specific Siam'?

   • A ‘Specific SIAM’, if it is less cumbersome and costly, and is proved to give the same results as a ‘Selective SIAM’ can be used for post-approval follow-up stability testing and also for analysis of market surveillance and returned samples.

   Development of validated stability-indicating assay methods—critical

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3. www.pharmatutor.org › articles › review-stabilityREVIEW ON STABILITY INDICATING ASSAY METHODS (SIAMS)

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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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     The resulting microparticles obtained by solvent evaporation...

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4. www.sciencedirect.com › science › articleDevelopment of validated stability-indicating assay methods ...

   www.sciencedirect.com › science › article

   Jun 15, 2002 · A ‘Specific SIAM’, if it is less cumbersome and costly, and is proved to give the same results as a ‘Selective SIAM’ can be used for post-approval follow-up stability testing and also for analysis of market surveillance and returned samples.

   • Author: Monika Bakshi, Saranjit Singh

   • Publish Year: 2002

5. www.pharmatutor.org › articles › forced-degradationFORCED DEGRADATION AND STABILITY TESTING ... - PharmaTutor

   www.pharmatutor.org › articles › forced-degradation

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   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.

   • Author: Uday Deokate, Anjali Macchindra Gorde

   • Publish Year: 2014

6. pubmed.ncbi.nlm.nih.gov › 12049968Development of validated stability-indicating assay methods ...

   pubmed.ncbi.nlm.nih.gov › 12049968

   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.

   • Author: Monika Bakshi, Saranjit Singh

   • Publish Year: 2002

7. www.researchgate.net › publication › 322287641(PDF) Stability Indicating Analytical Methods (SIAMS)

   www.researchgate.net › publication › 322287641

   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

8. www.sciencedirect.com › science › articleBrazilian requirements for stability indicating methods

   www.sciencedirect.com › science › article

   Jan 1, 2018 · In this context, stability indicating analytical methods (SIAM) appears as a regulatory requirement to detect common observed impurities and those likely to appear during product shelf-life due to degradation.

9. www.sciencedirect.com › science › articleChoices of chromatographic methods as stability indicating ...

   www.sciencedirect.com › science › article

   Mar 1, 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.