Uji Stabilitas Obat Sediaan Tablet: Prinsip, Pedoman ICH Q1, dan Parameter Kritis

This article provides a comprehensive review of drug stability testing, specifically focusing on tablet dosage forms. It elucidates the fundamental principles, the critical role of ICH Q1 guidelines, and essential parameters evaluated during stability studies, including physical, chemical, and microbiological aspects. The discussion covers various types of stability studies, standardized storage conditions, and the interpretation of results for determining shelf life and ensuring product quality. Relevant case studies on tablet stability are also integrated to illustrate practical applications. This review aims to provide a structured overview of stability testing methodologies and their significance in pharmaceutical development and quality assurance.

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Publication Details

Journal
Obat
Published
2025-06-16
DOI
https://doi.org/10.61132/obat.v3i4.1507
Primary Topic
Agricultural and Biological Research
Type
article
Field-Weighted Citation Impact
0.00
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article

Uji Stabilitas Obat Sediaan Tablet: Prinsip, Pedoman ICH Q1, dan Parameter Kritis

Nor Latifah, Jannatun Nisa, Nicky Saputra
Obat
Agricultural and Biological Research
article

Uji Stabilitas Obat Sediaan Tablet: Prinsip, Pedoman ICH Q1, dan Parameter Kritis

Nor Latifah, Jannatun Nisa, Nicky Saputra
article en

Abstract

This article provides a comprehensive review of drug stability testing, specifically focusing on tablet dosage forms. It elucidates the fundamental principles, the critical role of ICH Q1 guidelines, and essential parameters evaluated during stability studies, including physical, chemical, and microbiological aspects. The discussion covers various types of stability studies, standardized storage conditions, and the interpretation of results for determining shelf life and ensuring product quality. Relevant case studies on tablet stability are also integrated to illustrate practical applications. This review aims to provide a structured overview of stability testing methodologies and their significance in pharmaceutical development and quality assurance.

ObatVol. 3(4)
Openalex Percentile: Top 78%
Agricultural and Biological Research
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Uji Stabilitas Obat Sediaan Tablet: Prinsip, Pedoman ICH Q1, dan Parameter Kritis — Nor Latifah, Jannatun Nisa, et al. · Obat (2025) | TGRS Research Map | TGRS