Analisis Kompaaratif Stabilitas Kimia dan Fisika Paracetamol pada Sediaan Padat dan Cair

Paracetamol is one of the most widely used analgesic-antipyretic drugs and is available in various formulations, including solid tablets and liquid syrups, which differ significantly in long-term stability. This review analyzes data from ten journal studies (2013–2024) comparing the stability of paracetamol in different dosage forms. A literature review method was employed to assess physical and chemical stability under various storage conditions. Solid dosage forms, such as tablets, generally exhibit excellent long-term stability. When stored in sealed packaging at 30 °C/75% RH, tablets maintained potency and low impurity levels for up to five years. In contrast, liquid formulations, especially oral suspensions, degrade more rapidly once opened. For example, an opened Panadol® suspension retained acceptable quality for about five months under optimal conditions (refrigerated, protected from light) and degraded faster (around 3.5 months) under high temperatures. The main degradation product, p-aminophenol (PAP), remained below 0.005% in tablets but exceeded the 0.1% limit in most opened suspensions.Formulation factors, including pH and cosolvent use (e.g., glycerin, PEG 400), significantly affected liquid stability. Syrups with PEG 400 + glycerin maintained stable pH levels (5.6–6.8). In conclusion, solid forms are more stable than liquids, and careful formulation and adherence to storage guidelines are essential to ensure product quality.

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Publication Details

Journal
Jurnal Riset Ilmu Kesehatan Umum dan Farmasi
Published
2025-07-04
DOI
https://doi.org/10.57213/jrikuf.v3i3.773
Primary Topic
Cancer and biochemical research
Type
article
Field-Weighted Citation Impact
0.00
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article

Analisis Kompaaratif Stabilitas Kimia dan Fisika Paracetamol pada Sediaan Padat dan Cair

Anisa Anisa, Nor Latifah, Annisa Normiani Putri
Jurnal Riset Ilmu Kesehatan Umum dan Farmasi
Cancer and biochemical research
article

Analisis Kompaaratif Stabilitas Kimia dan Fisika Paracetamol pada Sediaan Padat dan Cair

Anisa Anisa, Nor Latifah, Annisa Normiani Putri
article en

Abstract

Paracetamol is one of the most widely used analgesic-antipyretic drugs and is available in various formulations, including solid tablets and liquid syrups, which differ significantly in long-term stability. This review analyzes data from ten journal studies (2013–2024) comparing the stability of paracetamol in different dosage forms. A literature review method was employed to assess physical and chemical stability under various storage conditions. Solid dosage forms, such as tablets, generally exhibit excellent long-term stability. When stored in sealed packaging at 30 °C/75% RH, tablets maintained potency and low impurity levels for up to five years. In contrast, liquid formulations, especially oral suspensions, degrade more rapidly once opened. For example, an opened Panadol® suspension retained acceptable quality for about five months under optimal conditions (refrigerated, protected from light) and degraded faster (around 3.5 months) under high temperatures. The main degradation product, p-aminophenol (PAP), remained below 0.005% in tablets but exceeded the 0.1% limit in most opened suspensions.Formulation factors, including pH and cosolvent use (e.g., glycerin, PEG 400), significantly affected liquid stability. Syrups with PEG 400 + glycerin maintained stable pH levels (5.6–6.8). In conclusion, solid forms are more stable than liquids, and careful formulation and adherence to storage guidelines are essential to ensure product quality.

Jurnal Riset Ilmu Kesehatan Umum dan FarmasiVol. 3(3)
Universitas Muhammadiyah Banjarmasin
Openalex Percentile: Top 75%
Cancer and biochemical research
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