Terbinafine Tablet Quality Control Test Report and Pharmacology: Compliance with Pharmacopeial Standards
Year: 2024
Type: article
Abstract: This comprehensive report evaluates the quality control and pharmacological profile of Terbinafine tablets, ensuring adherence to Indian Pharmacopoeia (IP) 2022 standards. 1. Identity: Thin Layer Chromatography (TLC) confirmed the presence of Terbinafine. 2. Physical Characteristics: Tablets met IP 2022 specifications for description and disintegration time (≤15 minutes). 3. Chemical Purity: Assay results showed 97.06% of labeled amount. 4. Performance: Dissolution exceeded 75% in 30 minutes. 5.Microbial limits. 6. Assay: 90-110% of labeled amount. Pharmacological Assessment: 1. Mechanism: The synthesis of fungal cell membranes is disrupted by squalene epoxidase inhibition. 2. Antimicrobial Spectrum: Works well against molds, yeasts, and dermatophytes. 3. Pharmacokinetics: Hepatic metabolism, wide tissue distribution, and quick absorption. Limits of Microbes: met IP 2022 requirements for the absence of designated pathogens, total yeast and mold count (TYMC), and total aerobic microbiological count (TAMC). Limits of Microbes.
Author: Aditya Mane*, Anirudha Patil, Tejashri Kamble, Dr. Nilesh Chougule
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6911779965
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