International Journal of Advanced Multidisciplinary Research and Studies
Volume 3, Issue 4, 2023
Ensuring Tigecycline Drug Quality: An In-depth Exploration of Assay and Related Substances
Author(s): Saurabh K Shukla, Varj N Patel, Cheris P Patel
Abstract:
To study assay and related substance of Tigecycline in pharmaceutical dosage form. Studying of assay and related impurity substances in Tigecycline. The results of the assay and related substances should be reported in the appropriate units of measurement, along with the method used, validation data, and any relevant calculations. The results should be compared against the acceptance criteria specified in the applicable pharmacopoeial monograph or in-house specification. Based on the results obtained, a conclusion can be drawn regarding the quality of the Tigecycline in the dosage form. If the results meet the acceptance criteria, the dosage form can be considered to be of acceptable quality. If not, corrective actions should be taken to improve the quality of the product.
Keywords: Assay, Tigecycline, Pharmaceutical Dosage Form, Pharmacopoeia
Pages: 981-984
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