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Research Paper | Pharmaceutical Science | India | Volume 8 Issue 9, September 2019
Process Validation of Labetalol Hydrochloride 200 Mg Tablets
Abstract: Validation is a very crucial step involved in achieving and maintaining the quality of any drug products. The main objective of my research is to study the process validation of labetalol hydrochloride 200 mg. The study untaken here provides the assurance that the manufacturing procedure is suitable for intended purpose and the product consistently meets predetermined specifications and quality attributes, as per specified master formula record. The process validation of labetalol hydrochloride tablet of dosage 200 mg completed for 3 back to back bunches of batch no.1, batch no.2, batch no.3which include the validation of critical steps of manufacturing constituting dispensing, sifting, dry mixing, drying blending, compression and coating. During this process all the critical control parameters are observed such as uniformity in blend, bulk density, tapped density, flow property, uniformity of content, uniformity of dosage unit, average weight, thickness, hardness, friability, disintegration time, dissolution test, and assay. The results obtained of the three batches were found within limits. Therefore the product with require specification can consistently obtained.
Keywords: Key words - Labetalol hydrochloride, process validation, quality assurance, performance qualification, standard operating procedure
Edition: Volume 8 Issue 9, September 2019,
Pages: 674 - 678