TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.

Registration ID: IJNRD_182452

Published ID: IJNRD2208066

DOI: Click Here to Get

Priyanka Jha , Sunita Arya , Gulbahar

Con-current validation, Metformin Hydrochloride, Sustained Released , critical parameters, process validation

Validation is the process of establishment of documented evidence that the process, methods and procedure that are carried out will leads ti the expected results. Sustained release are the type of solid dosages form that is designed to release the drugs over an extended period of time to achieve the therapeutic levels. The aim of the present study is to perform concurrent process validation metformin Sustained release tablet to ensure optimization and reproducibility.to conduct the validation three consecutive batches were selected. All instruments required to carry out con-current validation were calibrated as per SOPs. All raw materials used in the manufacturing of the product were verified for the release status. Tablet was manufactured by wet granulation method. Granulation was excellent at 10 minutes .Drying was excellent at temperature of 50 ± 50C because %LOD was in limit . Blending was excellent at 8 minutes . For compression parameters like Average weight, Weight of 20 tablets, Hardness, Thickness, Diameter, Friability and Assay were according to specification.. All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly along with the hold time studies.All parameters at various stages of tablet manufacturing were as per specifications, so the process was validated properly.

Published Paper   E-Certificate

Priyanka Jha, Sunita Arya, & Gulbahar (August-2022). TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 7(8), 592-612. https://ijnrd.org/papers/IJNRD2208066.pdf

Volume 7 Issue 8, August-2022

Pages : 592-612

Paper Reg. ID: IJNRD_182452

Published Paper Id: IJNRD2208066

Downloads: 000121988

Research Area: Pharmacy

Country: Dehardun, Uttarakhand, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2208066.pdf

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