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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT. |
| Authors Name: | Priyanka Jha , Sunita Arya , Gulbahar |
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IJNRD_182452
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| Published Paper Id: | IJNRD2208066 |
| Published In: | Volume 7 Issue 8, August-2022 |
| DOI: | |
| Abstract: | 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. |
| Keywords: | Con-current validation, Metformin Hydrochloride, Sustained Released , critical parameters, process validation |
| Cite Article: | "TO PERFORM PROCESS VALIDATION (CONCURRENT) OF METFORMIN HYDROCHLORIDE SUSTAINED RELEASE TABLET TO ENSURE OPTIMISED REPRODUCIBILITY OF PRODUCT.", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.7, Issue 8, page no.592-612, August-2022, Available :http://www.ijnrd.org/papers/IJNRD2208066.pdf |
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2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID:IJNRD2208066 Registration ID: 182452 Published In: Volume 7 Issue 8, August-2022 DOI (Digital Object Identifier): Page No: 592-612 Country: Dehardun, Uttarakhand, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2208066 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2208066 |
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
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