Research Article | Open Access
Vol. 9 No. 04 (2022)
|
Page No.: 6073-6081 |
https://doi.org/10.18535/ijmsci/v9i04.06
Research Scholar, Department of Pharmaceutical chemistry, Shrinathji Institute of pharmacy, upali oden, Nathdwara, dist-Rajsamand (Raj.)-313301 INDIA
Professor, Department of Pharmaceutical chemistry, Shrinathji Institute of pharmacy, upali oden, Nathdwara, dist-Rajsamand (Raj.)-313301 INDIA
Principal, Department of Pharmaceutical chemistry, Shrinathji Institute of pharmacy, upali oden, Nathdwara, dist-Rajsamand (Raj.)-313301 INDIA
Abstract
All the three batches resulted in granules with desired flow and compaction which is evident from the data of compressed tablets. At compression stage Weight parameters and Speed parameters evaluated and found within Specified limit as well as, The Statistical analysis process performance is high capable, Data is normal and Z bench value also give assurance that process remains in state of control (Process validation state) during manufacturing of Sevelamer Hydrochloride film coated tablets, 800 mg. Coating process proven as validated from the weight build up data of tablets as validation data provided for after 50% coating, 75% coating and 100% coating and found in accordance with process validation protocol. Finished product result was evidence of Weight gain while the inspection activity as this material is in very high hygroscopic in nature. However results found within specified limit.
Keywords:
Z bench value, Sevelamer Hydrochloride, Process validation, cGMP.
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Copyright © 2022 Aditya Thakur D. B. Joshi R. S. Bhadauria this is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
This work is licensed under a Creative Commons Attribution 4.0 International License.
