Formulation and Process Validation of Clopidogrel Bisulfate 300mg Tablet

Authors

  • Sravani Shilpa K Department of Pharmaceutics, Annai Veilankannis Pharmacy College, Chennai, T. N., India.
  • Meka Anand Kumar Department of Pharmaceutics, Annai Veilankannis Pharmacy College, Chennai, T. N., India.
  • Senthil Kumar M Department of Pharmaceutics, G. Pulla Reddy College of Pharmacy, Hyderabad, A.P.,India.

Abstract

The purpose of study is to formulate and process validation is to create a robust formulation and to validate all the critical parameters challenged in manufacturing process like dry mixing, blending, lubrication, compression, coating and packing. By comparing the results of above challenged parameters, it shown that all the results of three batch's had met the pre determine specification and FDA requirement. Finally by seeing the results we can say that the process followed was correct and are as per c GMP requirements.

Keywords:

Clopidogrel bisulfate, Blending, Lubrication, Mannitol, formulating, Process validation

References

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Published

2025-01-01
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Issue

Vol. 3 No. 4 (2011): Volume 3,Issue4

Section

Articles