The quality of the final product especially with respect to the content of uniformity is primarily determined by homogenicity of mixture. Validation of process has become mandatory in U.S. as per GMP regulations and also by a court action of 1993. Present study involves validation of mixing, drying and compression process for the manufacturing of Paracetamol Tablet I.P.(500 mg) Paracetamol was mixed with starch in a mass mixer as per the developed formula. Samples were withdrawn from predetermined locations in the mixer at different time intervals 4 to 16 min and assayed spectrophotometrically. The dried granules were mixed with lubricants consisting of Talcum, Magnesium Stearate and Sodium Lauryl Sulphate. The samples were withdrawn from different predetermined locations and assayed for Paracetamol content. From analysis of data that 10 min was found to be optimum mixing time during mixing process. Time required for 3 Kg of material was 29 to 30 minutes for drying studies and different compression parameters were comply with requirements of I.P. 96. Self developed software Pro-Vali was found to be useful in process validation studies.

About the Author

Dr. Dheeraj T. Baviskar, M.Pharm, Ph.D.,D.B.M., A.I.C studied Post Doctarate (2010), Ph.D. (2007) and M.Pharm (Quality Assurance, 2000). Professor and Principal at Institute of Pharmaceutical Education, Boradi,Tal- Shirpur, Dist-Dhule,(M.S.)India. Twelve years experiance at UG & PG level. Approved Supervisor for PG & Ph.D. students.

"About this title" may belong to another edition of this title.

Store Description

I mainly carry imported books from South East Asia / South Asia for readers of all Age Groups.

Visit Seller's Storefront

Seller's business information

PLETOS INC
6931 51st Avenue, WOODSIDE, Woodside, NY, 11377, U.S.A.

Sale & Shipping Terms

Terms of Sale

We accept return for those books which are received damaged. Though we take appropriate care in packing to avoid such situation.

Shipping Terms

Shipping rates within U.S.A.

Shipping rates within U.S.A.
Order quantity	12 to 19 business days	12 to 14 business days
First item	US$ 3.99	US$ 6.99

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.