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A Literature Study of IPQC (In Process Quality Control) tests and FDF (Finished Dosage Form) tests for Parenteral Dosage forms taking Adicovil IV Ampoule as an Example.

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Abstract

This study was conducted to evaluate both the in-process quality control tests as well as the finished dosage form tests for a parenteral product. Furthermore, all the processes from the purchase of API to marketing of product were studied. A batch of Adicovil was taken Adicovil was taken as an example, it is small volume parenteral of 2ml ampoule that is studied to evaluate its efficacy and stability by performing chemical and physical tests. IPQC tests for type I glass includes powder glass test, while for water for injection they are pH, acidity & alkalinity, non-volatile matter, ammonium ions, non-oxidizable matter, sterility and pyrogen test. Test for finished dosage form of Adicovil are identification, leaker test, clarity test, sterility, pyrogen test, BET, deliverable volume and determination of volume of injection for container. The selected batch of Adicovil passed all the IPQC and FDF tests in the procedure.

Authors

1-Ayesha Sabir
Undergraduate Students, Department of Pharmacy, Quaid I Azam University, Islamabad, Pakistan.

2-Syeda Komal Fatima
Undergraduate Students, Department of Pharmacy, Quaid I Azam University, Islamabad, Pakistan.

3-Asma Kaleem
Undergraduate Students, Department of Pharmacy, Quaid I Azam University, Islamabad, Pakistan.

4-Sidra Altaf
Undergraduate Students, Department of Pharmacy, Quaid I Azam University, Islamabad, Pakistan.

5-Imran Khan
Associate Professor, Riphah Institute of Pharmaceutical Sciences, Riphah International University, Lahore Campus, Lahore, Punjab, Pakistan.

Keywords

Parenteral, IPQC, stability tests, FDF, physical tests, chemical tests.

DOI Number

10.31703/gdddr.2017(II-I).05


Page Nos

44-55

Volume & Issue

II - I

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Published: Dec 2017

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