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.
Keywords : Parenteral, IPQC, stability tests, FDF, physical tests, chemical tests.
Authored by :
(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.
Global Drug Design and Development Review (GDDDR) was introduced by Humanity Only (HO) through the research project sponsored and guided by Humanity Research Council (HRC) — a sub-body of Humanity Development Society (HDS). GDDDR intends to promote qualitative and quantitative researches and findings with the help of newly emerging tools and patterns utilized in experiments, observations, interviews, analysis and surveys by encircling all major segments of Pharmaceutical Studies and its academic and research disciplines. GDDDR is a double-blind peer-reviewed research journal which encompasses major disciplines of Pharmaceutical Studies.
