Quality Control of Parenterals

Topics: Integers, 1, Prime number Pages: 35 (8883 words) Published: August 27, 2013
2012
Quality Control of Parenteral

DEPARTMENT OF PHARMACY

Page Number 1

QUALITY CONTROL OF PARENTERAL SUBJECT:

PHARMACEUTICAL QUALITY CONTROL
ASSIGNMENT TOPIC:

QUALITY CONTROL OF PARENTRAL
SUBMITTED TO:

 SIR SHAMS-UL-HASSAN.
SUBMITTED BY:              MUHAMMAD ARSLAN ABDULLAH MUHAMMAD REHAN AZMAT JAWAD AHMAD KHAN MUHAMMAD USMAN SAADULLAH HAFIZ ISRAR AHMAD MUHAMMAD ASIF FAHIM RASHID INTASAR HUSSAIN MUNAWAR ALI MUHAMMAD NADEEM HASSAN RANA KASHIF MUGHAL (BPD 01093179). (BPD 01093168). (BPD 01093082). (BPD 01093081). (BPD 01093080). (BPD 01093059). (BPD 01093150). (BPD 01093242). (BPD 01093062). (BPD 01093186). (BPD 01093252). (BPD 01093241). (BPD 01093147).

(Pharm-D, 7th Semester, Section-A)

Department Of Pharmacy The University Of Lahore
7th - A | Survivors| The University of Lahore

Page Number 2

QUALITY CONTROL OF PARENTERAL TABLE OF CONTENTS

INTRODUCTION _________________________________________________________ 4 1) PYROGEN TESTING ___________________________________________________ 4 Introduction ______________________________________________________________________ 4 A.         

Rabbit Pyrogen Test (RPT) _______________________________________________________ 5 Introduction _________________________________________________________________________ Selection of animals ___________________________________________________________________ Animal quarters ______________________________________________________________________ Retaining boxes ______________________________________________________________________ Materials ____________________________________________________________________________ Thermometer ________________________________________________________________________ Preliminary test ______________________________________________________________________ Main test ____________________________________________________________________________ Interpretation ________________________________________________________________________ 5 5 6 6 6 7 7 7 8

B.
         

Limulus Amebocyte Lysate (LAL) Test ______________________________________________ 9 Introduction _________________________________________________________________________ 9 History ______________________________________________________________________________ 9 Purpose _____________________________________________________________________________ 9 Reagents Used ______________________________________________________________________ 10 Preparation Of Lal Reagent/Lysate ______________________________________________________ 10 Mechanism _________________________________________________________________________ 11 Specifications _______________________________________________________________________ 12 Techniques _________________________________________________________________________ 12 Methods ___________________________________________________________________________ 12 Procedure __________________________________________________________________________ 13

C.
      

Monocyte Activation Test MAT __________________________________________________ 17 History _____________________________________________________________________________ 17 Introduction ________________________________________________________________________ 18 General Procedure ___________________________________________________________________ 18 Apparatus __________________________________________________________________________ 19 Procedure Of MAT Test _______________________________________________________________ 19 Conclusion __________________________________________________________________________ 21 Comparison Between LAL & MAT _______________________________________________________ 21

7th - A | Survivors| The University of Lahore

Page Number 3

QUALITY CONTROL OF PARENTERAL 2) STERILITY TESTING___________________________________________________ 22    Introduction...

References:  Parenteral Quality Control[Sterility, Pyrogen,
Particulate and Package Integrity Testing], Third Edition, Revised and Expanded By Michael J. Akers and Daniel S. Larrimore.
 Appendix XIV C, XIV H, XVI, XVI A, XVI B of
British Pharmacopoeia 2011.
 Particle
Size Distribution Estimation/ Physical Tests, United States Pharmacopoeia 2011 .
7th - A | Survivors| The University of Lahore
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