Quality Control Test For Suspensions

PERFECT SLIDE WITH ALL CORRECT AND USEFUL INFORMATION ABOUT THE QUALITY CONTROL TESTS FOR SUSPENSIONS....

1. Presented by:- BHANU BISWAS m.pharm (quality assurance) 2018-19 Maharishi markandeswar (Deemed to be university) March 27, 2018 1

2. Quality control  (QC) is a procedure or set of procedures that ensures that the manufactured product adheres to a defined set of quality criteria or meets the requirements of the customer. Suspension is defined as a biphasic liquid dosage form in which a solid is dispersed in liquid. March 27, 2018 2

3. PURPOSE To ensure any kind of human errors. To ensure the quality of final product. To ensure continuous monitoring of process variables which are going to affect the quality of product. March 27, 2018 3

4. QUALITY CONTROL TESTS Appearance Photo microscopic examination Color , odour & taste pH value Pourability Viscosity Redispersibility Particle Size March 27, 2018 4

5. APPEARANCE It must appear uniform and elegant. Particles of suspensions should be well distributed. No hard cake formation of particles. The suspension is poured in a transparent glass container and it should be checked if there is any coagulated material adhering to the inside wall of the container. March 27, 2018 5

6. PHOTO MICROSCOPIC EXAMINATION The suspension is examined for particle size distribution and crystal habit under microscope with camera. It is mainly used to differentiate between flocculated and deflocculated particles. March 27, 2018 6

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9. COLOUR, ODOUR & TASTE This technique is mostly done for orally administrated suspensions. Variation in colour indicates poor distribution. Varialtion in taste is generally due to particle size and crystal habit. Change in either colour, odour or taste indicates chemical instability. March 27, 2018 9

10. pH Value pH of the phases of suspension also contribute to the stability and characteristics of formulations. So pH of the different vehicles, phases of suspension before mixing and after mixing are monitored and recorded time to time to ensure optimum pH environment. Different methods are: a)Dip a piece of pH paper into the sample. b)pH meter March 27, 2018 10

11. POURABILITY This test is carried out to ensure that the final preparation is pourable and will not cause any problem during filling and during handling by the patient. March 27, 2018 11

12. VISCOCITY Stability of a suspension is dependant on the sedimentation rate of dispersed phase which is dependant on the viscosity of the dispersion medium. So this test is carried out to ensure optimum viscosity of the medium so a stable, redispersible suspension can be formed. March 27, 2018 12

13. The calculated values are compared with standard values and if any difference is found necessary corrective action is taken to get optimized viscosity. The viscosity can be measured by:- a)cup and bob viscometer b)cone and plate viscometer March 27, 2018 13

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16. REDISPERSIBILITY If the particles settle they should be easily redispersible by a moderate amount of shaking March 27, 2018 16

17. PARTICLE SIZE Optimum size of drug particle in the dispersed phase plays a vital role in stability of final suspension. So this test is carried out by microscopically analysis and find out particle size range of drug then it is compared with optimum particle size required. If any difference is found, strict monitoring of micronization step is ensured. March 27, 2018 17

18. Particle size can be measured by:- a)optical microscopic method b)sedimentation method c)conductivity method March 27, 2018 18

19. CONCLUSION These all steps are carried out to ensure stable, safe and high quality of suspension products. March 27, 2018 19

20. THANK YOU... March 27, 2018 20