Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Evaluation of Ointments & Creams          Dr. Khalid Hussain:khussain.pharmacy@pu.edu.pk
1- Physical appearance   The main characteristics need to be checked    are    –   Cracking of creams (separation of oil ...
2-Particle size determination   Dilute a suitable qty of preparation with equal    volume of glycerol or liquid paraffin,...
3-Weight variation test Applies to those products in which  labeled net weight is not more than 150g Select 10 filled co...
   Dry and again weigh each empty container    together with its corresponding part, take    difference as weight of cont...
   And not less than 95% of the labeled amount    (60-150g)   If this requirement is not met repeat this    procedures t...
   Contents of not more than 1 of the 30 units    should be less than 90% of the stated    amount (for ≤ 60g)   And not ...
4-Solubility test   The preparation should be soluble in 9 parts    of water and 1.7 parts of hot water    The preparati...
5-Viscosity determination   Viscosity is determined using a method    specified in official monograph
6-Active ingredients   Assay of active ingredients should be    performed according to monograph   Percentage contents s...
7-Microbial contamination   Microorganisms can grow, if no preservative    is added, or even if added, its efficiency is ...
   Antimicrobial assay should be performed    according to official monograph, usually    –   Direct inoculation method  ...
8-Metal Particle in OphthalmicOintments   Extrude completely the contents of 10 containers    separately into flat bottom...
   Count the metal particles of 50µm or larger   The requirement is met if total number of such particles    in all 10 t...
Upcoming SlideShare
Loading in …5
×

Qc tests of ointments

23,634 views

Published on

Published in: Technology, Business

Qc tests of ointments

  1. 1. Evaluation of Ointments & Creams Dr. Khalid Hussain:khussain.pharmacy@pu.edu.pk
  2. 2. 1- Physical appearance The main characteristics need to be checked are – Cracking of creams (separation of oil and water) – Development of granular and lumpy appearance – Marked change in viscosity – Crystal growth – Microbial contamination
  3. 3. 2-Particle size determination Dilute a suitable qty of preparation with equal volume of glycerol or liquid paraffin, as specified Mount on a glass slide and examine under light microscope Count the number of particles with daimeter above or below than that specified in monograph Compare the percentage with official limits
  4. 4. 3-Weight variation test Applies to those products in which labeled net weight is not more than 150g Select 10 filled containers, remove the label, clean and weigh individually Remove the contents by cutting the containers and wash with suitable solvent
  5. 5.  Dry and again weigh each empty container together with its corresponding part, take difference as weight of contents. The average net weight of contents of 10 containers should not be less than the labeled amount The net weight of contents of any single container should not be less than 90% of the labeled amount (for ≤ 60g)
  6. 6.  And not less than 95% of the labeled amount (60-150g) If this requirement is not met repeat this procedures taking additional 20 containers The average net weight of contents of 30 containers should not be less than labeled amount
  7. 7.  Contents of not more than 1 of the 30 units should be less than 90% of the stated amount (for ≤ 60g) And not less than 95% of the labeled amount (60-150g)
  8. 8. 4-Solubility test The preparation should be soluble in 9 parts of water and 1.7 parts of hot water The preparation should be miscible with alcohol, ether and chloroform
  9. 9. 5-Viscosity determination Viscosity is determined using a method specified in official monograph
  10. 10. 6-Active ingredients Assay of active ingredients should be performed according to monograph Percentage contents should be within the official limits
  11. 11. 7-Microbial contamination Microorganisms can grow, if no preservative is added, or even if added, its efficiency is reduced due to interaction with other ingredients Microorganisms may get into the preparation during handling and storage Therefore, aseptic techniques of handling are needed
  12. 12.  Antimicrobial assay should be performed according to official monograph, usually – Direct inoculation method – Membrane filtration method
  13. 13. 8-Metal Particle in OphthalmicOintments Extrude completely the contents of 10 containers separately into flat bottom Petri dishes Cover, heat at 85oC for 2 h and cool slowly to solidify Remove the cover and invert on the stage of microscope adjusted to 30 times magnification and equipped with eye-piece micrometer disk calibrated for this magnification. Additional illuminator may also used Examine the entire bottom of Petri dish for metal particles.
  14. 14.  Count the metal particles of 50µm or larger The requirement is met if total number of such particles in all 10 tubes does not exceed 50 Not more than 1 tube contains more than 8 such particles If not, repeat with 20 more tubes The requirement is met if total number of such particles in 30 tubes is not more than 150 And not more than 3 containers allowed to contain more than 8 particles

×