Dexamethasone

Pharmaceutical Quality Management of Dexamethasone tablets BP
Dexamethasone tablets USP
DEXAMETHSONE OPTHALMIC SUSPENSION BP
DEXAMETHSONE OPTHALMIC SUSPENSION USP
Dexamethasone is a synthetic (man-made) corticosteroid.
Corticosteroids are naturally-occurring chemicals produced by the adrenal glands located above the kidneys.

1. Tablets B P

2. DEXAMETHASONE

3. DEXAMETHASONE TABLETS

4. IDENTIFICATION

5. Tablets containing less than 2mg or less than 2% w/w of dexamethasone comply with the requirement Carry out the method for liquid chromatography UNIFORMITY OF CONTENT

6. (2) CHROMATOGRAPHIC CONDITIONS: Stainless steel column Isocratic elution Flow rate of 1.4ml/min Ambient column temperature Detection wavelength of 238nm Inject 20µL of each solution 0.0025% w/v of dexamethasone in methanol (50%)

7. Tablets containing less than 2mg or less than 2% w/w of dexamethasone ASSAY Use the average of the 10 individual results obtained in the test for uniformity of content

8. Tablets containing 2mg or more than 2% w/w of Dexamethasone: (1) ASSAY

9. (2) STORAGE: Dexamethasone tablets should be protected from light 0.0125% w/v of dexamethasone BPCRS in methanol 50%

10. Tablets USP

11. Introduction

12. Dissolution

13. Procedure

14. DIFFERENCE B/W CONTENT UNIFORMITY & ASSAY

15. PROCEDURE FOR CONTENT UNIFORMITY

16. ASSAY

17. Sterile Ophthalmic Suspension BP

18. Introduction:

19. IDENTIFICATION

20. TESTS:

21. ASSAY

22. CHROMATOGRAPHIC CONDITIONS:

23. IMPURITIES

24. Sterile Ophthalmic Suspension USP

25. SABIHA GUL 131027

26. INTRODUCTION

27. PACKAGING AND STORAGE

28. IDENTIFICATION :

29. STERILITY Should be meet the requirement

30. pH

31. ASSAY

32. PROCEDURE Separately inject equal volumes of the standard preparation and the assay preparation into the chromatograph, record the chromatographs and measure the responses for the major peaks.Calculate the quantity in mg of Dexamethasone in each mL of the opthalmic suspension using formula: 25(C/V)( ru / rs )

33. Reporting

34. TEST RANGE/ LIMIT RESULT COMMENTS/ REMARKS Identification IR spectrum Concordant with RS 089 Concordant. Identified. Uniformity of content L1 (maximum allowed acceptance value) is 15 A.V= 5.6 Accepted. Assay 95-105% 97% Accepted. Dexamethasone tablets BP

35. TEST RANGE/ LIMIT RESULT COMMENTS/ REMARKS Identification R F value corresponds to standard. Corresponded. Identified. Dissolution Not less than 70% of labeled amount of C 22 H 29 FO 5 is dissolved in 45minutes. 85% C 22 H 29 FO 5 is dissolved. Passed. Uniformity of dosage units L1 (maximum allowed acceptance value) is 15 A.V = 5.6 Accepted. Assay 90-110 % 97% Accepted. Dexamethasone tablets USP

36. DEXAMETHSONE OPTHALMIC SUSPENSION BP TEST RANGE/ LIMIT RESULT COMMENTS/ REMARKS Identification IR spectrum Concordant with RS 089 Concordant. Identified. Particle size Not more than 20 particles >25µm Not more than 2particles >50µm No particle >90µm 19paricles are >25µm 1 particle is >50µm No particle is >90µm Accepted. Acidity pH 5.0-6.0 pH is 5.6 Accepted. Assay 95-105% 97% Accepted.

37. DEXAMETHSONE OPTHALMIC SUSPENSION USP TEST RANGE/ LIMIT RESULT COMMENTS/ REMARKS Identification R F value corresponds to standard. Corresponded. Identified. Sterility Should be no evidence of microbial growth. The product complies with the test for sterility. Passed the sterility test. pH 5.0-6.0 pH is 5.6 Accepted. Assay 90-110 % 97% Accepted.

38. Any Question? The End 