Analytical Development & Quality Control

• Topic Related to Analytical Development & Quality Control

1. Alcohol Dose Dumping
2. Methods to Compare Dissolution Profiles
3. 21 CFR 11
4. Documentation Practice (GDP) & ALCOA++
5. Analytical Method Development
6. Peak Purity
7. Dissolution and Sinkers
8. Dissolution Apparatus
9. Analytical Instrument Category
10. GAMP Guideline
11. Good Laboratory Practices (GLP)
12. Disintegration Test
13. Calibration of Disintegration Test
14. Uniformity of Dosage Units (UOD)
15. High Performance Liquid Chromatography (HPLC)
16. Difference Between Stationary Phase and Mobile Phase
17. Difference Between C18 and C8 Column in HPLC Stationary Phase
18. What are theoretical plate numbers?
19. Difference Between Isocratic and Gradient Elution
20. Calibration of HPLC (High Performance Liquid Chromatography)
21. Theoretical plate numbers (N) and Determination of “N” in Chromatography
22. Gas Chromatography Columns
23. Basic of Gas Chromatography (GC) or Principle of GC
24. Gas Chromatography Detector (Type of GC Detectors)
25. Attenuated Total Reflectance (ATR)
26. Content Uniformity (CU)
27. Weight Variation (WV)
28. Loss on Drying (LOD)
29. What is Calibration, Verification, and Validation in pharmaceuticals?
30. Preparation and Standardization of 0.1 N Hydrochloric Acid (0.1 N HCl)
31. Preparation and Standardization of 0.1 N Sodium Hydroxide (0.1 NaOH)
32. Preparation and Standardization of 1 N Sulfuric Acid (H₂SO₄)
33. Shear Rate and Sink Conditions in Dissolution
34. Differential Scanning Calorimetry (DSC)
35. Operation, Use, Principle and Calibration of Fume Hood
36. Paper Chromatography
37. Thin Layer Chromatography
38. Difference Between Thin Layer and Paper Chromatography
39. Type of Glass container used in Pharmaceuticals
40. Type of HPLC Detectors
41. Difference between HPLC and UPLC
42. What are the Differences between GC and HPLC?
43. Data integrity
44. SOP on Operation and Calibration of UV Cabinet
45. SOP on Operation and Calibration Procedures of Vacuum Oven
46. Preparation of HPLC Mobile Phase
47. Color Code used in Pharmaceutical Industries for Gas Cylinder
48. SOP for Calibration of Micropipettes
49. SOP for Operation, Cleaning, and Calibration of pH Meter
50. SOP on Handling of HPLC and GC Columns
51. Calibration of AutoTirator (Metrohm)
52. Difference between UV and PDA Detector in HPLC
53. XRD Analysis

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For Acronyms and Abbreviations

Sources:

ICH: https://www.ich.org/

USFDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents

EMA: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines

MHRA: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

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