Analytical Development & Quality Control

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  • 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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