Set up the comparison
Identify ibuprofen stereochemistry, particle-size grade and analytical method. Check the approved formulation’s raw material requirements first.
Measurements to record
Median particle size D50 (µm). Dry-dispersion laser diffraction. Confirm the distribution basis and dispersion conditions. Median particle size D50 (µm). Record separately from grade 25. A grade number is not a measured value. Record the sample ID and method revision for repeat testing.
Interpreting the results
Verify pharmacopoeial conformity and the required size window separately. Compare size distribution and loose bulk density on the same equipment using the same method.
What to record
- Stereochemical form
- Particle-size method
- Intended dosage form
- Quality standard
- Change review
Technical references
Products and processes
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