Medical Liaison Officer
Medical Liaison Officer Club
Quality Requirements and Inspection of Powdered Medicine
Particle Size, Moisture Content, and Uniformity Requirements and Inspection
Quality Requirements of Powdered Medicine
① Particle Size Requirements
Internal Powder: Fine Powder
Pediatric and External Use Powders: Very Fine Powder
External Powders for Burns or Severe Wounds: The weight of the powder passing through a No. 6 sieve must not be less than 95%;
Ophthalmic Powders: Extremely Fine Powder
② Moisture Content ≤ 9.0%
③ Uniformity Requirements
For single-dose packaged powders, the weight of the contents in each bag (bottle) must not exceed the limit by more than 2 bags (bottles), and no more than 1 bag (bottle) may exceed the limit by 1 time.
④ Sterility: Ophthalmic powders and external powders for burns or severe wounds
Quality Inspection of Powdered Medicine
1. Appearance Uniformity
2. Moisture
3. Weight Variation
4. Weight (for multi-dose packaged powders)
5. Sterility
6. Microbial Limits
