Standards for Registration of Imported Drugs Standard Number: JX20000294 Microcrystalline Cellulose
Standards for Registration of Imported Drugs Standard Number: JX20000294 Microcrystalline Cellulose
[Inspection] Particle Size: Take 10.0 g of this product, place it on a AIR-200 air jet sieve, set the timer to 3 minutes (5 minutes for a 32 μm sieve), and adjust the pressure to 1.5-2.0 Pa·s (for 40 μm and 32 μm sieves, adjust the pressure to 2.5-4.0 Pa·s). Start sieving, gently tap the top and sides of the sieve with a plastic hammer during the process to prevent material from accumulating on the sieve. After sieving, weigh the test sample remaining on the sieve and calculate the percentage of residue. The requirements for different specifications of the test sample are as follows:
AIR-200 Air Jet Sieving Machine
Sample Specifications Particle Size Residual Sample Percentage
| Sample Specifications | Particle Size | Residual Sample Percentage |
| TYPE 101 | >250um
>75um >32um |
Do not exceed 1%
Do not exceed 30% Should be greater than 50% |
| TYPE 102 | >250um
>75um >32um |
Do not exceed 8%
Should be greater than 45% Should be greater than 70% |
| TYPE 12 | >400um
>160um >50um |
Do not exceed 1%
Do not exceed 50% Should be greater than 70% |