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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:
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% |
AIR-200 Standard Air Jet Sieving Machine is a more advanced sieving instrument compared to the AIMSIZER three-dimensional electromagnetic sieve shaker. It analyzes the size limits and particle size distribution of powders using the force of air jets rather than gravity, and it is also used for efficient separation and filtration of powders. The structure of the AIR-200 differs from that of the AIMSIZER three-dimensional electromagnetic sieve shaker, consisting of a sieve chamber, nozzle, standard test sieve, transparent cover, sieving control and analysis system, collector for sieved samples, vacuum cleaner, and more. Its features include short sieving time with high efficiency, not easy to clog the screen, effective elimination of agglomeration and static electricity, and a sieving lower limit down to 3 microns; automatic calculation of the percentage retained on the sieve, printing of sieving results, and other operations. It meets the requirements of ISO 4610, ASTM D5158, the European Pharmacopoeia (EP), and the United States Pharmacopoeia (USP).
Air jet sieving machine https://www.hmk-test.com



