HPMC Capsules specification
Nov yog ib lub rooj qhia txog qee qhov kev qhia tshwj xeeb rau hypromellose (HPMC) capsules:
| Specification | Tus nqi |
|---|---|
| Hom | Hypromellose (HPMC) ntsiav tshuaj |
| Qhov ntau thiab tsawg | #00 – #5 |
| Xim xaiv | Ntshiab, dawb, xim |
| Qhov nruab nrab sau hnyav muaj peev xwm | Nws txawv los ntawm cov tshuaj ntsiav loj thiab cov chaw tsim khoom |
| Dissolution tus nqi | Nws txawv ntawm qhov loj me, hypromellose concentration, thiab formulation |
| Cov dej noo | ≤ 6.0% |
| Poob rau ziab | ≤ 5.0% |
| Cov hlau hnyav | ≤ 20 ppm |
| Microbial txwv | ≤ 1,000 cfu / g rau tag nrho aerobic microbial suav; ≤ 100 cfu / g rau tag nrho cov poov xab ua ke thiab pwm |
| Cov kuab tshuaj residual | Ua raws li USP 467 |
| Particle loj faib | 90% ntawm cov khoom yog nyob rau hauv 200 - 600 µm |
| Txee lub neej | 3-5 xyoos thaum khaws cia rau hauv qhov chaw txias, qhuav |
Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias cov kev qhia tshwj xeeb no yuav txawv nyob ntawm cov chaw tsim khoom tshwj xeeb thiab kev tsim cov tshuaj hypromellose capsules. Nws yog ib txwm pom zoo kom sab laj cov khoom specifications muab los ntawm cov chaw tsim khoom rau cov khoom tshwj xeeb uas koj siv.
Post lub sij hawm: Mar-04-2023