Crospovidone
Pharmaceutical ExcipientCrospovidone yog ib tug crosslinked PVP, insoluble PVP, nws yog hygroscopic, insoluble nyob rau hauv dej thiab tag nrho lwm cov kuab tshuaj, tab sis nws swells sai sai nyob rau hauv aqueous solutbition tsis muaj gel los ntawm nws; cais raws liCrospovidone Hom Athiab hom B raws li qhov sib txawv particle loj.
Tseem ceeb Technical Parameters:
Khoom | Crospovidone Hom A | CrospovidoneHom B |
Qhov tshwm sim | Dawb los yog daj-dawb hmoov los yog flakes | |
Cov cim | A. Infrared Absorption | |
B. Tsis muaj xim xiav tsim. | ||
CA Suspension yog tsim thiab tsis muaj kev daws teeb meem meej hauv 15 min. | ||
D. Feem ntau ntawm cov khoom yog nyob rau hauv thaj tsam 50 ~ 300 μm yog hom A, feem ntau ntawm cov khoom yog nyob rau hauv thaj tsam 5 ~ 50 μm | ||
Solubility | Xyaum insoluble hauv dej, hauv cawv thiab hauv methylene chloride | |
Cov dej-soluble | 1.0% max | 1.0% max |
pH (1% hauv dej) | 5.0-8.0 Nws | 5.0-8.0 Nws |
Poob rau ziab | 5.0% max. | 5.0% max. |
Sulfated tshauv | 0.1% max. | 0.1% max. |
Cov ntsiab lus nitrogen | 11.0-12.8% | 11.0-12.8% |
impurity A | 10 ppm max. | 10 ppm max. |
Peroxide (Raws li H2O2) | 400 ppm max. | 1000 ppm max. |
Hnyav Hlau | 10 ppm max. | 10 ppm max. |
Daim ntawv thov:
Crospovidone yog dav siv raws li 1) Disintergrating tus neeg saib xyuas, 2) Stabilizer rau ncua kev kawm ntawv, 3) Moisture Absorbent, 4) complextant ntawm Polyphenols thiab Tannin rau cov extract formulations.
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Qib zaub movPVPPyog crosslinked PVP, insoluble, nws yog hygroscopic, insoluble nyob rau hauv dej thiab tag nrho lwm cov kuab tshuaj, tab sis nws swells sai sai nyob rau hauv aqueous solutbition tsis muaj gel los ntawm.
Tseem ceeb Technical Parameters:
Khoom | PVPP (Ib Txoj Kev) | PVPP (Regenerate) |
Qhov tshwm sim | Dawb mus rau dawb, hygroscopic, dawb-ntws hmoov | |
Solubility | Insoluble hauv dej thiab lwm yam kuab tshuaj. | |
Cov ntxhiab tsw ntawm qhov raug ncua | Faint, Hom | |
Nitrogen | 11.0-12.8% | 11.0-12.8% |
Cov hlau hnyav (As Pb) | 10 ppm max. | 10 ppm max. |
Coj | 2 ppm max. | 2 ppm max. |
Arsenic | 2 ppm max. | 2 ppm max. |
pH (1% hauv dej Suspension) | 5.0-8.0 Nws | 5.0-8.0 Nws |
Sulfated tshauv | 0.4% max. | 0.4% max. |
Cov dej soluble | 0.5% max. | 0.5% max. |
Solubility hauv Acetic Acid / Ethnol | 1.0% max. | 1.0% max. |
Peroxides | 400 ppm max. | 400 ppm max. |
N, N-Divinylimidazolidione | 2 ppm max. | 2 ppm max. |
N-Vinylpyrrolidone | 10 ppm max. | 10 ppm max. |
Dej | 5.0% max. | 5.0% max. |
Paticle Loj | / | / |
Daim ntawv thov:
Ua tsaug rau nws cov khoom insoluble hauv dej thiab lwm yam kuab tshuaj, PVPP yog dav ua raws li stabilizers & clarifier rau Npias / Wine thiab lwm yam dej haus cov khoom, nws muaj peev xwm romove polyphenols thiab tannins tshuaj thaum lub sij hawm lub npias / Wine / dej haus ua.
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