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Khoom npe:Polyvinylpyrrolidone
Chemical Description:Homopolymer ntawm 1-Vinly-2-Pyrrolidone, Polyvinylpyrrolidone, PVP
INCI/CTFA:PVP
Lub npe Pharmacopeia:Povidone (povidonum)
CAS Nr .:9003-39-8
Khoom Properties:Povidone yog ib tug hygroscopic polymer, muab nyob rau hauv dawb mus creamy dawb hmoov los yog flakes, xws li los ntawm qis mus rau high viscosity & qis mus rau siab molecular hnyav, uas yog yus muaj los ntawm K nqi. film-forming, nplaum, tshuaj stability thiab toxicological kev nyab xeeb cim.
Daim ntawv thov:Povidone yog ib qho tseem ceeb tshaj plaws excipients nyob rau hauv lub ntiaj teb no rau kev lag luam tshuaj, txawm li cas los xij rau tib neeg noj qab haus huv cov khoom thiab cov khoom kho tsiaj.Uas siv raws li: 1) Binder rau cov ntxhuav, capsule, 2) qab zib coatings thiab films, 3) Thickening agent , 4) Solubility Improver rau cov tshuaj tsis zoo soluble, 5) Bioavailability Enhancer rau cov tshuaj nquag Cov khoom xyaw, 6) Pore-forming rau cov khoom membrane.
Specifications:
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Khoom
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Povidone K15
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Povidone K17
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Povidone K25
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Povidone K30
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Povidone K60
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Povidone K90
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Qhov tshwm sim
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Dawb los yog daj-dawb, hygroscopic hmoov los yog flakes
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Solubility
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Dawb soluble hauv dej, hauv ethano (96%) thiab hauv methanol, me ntsis soluble hauv acetone.
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Qhov tshwm sim ntawm kev daws teeb meem
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Kom meej meej thiab tsis muaj xim ntau dua li siv tshuaj B6, IB6los yog R6
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Cov cim
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Ua raws li Kev Xeem ID
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Tus nqi pH (5% hauv cov kua dej aqueous)
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3.0-5.0
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3.0-5.0
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3.0-5.0
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3.0-5.0
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4.0-7.0
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4.0-7.0
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Viscosity (Qhia raws li tus nqi K)
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12.75-17.25
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15.3-18.36
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22.5-27.0
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27.0-32.4
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54.0-64.8
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81.0-97.2
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Adehydes (Expressed li Acetaldehyde)
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500 ppm max.
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500 ppm max.
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500 ppm max.
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500 ppm max.
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500 ppm max.
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500 ppm max.
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Peroxides (Expressed li H2O2)
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400 ppm max.
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400 ppm max
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400 ppm max
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400 ppm max
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400 ppm max
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400 ppm max
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Formic Acid
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0.5% max.
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0.5% max.
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0.5% max.
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0.5% max.
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0.5% max.
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0.5% max.
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Hydrazine
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1 ppm max.
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1 ppm max.
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1 ppm max.
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1 ppm max.
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1 ppm max.
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1 ppm max.
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N-Vinylpyrrolidone (Impurity A)
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USP 26
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1000 ppm max.
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1000 ppm max.
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1000 ppm max.
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1000 ppm max.
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1000 ppm max.
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1000 ppm max.
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Tam sim no USP/EP/BP
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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2-Pyrrolidone (Impurity B)
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3. 0% max.
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3. 0% max.
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3. 0% max.
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3. 0% max.
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3. 0% max.
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3. 0% max.
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Heavy Metals (raws li Pb)
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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10 ppm max.
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Dej
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5.0% max.
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5.0% max.
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5.0% max.
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5.0% max.
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5.0% max.
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5.0% max.
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Sulfated tshauv
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0.1% max.
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0.1% max.
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0.1% max.
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0.1% max.
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0.1% max.
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0.1% max.
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Nitrogen ntsiab lus
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11.5-12.8%
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11.5-12.8%
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11.5-12.8%
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11.5-12.8%
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11.5-12.8%
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11.5-12.8%
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Cim npe nrov: Pharmaceutical qib pvp, Tuam Tshoj kws qib pvp manufacturers, hoobkas