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Product Name:Polyvinylpyrrolidone
Chemical Description:Homopolymer of 1-Vinly-2-Pyrrolidone,Polyvinylpyrrolidone,PVP
INCI/CTFA:PVP
Pharmacopeia Name:Povidone(Povidonum)
CAS NO.:9003-39-8
Formula structure:
Product Properties: Povidone is a hygroscopic polymer ,supplied in white to creamy white powder or flakes,ranging from low to high viscosity & low to high molecular weight,which characterized by K Value.It’s easily soluble in water and many other organic solvents,with excellent hygroscopisty,film-forming,adhesive,chemical stability and toxicological safeness characters.
Applications:Povidone is one of the most important excipients in the worldwide for pharmaceutical industry,whatever for human health care products and animal health care products.Which used as:1)Binder for tables,capsule,2)Sugar coatings and films,3)Thickening agent,4)Solubility Improver for poorly soluble drugs,5)Bioavailability Enhancer for drug’s active ingredients,6)Pore-forming for membrane products.
Specifications:
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Product
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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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Appearance
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White or yellowish-white,hygroscopic powder or flakes
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Solubility
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Freely soluble in water,in ethano(96%) and in methanol,very slightly soluble in acetone.
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Appearance of Solution
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Clearly and not moren intensely coloured than reference solution B6,BY6 or R6
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Identifications
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Meet ID Tests
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pH Value(5% in aqueous solution)
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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(Expressed as K Value)
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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 as 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 as H2O2)
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400ppm 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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1ppm max.
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1ppm max.
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1ppm max.
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1ppm max.
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1ppm max.
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1ppm max.
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N-Vinylpyrrolidone(Impurity A)
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USP26
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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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Current 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(as 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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Water
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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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Sulphated Ash
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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 Content
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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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