Details:
Pharmacopeia Name:Povidone(Povidonum)
CAS NO.:9003-39-8
Formula structure:
Product Properties: Povidone is a hygroscopic polymer ,supplied in white or 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 excipient in the worldwide for pharmaceutical industry,whatever for human health care products and animal health care products.It’s more and more 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:
Product
|
Povidone K15
|
Povidone K17
|
Povidone K25
|
Povidone K30
|
Povidone K60
|
Povidone K90
|
Appearance
|
White or yellowish-white,hygroscopic powder or flakes
|
Solubility
|
Freely soluble in water,in ethano(96%) and in methanol,very slightly soluble in acetone.
|
Appearance of Solution
|
Clearly and not moren intensely coloured than reference solution B6,BY6 or R6
|
Identifications
|
Meet ID Tests
|
pH Value(5% in aqueous solution)
|
3.0-5.0
|
3.0-5.0
|
3.0-5.0
|
3.0-5.0
|
4.0-7.0
|
4.0-7.0
|
Viscosity(Expressed as K Value)
|
12.75-17.25
|
15.3-18.36
|
22.5-27.0
|
27.0-32.4
|
54.0-64.8
|
81.0-97.2
|
Adehydes(Expressed as Acetaldehyde)
|
500 ppm max.
|
500 ppm max. |
500 ppm max. |
500 ppm max. |
500 ppm max. |
500 ppm max. |
Peroxides(Expressed as H2O2)
|
400ppm max.
|
400 ppm max |
400 ppm max |
400 ppm max |
400 ppm max |
400 ppm max |
Formic Acid
|
0.5% max.
|
0.5% max. |
0.5% max. |
0.5% max. |
0.5% max. |
0.5% max. |
Hydrazine
|
1ppm max.
|
1ppm max. |
1ppm max. |
1ppm max. |
1ppm max. |
1ppm max. |
N-Vinylpyrrolidone(Impurity A)
|
USP26
|
1000 ppm max.
|
1000 ppm max. |
1000 ppm max. |
1000 ppm max. |
1000 ppm max. |
1000 ppm max. |
Current USP/EP/BP
|
10 ppm max.
|
10 ppm max. |
10 ppm max. |
10 ppm max. |
10 ppm max. |
10 ppm max. |
2-Pyrrolidone(Impurity B)
|
3.0% max.
|
3.0% max. |
3.0% max. |
3.0% max. |
3.0% max. |
3.0% max. |
Heavy Metals(as Pb)
|
10 ppm max.
|
10 ppm max. |
10 ppm max. |
10 ppm max. |
10 ppm max. |
10 ppm max. |
Water
|
5.0% max.
|
5.0% max.
|
5.0% max.
|
5.0% max.
|
5.0% max.
|
5.0% max.
|
Sulphated Ash
|
0.1% max.
|
0.1% max.
|
0.1% max.
|
0.1% max.
|
0.1% max.
|
0.1% max.
|
Nitrogen Content
|
11.5-12.8%
|
11.5-12.8%
|
11.5-12.8%
|
11.5-12.8%
|
11.5-12.8%
|
11.5-12.8%
|
|
|
|
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