Pharmaceutical Grade PVP - Shanghai WellTone Material Technology Co., Ltd

Structural formula

Product Properties

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

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

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.
N-Vinylpyrrolidone(Impurity A)	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%