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PVP-K HOMOPOLYMER SERIES

Chemical Description

--Polyvinylpyrrolidone (abbr. PVP)

■ CAS No. 9003-39-8

■ INCI Name  PVP

■ Molecular and Structural Formula (C6H9NO)n

 

■ Characteristics

--A white to yellowish white , hygroscopic powder;

--Freely soluble in water and a variety of organic solvents;

■ Specification Ph Eur ,USP/NF,BP,JP

No

Tests

K15

K17

K25

K30

K90

1

Identification, A B C D E

Complies

2

Appearance of solution

Clear, ≤B6,BY6 or R6

3

PH(in 5% solution)

3-5

3-5

3-5

3-5

4-7

4

Viscosity, as K-value

13-17

14.5-19.5

22.5-27

27-32.4

81-97

5

Aldehyde, ppm

≤500

≤500

≤500

≤500

≤500

6

Peroxides (as H2O2), ppm

≤400

≤400

≤400

≤400

≤400

7

Formic acid,%

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

8

Hydrazine, ppm

≤1

≤1

≤1

≤1

≤1

9

Impurity A (VP),ppm

≤10

≤10

≤10

≤10

≤10

10

Impurity B (2-pyrrolidone ),%

≤3.0

≤3.0

≤3.0

≤3.0

≤3.0

11

Heavy metals, ppm

≤10

≤10

≤10

≤10

≤10

12

Water, %

≤5.0

≤5.0

≤5.0

≤5.0

≤5.0

13

Sulphated ash,%

≤0.1

≤0.1

≤0.1

≤0.1

≤0.1

14

Assay, as Nitrogen content,%

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8

■ Application

--Binder for tablets, granules and hard gelatin capsules;

--Bioavailability enhencement, Film formation, Solubilization;

--Injection preparations, Stabilization of suspensions, Drug stabilization;

--Dietetic tablets in neutritional products;

■ Packaging and Storage

--Packed in 25, 50 kg fiber or plastic drum, inner lined with PE bags;

--Stored in dry place at room temperature;

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