Chemical Description
--Polyvinylpolypyrrolidone (abbr. PVP-P)
CAS No. 9003-39-8
INCI Name Crosslinked PVP
Molecular and Structural Formula (C6H9NO)n
Characteristics
--A white to yellowish white, hygroscopic powder;
--Practically insoluble in water and other common solvents;
Specification Ph Eur ,USP/NF,BP,JP
No |
Tests
|
Specification
|
1
|
Identification, A B C D
|
Complies
|
2
|
Peroxides(as H2O2),ppm
|
≤400
|
3
|
Water-soluble substances,%
|
≤1.0
|
4
|
Impurity A (1-vinylpyrrolidone-2-one),ppm
|
≤10
|
5
|
Heavy metals, ppm
|
≤10
|
6
|
Loss on drying,%
|
≤5.0
|
7
|
Sulphated ash %
|
≤0.1
|
8
|
Assay, %
|
11.0-12.8
|
9
|
Average Particle size, Type A, um
|
100
|
10
|
Average Particle size, Type B, um
|
30
|
Application
--Disintegrant for tablets, granules and hard gelatin capsules;
--Stabilizer for oral and topical suspensions;
--Improvement of dissolution and bioavailability, Filtration aid;
Packaging and Storage
--Packed in 20 kg fiber or plastic drum, inner lined with PE bags;
--Stored in dry place at room temperature;