China (Mainland)
Quick Details
- CAS No.: 9003-39-8
- Type: Auxiliaries and Other Medicinal Chemicals
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 |
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|
2 |
Appearance of solution |
Clear, ≤B6,BY6 or R6 |
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|
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;