pharm grade povidone PVP K17

TEST     ITEMS               

INDEX

TEST  VALUE

Appearance

White powder

White powder

Appearance of solution

Solution S is clear and not more intensely coloured than reference solution B₆ ,BY₆ or R₆

confirm

K VALUE

15.3～18.4

17.2

PH value (5% in water)

3.0～5.0

4.4

Solubility

Freely soluble in water,in methanol,and in alcohol,slightly soluble in acetone,practically insoluble in ether.

confirm

Identification

A.Consistent with the CRS

confirm

B.An orange-yellow precipitate is formed

confirm

C.A pale blue precipitate is formed

confirm

D.A deep red color is produced

confirm

E.The substance dissolves

confirm

Lead

≤2ppm

confirm

Residue on Ignition

≤0.1%

confirm

N-vinylpyrrolidone

≤0.001%

0.0002%

Moisture

≤5.0%

3.7%

Aldehyde

≤0.05%

0.005%

Heavy Metal

≤10ppm

confirm

Nitrogen

11.5%～12.8%

12.00%

Hydrazine

≤1.0ppm

＜1.0ppm

2-pyrrolidone

≤3.0%

0.1%

Peroxides (as H₂O₂)

      ≤400ppm

59ppm

Formic Acid

≤0.5%

0.001%

Residual Solvents (Isopropyl Alcohol)

≤0.5%

0.002%

TAMC

≤10³cfu/g

＜10cfu/g

TYMC

≤10²cfu/g

＜10cfu/g

E.Coli

Negative in 1g

Negative