CAS No.

9003-39-3

Molecular Formula

Molecular Weight

111.143

Molecular Structure

Storage

Keep in well-closed container, protected from light

Usage

Binder for tablets, granules and hard gelatin capsules

Bioavailability enhancement, film formation and solubilization

Injection preparations, stabilization of suspensions and drug stabilization

Dietetic tablets in nutritional products

Appearance

Light or yellowish-white,   hygroscopic powder

Identification A,B,C,D,E

Positive

Appearance of solution

Clear and NMT B₆, BY₆ or R₆

Solubility

Freely soluble in water, in ethanol(96%) and in   methanol, very slightly soluble in acetone

K-value

27.0-32.4

81.0-97.2

Water

≤5.0%

≤5.0%

Impurity A (1-vinylpyrrolidin-2-one)

≤10ppm

≤10ppm

Impurity B (2-pyrrolidone)

≤3.0%

≤3.0%

PH

3.0-5.0

4.0-7.0

Peroxides

≤400ppm

≤400ppm

Nitrogen Content

11.5-12.8%

11.5-12.8%

Heavy Metal

≤10ppm

≤10ppm

Sulphated Ash

≤0.1%

≤0.1%

Aldehydes

≤500ppm

≤500ppm

Hydrazine

≤1ppm

≤1ppm

Formic Acid

≤0.5%

≤0.5%

Total Aerobic Plate Count

≤100CFU/g

≤100CFU/g

Total Mold/Yeast Count

≤100CFU/g

≤100CFU/g

Standard

Latest USP, EP & JP