ITEM

SPECIFICATION

Appearance

Yellow or orange, crystalline powder

Identification

A: IR

B: Color Reaction

C: HPLC

Corresponds qualitatively to the reference

A blue color appears

Corresponds qualitatively to the reference

Melting Point

48.0°C-52.0°C

Water

≤0.2%

Residue on Ignition

≤0.1%

Particle Size

Not less than 90% pass 80 mesh

Heavy Metal

≤10ppm

Arsenic

≤1ppm

Lead

≤1ppm

Mercury

≤0.1ppm

Cadmium

≤1ppm

Residue Solvents

Ethanol≤1000ppm

Ethyl Acetate≤100ppm

N-hexane≤1ppm

Chromatographic purity

Test 1: Sum of all impurities: ≤1.0%

Test 2: Sum of all impurities: ≤1.0%

Test 1 & Test 2: Sum of all impurities: ≤1.5%

Related Substances

Single impurity: not more than 0.5%

Sum of all impurities: not more than 1.0%

Impurity F

≤0.5%

Plate Count

≤1000cfu/g

Yeast & Mold

≤50cfu/g

Coliforms

≤3MPN/g

E. Coli

Negative/10g

Salmonella

Negative/25g

S.aureus

Negative/25g

Content (%)

Not less than 98.0% and not more than 101.0% of C59H90O4 calculated on the anhydrous basis