Test Item

Specification(U.S.P32)

Assay

Not less than 98% of C58H90O4  calculated on the anhydrous basis

Description

Yellow to orange crystalline powder

Identification

Color Reaction:a blue color appears

IR

Water

≤0.2%

Residue on ignition

≤0.1%

Particle size

Not less than 90% pass 80 mesh

Heavy metals

≤0.002%

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%

Residual solvents

Ethanol<1000ppm;Ethyl Acetate<100ppm;Hexane<50ppm

Standard plate count

≤1000cfu/g

Yeast&mold

≤50cfu/g

Coliforms

≤3cfu/g

Salmonella

Negative

E.coli.

Negative

S.aureus

Negative