Color

Yellow-orange

Appearance

 Powder

Odour

Characteristic

Identification

IR: Sample spectrum consistent with the spectrum for USP Reference Standard                                      Color reaction: blue color appears

Assay (anhydrous basis)

98.0-101%

Sieve analysis

100 % through 80 mesh   90% pass 100 mesh

Melting point

≤48℃-52℃

Tapped density

0.40g/mL-0.60g/m

Solubility

Soluble in ether, trichloromethane and acetone, very slightly soluble in dehydrated alcohol, partically insoluble in water

Residue on ignition

≤0.10%

Water (KF）

≤0.20%

Heavy Metals

≤10.0 mg/kg

Arsenic(as As)

≤1 mg/kg

Lead(as Pb)

≤0.5mg/kg

Mercury（Hg）

≤0.1 mg/kg

Cadmium

≤0.5 mg/kg

Solvents Residue

Methanol<3000ppm

n-Hexane<290ppm

Ethanol<5000ppm

Isopropyl ether≤300ppm

Coenzymes Q7,Q8,Q9,Q11

and related impurities

≤1.0%

Ubidecarenone (2Z)-isomer and related impurities

≤0.5%

total impurities

Total 1& 2≤1.5%

Total Plate Count

≤1000 cfu/g

Yeast &Mold

≤50 cfu/g

E.Coli.

Absent/10g

Salmonella

Absent/25g

Bile-tolerant gram negative

bacteria

≤10 MPN/g

Staphylococcus aureus

Absent/25g