ITEMS

SPECIFICATION

METHOD

Appearance

Yellow to orange crystalline powder

Visual

Odor and Taste

Characteristic

Organoleptic

Identifications

Positive

IR

Potency

98.0-102%

HPLC

Melting Point

46-55°C

Melting point test Meter

Loss on Drying

≤0.2%

Oven @ 50°C

Residue on Ignition

≤0.1%

2g / 525°C / 5hrs

Solubility

Soluble in acetone; very slightly in ethanol, practically insoluble in water

Solubility Control

Lead(Pb)

≤10ppm

ICP-MS

Arsenic(As)

≤5ppm

ICP-MS

Cadmium(Cd)

≤3ppm

ICP-MS

Mercury(Hg)

≤10ppm

ICP-MS

Chromatographic Purity

Coenzymes Q7,Q8,Q9,Q11 and related impurities NMT 1.0%

Ubidecarenone(2Z)-Isomer and Related impurities NMT 1.0%

Total related impurities; NMT 1.5%

USP32

Solvent Residue

Complies

USP32

Total Plate Count

≤3000CFU/G

USP32

Yeast and moulds

≤300CFU/G

USP32

E.coli

Negative

USP32

Salmonella

Negative

USP32

Staphylococcus aureaus

Negative

USP32

P. Aeruginosa

Negative

USP32

Packing and Storage

Pack in aluminum-drums and two foil-bags inside. Net Weight: 25kgs/drums.

Store in a well-closed container away from moisture.

Shelf Life

2 years if sealed and store away from direct sun light at 0-25°C.

This product is made from Fermentation method, conform to Standard of USP32