Items

Specification

Results

Appearance

A light yellow-brownish red liquid

Complies

Odor

Mild characteristic

Complies

Acidity

≤1ml

0.21ml

Specific rotation

≥+20°

+25.86°

Heavy metals(as Pb)

≤10ppm

Complies

Content of total tocopherols

90.35%

Remarks: d-α:12.48%; d-β+γ:50.16%; d-δ:22.71%

Microbiogical test

Total Plate Count

≤1000CFU/gm

Complies

Yeast&Moulds

≤100CFU/gm

Complies

Coliform

Negative

Negative

Conclusion:  All the results conform to the USP30/FCCV.

ITEM

SPECIFICATIONS

RESULTS

Appearance

Slightly yellow, clear, viscous oil

Qualified

Assay by G.C

98.0—102.0%

98.8%

Identity

Corresponds

Qualified

Infrared spectrum

Meets EP requirement

Qualified

Option rotation

-0.01°~ +0.01°

Qualified

Density(20°C)

0.952—0.966g/ml

0.955g/ml

Refractive index(20°C)

1.494—1.498

1.496

Related substances

Impurities A, C: for each impurity ≤ 0.5%

Impurity B ≤ 1.5%

Sum of impurity D+E ≤ 1.0%

Any other impurities: Meet EP requirements

Total impurities: ≤ 2.5%

Qualified

Absorbance in ethanol:

At about 284nm (max)

At about 254nm (min)

42.0—45.0

7.5—9.0

44.0

8.8

Acidity

Max.1.0ml of 0.1 N NaOH

0.04 ml

Sulphated ashes

≤0.1%

0.03%

Heavy metals

≤10ppm

<5ppm

Lead

≤2ppm

0.04ppm

Arsenic

≤3ppm

<1ppm

Free tocopheryl

≤1.0%

0.35%

Organic volatile impurities

Meets USP requirements

Qualified

Conclusion: The product complies with USP/EP standard