Items

Acceptance criteria

Results

Character

Appearance: White or almost white powder.

Almost white powder

Solubility: Slightly soluble in water, freely

soluble in dilute acetic acid and in methanol,

slightly soluble in alcohol.

Complies

Identification

A.Specific optical rotation: –30.0º~-33.5º

(dried substance)

–33.3º

B.Infrared absorption spectrophotometry:

The IR spectrum is consistent with that

obtained with Levodropropizine CRS.

Complies

Tests

pH

9.2~10.2

9.4

Impurity B and related

substances

Impurity B: ≤ 0.5%

≤ 0.1%

Any other impurity: ≤ 0.1 %

≤ 0.1%

Total impurities: ≤ 0.6 %

≤ 0.1%

Impurity C

≤ 5 ppm

≤ 5ppm

Enantiomeric purity

Impurity A: ≤ 2 %

0.2 %

Loss on drying

≤ 1.0 %.

≤ 0.1%

Sulphated ash

≤ 0.2 %

≤ 0.1%

Assay

98.5%~ 101.0%(dried substance)

99.7%

Conclusion

The product meets the specification of EP7.0