Tadanafil

Name

Tadalafil Powder

Appearence

White Crystalline Powder

Cas

171596-29-5

Assay

≥99.5%

Solubility

Insoluble In Water Or Alcohol, Soluble In Acetic Acid, Ethyl Ester

Melting Point

300-303°C

Loss On Drying

≤0.5%

Heavy Metal

≤10ppm

Specific Rotation

[a]20D=+70-72o(C=1.00,CHCl3)

Dosage

20-40mg

Onset Time

30 Minites

Grade

Pharmaceutical Grade

Package

1 Kg In An Aluminum Foil Bag, 25kg/drum.

Items

Specification

Results

Appearance

White Or Almost White Powder

White Powder

Solubility

Practically Insoluble In Water, Freely Soluble In Dimethyl Sulfoxide, Slightly Soluble In Methylene Chloride

conform

Identification

IR,UV

Positive

Special Optical Rotation (dried Substance)

78.0 To +84.0

81.0°

Impurities A, B And C

Impurity A: ≤0.15%

0.01%

Specified Impurities: ≤0.10%

conform

relative Substance

Unspecified Impurities: ≤0.10%

0.09%

Total Impurity: ≤0.3%

0.17%

Loss On Drying

≤0.5%

0.20%

Sulfated Ash

≤0.1%

0.06%

Assay (on Dried Basis)

97.5%~102%

99.57%