Male Sex Enhancement raw powder CAS 171596 29 5 Tadalafil

Product

Tadalafil

Batch No.

1601001

Date of Sampling

March 7,2016

Quantity

Sample

Date of Report

March 8,2016

Packing

-----

Test basis

EP 8

Items

Acceptance standard

Results of analysis

Appearance

White or almost white crystalline powder

White crystalline powder

Solubility

Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride

Conform to standard

Identification

The infrared absorption spectrum is concordant with the reference spectrum

Conform to standard

The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution

Conform to standard

Rotation

+78.0°~+84.0°

+80.29°

Impurities A, B and C

:

Impurity A≤0.15%

Non-detected

Non specific impurity≤0.1%

Non-detected

Loss on drying:

≤0.5%

0.075%

Residue on ignition

≤0.1%

0.05%

Heavy metals

≤0.002%

Conform to standard

(HPLC)Related substances

individual impurity≤0.1%

0.01%

Total unknown impurity≤0.3%

0.05%

Residual Solvents

methanol;≤0.3%

Non-detected

ethanol≤0.5%

0.025%

acetone≤0.5%

Non-detected