Pharmaceutical 99%Finasteride Powder

TEST

SPECIFICATIONS

RESULTS

Appearance

White Or Almost White Crystalline Powder. Melts At About 257°C

Complies

Assay (HPLC, Based On Drying)

98.5% ~ 101.0% Calculated On

anhydrous Basis

99.55%

Identification

Infrared

Absorption

Retention

time

Corresponds To Spectrum Of

USP Finasteride RS

Retention Time Of Major Peak

of Assay Preparation

corresponds To USP Finasteride

RS Preparation

Corresponds To Spectrum Of USP Finasteride RS

Retention Time Of Major

peak Of Assay Preparation

corresponds To USP

Finasteride RS Preparation

Specific Rotation

-56.0°~ -60.0°

-57.5°

Melting Point

Melts At About 257°

complies

Solubility

Free Soluble In Chloroform And

in Alcohol,very Slightly Soluble

in Water

Complies

Water (Method I)

≤0.3%

0.16%

Residue On Ignition

≤0.1%

0.07%

Heavy Metals (Method II)

≤10 Ppm

Complies

Chromatographic Purity

Single Largest Impurity: ≤0.5%

0.09%

Total Impurities: ≤1.0%

0.28%

Particle Size

100% < 30 Micron

Complies

90% < 25 Micron

Complies

Conclusion

The Test Product Complies With The Requirements Of USP32.