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Finasteride

  • Product Name : Finasteride
  • Grade : IP / BP / USP
  • Therapeutic Category : Alopecia Agent
  • CAS No : 98319-26-7
  • COA : Available
  • MSDS : Available

Description

Treating urinary problems caused by an enlarged prostate gland (benign prostatic hyperplasia [BPH]). It is also used to lower the risk of needing surgery to treat BPH. It may be used with another medicine (doxazosin) to lower the risk of worsening BPH. It may also be used for other conditions as determined by your doctor.

 

Finasteride is a type of steroid reductase inhibitor. It works by reducing the amount of the hormone dihydrotestosterone (DHT) in the body. This makes the prostate gland smaller, which helps to relieve urinary problems.

 

Specification:

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 ofUSP 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.

 

 

Packaging details:

 

Packaging details:

1 kg/drum with double plastic bags inside; packed in a cardboard drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat.

Shelf Life:

5 years if sealed and store away from direct sun light.

Additional Information

The most common markets for this product include the following countries. Please inquire with us if your country or region is not listed:

Asia: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, etc.

Africa: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , etc.

North & South America: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, etc .

Europe: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, etc.

OCEANIA: Australia, New Zealand, Fiji, etc.

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