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Tamsulosin HCl

  • Product Name : Tamsulosin HCl
  • Grade : IP / BP / USP
  • Therapeutic Category : Nonsteroidal antiestrogen
  • CAS No : 106463-17-6
  • COA : Available
  • MSDS : Available

Description

Tamsulosin HCL or Tamsulosin Hydrochloride is primarily used for benign prostatic hyperplasia, but is sometimes used for the passage of kidney stones by the same mechanism of smooth muscle relaxation via alpha antagonism. Benign prostatic hyperplasia (BPH) also known as benign prostatic hypertrophy (technically a misnomer), benign enlargement of the prostate (BEP), and adenofibromyomatous hyperplasia, refers to the increase in size of the prostate in middle-aged and elderly men.

 

Specification:

 

Tests

Specifications

Results

Appearance

White or almost white crystalline powder, slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol.

Conformed

Identification

A: Should conformed

B: Specific rotation: between -17.5 and -20.5°

C: Examine by infrared absorption spectrophotometry, compare the spectrum obtained with reference spectrum should meet the requirement.

D: Should conformed

Conformed

-19.0°

 

 

Conformed

Conformed

Melting point

About 230°C

233.1°C~233.5°C

Loss on drying

Not more than 0.5%

0.03%

Sulphated ash

Not more than 0.1%

0.02%

Heavy metals

Not more than 0.002%

<0.002%

Related substances

Max single impurity

Total impurities

 

Not more than 0.1%

Not more than 0.2%

 

0.001%

0.019%

Enantiomeric impurity

Not more than 0.1%

0.024%

Assay

98.5%~101.0%

99.4%

Residual solvents

Ethanol

 

Not more than 5000ppm

 

400ppm

Microbial limit test

Total number of bacteria

Number of molds

 

Not more than 1000 cfu/gram

Not more than 1000 cfu/gram

 

10 cfu/gram

20 cfu/gram

Conclusion

Complies with IP/BP

 

 Packaging details:

 

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE 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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