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

• Appearance White or almost white crystalline powder, slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol (Results: Confirm)
• Identification
  • A: Should (Results: Confirm)
  • B: Specific rotation: between -17.5 and -20.5° (Results: -19.0°)
  • C: Examine by infrared absorption spectrophotometry, compare the spectrum obtained with reference spectrum should meet the requirement (Results: Confirm)
  • D: Should confirmed (Results: Confirm)
• Melting point About 230°C (Result: 233.1°C~233.5°C)
• Loss on drying Not more than 0.5% (Result: 0.03%)
• Sulphated ash Not more than 0.1% (Result: 0.02%)
• Heavy metals Not more than 0.002% (Result: <0.002%)
• Related substances
  • Max single impurity Not more than 0.1% (Result: 0.001%)
  • Total impurities Not more than 0.1% (Result: 0.019%)
• Enantiomeric impurity Not more than 0.1% (Result: 0.024%)
• Assay 98.5%~101.0% (Result: 99.4%)
• Residual solvents
  • ethanol Not more than 5000ppm (Result: 400ppm)
• Microbial limit test
  • Total number of bacteria Not more than 1000 cfu/gram (Result: 10 cfu/gram)
  • Number of molds Not more than 1000 cfu/gram (Result: 20 cfu/gram)
• Conclusion Complies with IP/BP