Research and Analysis of Impurities in Active Pharmaceutical Ingredients

Active pharmaceutical ingredients (APIs) are chemical substances or compounds used in the manufacture of medicines, which are the active ingredients in medicines. APIs are usually prepared by chemical synthesis, plant extraction or biotechnology, generally in powder, crystal, extract and other states.

The quality of APIs has an important influence on drug quality control. The research and analysis of impurities in APIs is one of the key elements in quality assurance of APIs, and is also an important evaluation index to ensure the safety and controllability of drugs. Impurities contained in APIs will reduce the efficacy and affect the stability of the drug. Some impurities are even harmful to human health or produce other toxic and side effects. Therefore, it is very important to analyze the impurities in the APIs and control the purity of the APIs to ensure the safety and effectiveness of the drugs.

STEMart provides comprehensive impurity testing services for active pharmaceutical ingredients (APIs) to help you research and analyze the impurities such as inorganic impurities, organic impurities, and residual solvents to ensure the quality and safety of APIs.

Test Samples

Vigagliptin, northromycin hydrochloride, atorvastatin calcium, erythromycin, aluminum hydroxide, magnesium trisilicate, aspirin, chloramphenicol, caffeine and other active pharmaceutical ingredients

Test Items

• Composition analysis and content detection of impurities
• Classification and identification of impurities
• Physical and chemical property test
  • Solubility
  • Permeability
  • Crystal form
  • Particle size
  • pH
  • Drug dissolution and release
• Microbial detection
  • Microbial limit
  • Bacterial endotoxin

For more information about our impurity testing services for active pharmaceutical ingredients, please contact us.