Active Pharmaceutical Ingredient and Excipient Testing

Active pharmaceutical ingredients (APIs) are raw materials for pharmaceutical manufacturing and are the active ingredients of various preparations. Excipients are medicinal materials added to the prescription to solve the formability, effectiveness, stability and safety of the preparation. APIs and excipients are the main components of drugs, which determine the quality and safety of drugs.

The active pharmaceutical ingredient and excipient testing is an important part of drug quality and safety control. Good testing can conduct component analysis, content testing, physical and chemical index testing and biological safety testing on the materials used in drug production to ensure that the materials comply with relevant industry standards and regulations, thereby guaranteeing the safety and effectiveness of drugs.

STEMart provides the active pharmaceutical ingredient and excipient testing services according to United States Pharmacopeia (USP) and European Pharmacopeia (EP) standards to ensure the quality and safety of pharmaceutical products.

Test Samples

Sorbitol, mannitol, polyethylene glycol, sodium hydroxide, sodium chloride, disodium hydrogen phosphate, citric acid, sodium citrate, glycine, histidine, cellulose, lactose, trehalose, glucose, glycerol, sodium carboxymethyl starch, etc.

Service Items

Component analysis

Content testing

• Moisture
• Chloride
• Sulfate
• Iron salt
• Ammonium salt
• Heavy metal
• Arsenic salt

Physical and chemical index testing

• pH
• Osmotic pressure
• Optical activity
• Fusing point
• Drying loss
• Burning residue
• Boiling point
• Specific gravity
• Refractive index
• Stability

Biosafety testing

• Microbial limit
• Bacterial endotoxin
• Toxicity test

For more information about our active pharmaceutical ingredient and excipient testing services, please contact us.