Raw Material and Excipient Release Testing Services
- Specializes in testing of pharmaceuticals, active pharmaceutical ingredients (APIs), and excipients.
- Operates under cGMP system management; passed FDA on-site audits twice with "zero deficiencies" as a "release laboratory".
- CNAS-accredited testing capabilities cover the Chinese Pharmacopoeia (Ch.P), United States Pharmacopeia (USP), and European Pharmacopoeia (EP).
- Equipped with professional pharmacopoeial testing instruments and equipment in a 1,400 m² laboratory.
- Testing data complies with FDA 21CFR PART11 data integrity requirements.
Testing Service Items
| Identification | ||
|---|---|---|
| Gas chromatography | Infrared spectrophotometry | UV-visible spectrophotometry |
| Liquid chromatography | TLC | Physical chemical methods |
| Physical and chemical Items | ||
|---|---|---|
| Clarity | Solution color | Saponification value |
| Residue on ignition | Loss on drying | Crystallinity |
| pH | Nitrogen content | Water content |
| Distillation range | Viscosity | Sulfate Ash |
| Melting point | Relative density | Sulfate |
| Optical rotation | Peroxide value | Refractive index |
| Hydroxyl value | Conductivity | Ester value |
| Metal salts | Particle size and particle size distribution - Laser | |
| Heavy Metals | |
|---|---|
| Normal physical and chemical methods | Atomic absorption spectrophotometry |
| Assay | ||
|---|---|---|
| Gas chromatography | Liquid chromatography | UV-visible spectrophotometry |
| Titration | Antibiotic content | Biological potency method |
| Relative Substances | ||
|---|---|---|
| Gas chromatography | Liquid chromatography | TLC |
| UV-visible spectrophotometry | Atomic absorption spectrophotometry | |
| Residual Solvent |
|---|
| Gas chromatography |
| Microbiological Items | ||
|---|---|---|
| Bacterial Endotoxin | Microbial Enumerations tests | Specified Microorganisms |
Testing Capabilities for Common Excipients
| Acids, Bases, and Inorganic Salts | Hydrochloric acid, sulfuric acid, phosphoric acid, sodium hydroxide, potassium hydroxide, aluminum hydroxide, sodium carbonate, sodium bicarbonate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium sulfite, sodium sulfate, disodium edetate, sodium citrate, dipotassium hydrogen phosphate, calcium hydrogen phosphate. |
|---|---|
| Organic Alcohols, Ethers, Acids, and Esters | Ethyl acetate, ethanol, anhydrous ethanol, dimethyl ether, adipic acid, tromethamine, xylitol, glycerol, glycine, alanine, acetic acid, glacial acetic acid, citric acid, palmitic acid, stearic acid. |
| Starches, Sugars, Oils, etc. | Starch (wheat, potato, cassava), soluble starch, maltose, maltitol, fructose, lactose, trehalose, sucralose, sucrose, soybean oil, hydrogenated soybean oil, corn oil, peanut oil, olive oil, coconut oil. |
| Polymers | Polyethylene glycol (300, 400, 600, 1000, 4000, 6000), polysorbate (20, 40, 60, 80, 80II), povidone K30, poloxamer (188, 407). |
| Process Water | Purified water, water for injection, condensed water. |
| APIs and Finished Formulations | Antibiotics (penicillins, cephalosporins, macrolides, aminoglycosides, chloramphenicols, lincomycins, rifamycins, etc.); hormonal drugs; cardiovascular drugs; vitamins, etc. |
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