We can now conduct TK and PK measurements using LC-MS/MS, not only at our Pharmacokinetic and Bioanalysis Center in Wakayama, but also on-site at our Drug Safety Research Laboratories in Kagoshima.
Tests and Assays Offered
Examples of dosage forms handled
Active pharmaceutical ingredients, solutions, granules, eye ointments, suspensions, emulsions, suppositories,
powders, tablets, injections, patches, eye drops, ointments,
vaccines
Characterization and Stability Studies
Typical measurement parameters
Time to completion: 4 weeks (COA within 3 weeks)
Validation of Characterization Methods (for purity and assay tests using HPLC)
Typical measurement parameters
Time to completion: 4 weeks
Validation of Dose Formulation Concentration Method
Typical measurement parameters
Time to completion: 4 weeks
Fourier Transform Infrared Spectroscopy (FTIR)
Identification Test
Equipment: FTIR (Fourier transform infrared spectrophotometer)
Manufacturer: Shimadzu Model: FTIR-8400
Advantages:
Advantages:
Ultra High Performance Liquid Chromatography
Purity, assay
Equipment: UHPLC (Ultra High Performance Liquid Chromatograph)
Manufacturer: Shimadzu Models: 20A, 30A
Advantages:
Water determination (Karl Fischer Method)
Moisture content
Equipment: Moisture titrator
Manufacturer: Kyoto Electronics Manufacturing
Type:
Advantages:
Ion chromatographic method
Ion analysis, amino acid analysis
Equipment: Ion chromatograph (IC)
Manufacturer: Thermo Fisher Scientific Model: ICS-3000
Advantages:
Trifluoroacetic acid measurement (residual solvent)
Even with an injection volume of 1/3, the limit of quantification is 4 times lower.
Stability Studies
Samples are stored at the specified conditions, and the test items are conducted at each time point.
Samples
Active pharmaceutical ingredients, solutions, granules, eye ointments, suspensions, emulsions, plasters, suppositories, tablets, injections, eye drops, ointments.
Storage Capabilities
Storage Equipment |
Performance |
|
Temperature ranges |
Humidity ranges |
|
Temperature and humidity controlled cabinets |
5 to to 85°C |
40 to 95% |
-20 to 100°C |
30 to 98% |
Storage rooms |
Temperature ranges |
Humidity ranges |
Ordinary temperature room |
15 to 25°C |
80% |
Refrigeration room |
2 to 8°C |
- |
Freezer room |
-30 to -10°C |
- |
LC-MS/MS method
API4000 LC-MS / MS system: 3 instruments
Triple Quad 6500 LC-MS/MS system: 2 instruments