| Analysis of concentrations of trace drugs in biological
specimens |
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We have a wide range of techniques, including high-sensitivity
analyses using LC-MS/MS, for measurement of the concentrations of drugs and their
metabolites in body liquids and tissues.
We perform the analyses in our testing
facilities complying with GLP (rated as A in the examination by the organization
for Pharmaceutical Safety Research (July, 1998)).
- Development and validation of methods of measuring concentrations of drugs and their metabolites in biological specimens
- Measurement of concentrations of drugs and their metabolites in specimens of toxicological studies
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Liquid Chromatography-Tandem Mass Spectrometer (LC-MS/MS) |
| Stability test and measurement of physicochemical
properties |
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We are one of the most experienced contract organizations in the field of stability test of bulk and preparations of pharmaceuticals and preparation of procedures for measuring and testing physicochemical properties of pharmaceuticals.
We perform the tests under the control system complying with GLP and provide you with accurate data in such a format that you can use the data as application documentation.
- Preparation of procedures for stability test of bulk and preparations of pharmaceuticals and measurement
- Preparation of procedures for testing physicochemical properties of pharmaceuticals and measurement
- Official tests of pharmaceuticals and raw materials conforming to Japanese Pharmacopoeia
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Storage for stability test |
| Synthesis, separation and purification |
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For analysis of pharmaceuticals, the standard chemicals and standard metabolites of the pharmaceuticals are necessary.
We synthesize the standard chemicals and standard metabolites of pharmaceuticals or separate and purify these substances from drugs and supply the obtained substances after assuring their purities and structures.
- Synthesis, separation and purification of standard chemicals for analysis
- Synthesis, separation and purification of internal standard chemicals for analysis
- Synthesis, separation and purification of trace impurities in bulk
- Synthesis, separation and purification of degradation products for stability test of bulk and preparations of pharmaceuticals
- Synthesis, separation and purification of metabolites in biological specimens
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Capillary electrophoresis equipment |

We can help you in determining the structures
of pharmaceutical substances using our high-level scientific experience and accumulated
fundamental technologies.
- Analysis of structures of pharmaceutical metabolites
- Analysis of structures of pharmaceutical degradation
products
- Analysis of structures of trace impurities in bulk
- Analysis of structures of micro foreign materials in
preparations
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| Quality test of investigational products (GMP) |
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- Quality test of investigational products
- Test for indistinguishability of investigational products
- Standard test of raw materials of investigational products
- Dissolution test of preparations
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| Quality reevaluation and dissolution test by bioequivalence |
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- Establishment of dissolution test conditions and implementation of quality reevaluation test
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Full-automatic dissolution tester |
Marketing of columns for chromatography and reagents
for investigation of
human P450 |
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- Marketing of columns for chromatography
- Reagents for investigation of human P450
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