DEVELOPMENT AND VALIDATE OF ANALYTICAL METHODS

We use analytical instruments which ensure data integrity (DI), and we achieve reliable quality control by validating analytical data from various viewpoints. We also support analytical method developments from the initial development stage to the commercial production stage. In addition, our plant is also fully equipped with experimental facilities for high potency active pharmaceutical ingredients.

DEVELOPMENT AND VALIDATE OF ANALYTICAL METHODS

Developments of physico-chemical testing, microbial testing and physical properties tests (XRD, particle size distribution)
Analytical method validation
Setting specifications and testing methods
Quality test and quality evaluation for investigational APIs and related compounds
Stability test for investigational APIs and stability test for NDA

Analysis instruments

HPLC, UHPLC, LC/GC-MS, KF Water Content Measurement Device, NMR, Infrared Spectroscopy (IR), Ultra violet-visible spectrophotometer (UV), Particle size analyzer (for DRY/ for WET type), Powder X-ray Diffraction (XRD), ICP-MS, ICP-AES, potentiometric titrator, optical rotation detector, Kjeldahl nitrogen determination apparatus, Microorganism/Bacterium Number Measurement Device, stability , Differential Thermal Analyzer (DGA/DSC), Reaction Calorimeter

PHARMACEUTICAL
BUSINESS

We provide process development, method development and validation, and manufacturing services for intermediates and APIs (Active Pharmaceutical Ingredients), which have been developed by pharmaceutical companies, academia, and venture companies. Our clients can rely on our superior technologies and quality assurance system which have been developed over many years of experience in the industry.
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COSMETIC
BUSINESS

We offer sourcing, contract manufacturing and sales services of cosmetic chemicals to send beauty and moisture to customers around the world.
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CHEMICAL
BUSINESS

We supply high quality raw materials for chemicals from companies inside and outside of Japan leveraging our technologies and supply network.
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