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Pharmaceutical Research
IPHASE provides professional pharmaceutical research services
IPHASE has rich experience in chemical analysis and stability research. We promise to carry out chemical analysis and stability research for customers in full compliance with the guidance of the International Coordinating Organization (ICH) and the GLP/cGMP management requirements of domestic and foreign pharmaceutical regulatory agencies.
service content
Methodological establishment: impurity/assay/potency, chiral method, solvent residue, quantitative preparation analysis
● Methodology confirmation
● Methodology transfer
● Stability test: I - IV area divided by ICH, light stability, stability index analysis
● Delivery inspection: API, pharmaceutical products, product inspection from pre-clinical to commercialization
● Identification: structure/purity, reference standard, impurity identification
● Microbiology: bacterial endotoxin, antibacterial effect, antibiotic titer