Drug Analysis Service

Creative BioMart provides drug analysis service for pre-clinical drugs and natural products on their physical and chemical properties. Our services include three main assays: pre-clinical pharmaceutical property analysis, pharmacokinetics analysis & bioanalysis, and natural product analysis.

Our pre-clinical pharmaceutical property analysis service aims at identifying compound impurities, evaluating packages, and providing other quality tests and methodology establishment. Impurities stand for the substances with no therapeutic function in the drugs. They can be toxic to human, or nontoxic but affect the stability and efficiency of drugs. Impurities can be introduced through the production process (intermediate, by-product, etc.) or during storage (humidity, temperature, etc.). We can accurately determine whether impurities exceed the impurity limit of drugs, thereby ensuring drug safety. We can also perform stress test, acceleration test, and long-term test to determine the potential feasibility of target drugs for clinical application.

Pharmacokinetics analysis & bioanalysis includes two parts: in vitro absorption, distribution, metabolism and elimination analysis, and in vivo metabolism and dynamics analysis. We can help you determine kinetic constants such as logD and pKa, understand metabolic process (by identification of metabolites, determination of metabolic enzyme phenotype, etc.) and conduct animal experiment on rodents to evaluate in vivo drug absorption and distribution.

Natural product analysis services include component identification, metabolomics analysis and establishment of methodologies, to help you gain a better understanding of the composition and potential therapeutic effect of natural products.

Pre-clinical pharmaceutical property analysis service items and methods

Item	Method
Confirmation of compound structure	API4000-Qtrap Liquid Chromatography-Mass Spectrometry (LC-MS/MS) Nuclear Magnetic Resonance (NMR): Bruker 400/600M Infrared Spectrometer (FTIR) Ultraviolet Spectrometer (UVS) Waters High Resolution Mass Spectrometry (HRMS) Elemental Analyzer DSC-TG/DTA
Separation, purification, identification and structural explanation of toxic impurities and degradation products	Waters MS guided auto-purification system MS NMR: Bruker 400/600M FTIR UVS Waters HRMS Elemental Analyzer DSC-TG/DTA
Standard reference material calibration	NMR Potentiometric titrimeter
Drug content measurement and analysis methodology establishment and validation	Waters Ultra Performance Liquid Chromatography (UPLC) Quattro Premier XE API-4000Qtrap LC-MS/MS Waters High Performance Liquid Chromatography (HPLC) (ultraviolet, fluorescent, PDA, ELSD) Varian Gas Chromatography (GC) (FID, TCD, ECD) Varian Gas Chromatography-Mass Spectrometry (GC-MS/MS)
Genotoxic impurities content measurement and analysis methodology establishment and validation	Waters UPLC Quattro Premier XE API-4000Qtrap LC-MS/MS Waters HPLC (ultraviolet, fluorescent, PDA, ELSD) Varian GC (FID, TCD, ECD) Varian GC-MS/MS
Residual solvent analysis methodology establishment and validation	Varian HS-GC(FID, TCD, ECD) Varian HS-GC-MS/MS
Stress test	Constant temperature & humidity incubator Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Acceleration test	Constant temperature & humidity incubator Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Long-term test	Constant temperature & humidity incubator Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Accessory compatibility	Constant temperature & humidity incubator Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Package and container selection	Constant temperature & humidity incubator Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)

Pharmacokinetics analysis & Bioanalysis service items and methods

Category	Item	Method
Bioanalysis	Single component or multi-component bioanalytical methodology establishment	Waters UPLC Quattro Premier XE API-4000Qtrap Waters UPLC XevoTQ-S LC-MS/MS
	Entire of partial bioanalysis method validation
	Pharmacokinetics in vitro sample analysis
	Pharmacokinetics in vivo sample analysis
	Clinical sample analysis
In vitro absorption, distribution, metabolism and elimination study	Determination of log D and pKa	Waters UPLC Quattro Premier XE API-4000Qtrap Waters UPLC Xevo TQ-S LC-MS/MS Waters XevoG-2 Q-TOF
	Chemical stability & plasma stability analysis
	Interspecific plasma protein binding capacity test
	PAMPA permeability evaluation
	Interspecific biological metabolism stability analysis
	Determination of metabolic enzyme phenotype
	CYP450 inhibition and induction analysis
In vivo metabolism and dynamics study	Interspecific basic pharmacokinetics study	Waters UPLC Quattro Premier XE API-4000Qtrap Waters UPLC Xevo TQ-S LC-MS/MS Waters XevoG-2 Q-TOF
	Bioavailability
	Rodent target organ absorption and distribution study
	Material balance study
	Metabolite identification (phase I and phase II metabolism)
	Bioequivalence
	Metabolomics study

Natural product analysis service items and methods

Item	Method
Natural product component identification	HRMS: Waters XevoG2-S Q-TOF
Natural product multi-component simultaneous quantification analysis method establishment, methodology validation and content detection	Waters UPLC Quattro Premier XE Waters UPLC XevoTQ-S LC-MS/MS
Multi-component blood drug concentration test, methodology establishment, methodology validation and content detection	Waters UPLC Quattro Premier XE Waters UPLC XevoTQ-S LC-MS/MS
Natural product metabolite study	Waters Xevo G2-S Q-TOF
Natural product metabolomics study	Waters Xevo G2-S Q-TOF