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.

Drug Analysis Service

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
  1. API4000-Qtrap Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
  2. Nuclear Magnetic Resonance (NMR): Bruker 400/600M
  3. Infrared Spectrometer (FTIR)
  4. Ultraviolet Spectrometer (UVS)
  5. Waters High Resolution Mass Spectrometry (HRMS)
  6. Elemental Analyzer
  7. DSC-TG/DTA
Separation, purification, identification and structural explanation of toxic impurities and degradation products
  1. Waters MS guided auto-purification system
  2. MS
  3. NMR: Bruker 400/600M
  4. FTIR
  5. UVS
  6. Waters HRMS
  7. Elemental Analyzer
  8. DSC-TG/DTA
Standard reference material calibration
  1. NMR
  2. Potentiometric titrimeter
Drug content measurement and analysis methodology establishment and validation
  1. Waters Ultra Performance Liquid Chromatography (UPLC) Quattro Premier XE
  2. API-4000Qtrap LC-MS/MS
  3. Waters High Performance Liquid Chromatography (HPLC) (ultraviolet, fluorescent, PDA, ELSD)
  4. Varian Gas Chromatography (GC) (FID, TCD, ECD)
  5. Varian Gas Chromatography-Mass Spectrometry (GC-MS/MS)
Genotoxic impurities content measurement and analysis methodology establishment and validation
  1. Waters UPLC Quattro Premier XE
  2. API-4000Qtrap LC-MS/MS
  3. Waters HPLC (ultraviolet, fluorescent, PDA, ELSD)
  4. Varian GC (FID, TCD, ECD)
  5. Varian GC-MS/MS
Residual solvent analysis methodology establishment and validation
  1. Varian HS-GC(FID, TCD, ECD)
  2. Varian HS-GC-MS/MS
Stress test
  1. Constant temperature & humidity incubator
  2. Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Acceleration test
  1. Constant temperature & humidity incubator
  2. Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Long-term test
  1. Constant temperature & humidity incubator
  2. Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Accessory compatibility
  1. Constant temperature & humidity incubator
  2. Waters HPLC (ultraviolet, fluorescence, PDA, ELSD)
Package and container selection
  1. Constant temperature & humidity incubator
  2. 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
  1. Waters UPLC Quattro Premier XE
  2. API-4000Qtrap
  3. Waters UPLC XevoTQ-S
  4. 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
  1. Waters UPLC Quattro Premier XE
  2. API-4000Qtrap
  3. Waters UPLC Xevo TQ-S
  4. LC-MS/MS
  5. 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
  1. Waters UPLC Quattro Premier XE
  2. API-4000Qtrap
  3. Waters UPLC Xevo TQ-S
  4. LC-MS/MS
  5. 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
  1. Waters UPLC Quattro Premier XE
  2. Waters UPLC XevoTQ-S LC-MS/MS
Multi-component blood drug concentration test, methodology establishment, methodology validation and content detection
  1. Waters UPLC Quattro Premier XE
  2. 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
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