Analysis
-
Microbial Testing
-
Physical Property Characterization
-
Potential Genotoxic Impurity (PGI) Assessment and Analysis
-
IPC and Release Method Development/Method Validation
-
Nitrosamine Assessment and Determination
-
Stability Studies (Hold Time, Developmental, ICH)
-
Reference Standard Characterization
Qualification and Aliquotation -
Stress Testing/Forced Degradation
-
Characterization of Aggregation State and Oligomers
-
Impurity/Degradant Isolation, Structure Elucidation and Profiling
Analytical Services
Range of GMP Compliance
-
Microbial Testing
-
Physical Property Characterization
-
Potential Genotoxic Impurity (PGI) Assessment and Analysis
-
IPC and Release Method Development/Method Validation
-
Nitrosamine Assessment and Determination
-
Stability Studies (Hold Time, Developmental, ICH)
-
Reference Standard Characterization
Qualification and Aliquotation -
Stress Testing/Forced Degradation
-
Characterization of Aggregation State and Oligomers
-
Impurity/Degradant Isolation, Structure Elucidation and Profiling
Global Quality Standard
Our facilities are regularly audited by the US FDA, NMPA, and other prominent regulatory authorities. Our extensive regulatory filing experience for commercially approved products shall assure our global partners are in full compliance in their filing and interactions with various regulatory agencies.
Analytical Techniques
-
Chromatographic Techniques
-
Mass Spectrometry Techniques
-
Spectroscopic Techniques
-
Other Techniques
-
Chromatographic Techniques
Ultra/High Performance Liquid Chromatography (UHPLC/HPLC) with UV, Fluorescence, CAD Detections)
Two-Dimensional Ultra High Performance Liquid Chromatography (2D-UHPLC)
Gas Chromatography (GC)
lon Chromatography (IC)
-
Mass Spectrometry Techniques
Ultra-High Resolution Mass Spectrometry (ESI-Oritrap)
High Resolution Mass Spectrometry (ESI-Q-TOF)
Matrix Assisted Laser Desorption lonization Mass Spectrometry (MALDI-TOF)
Peptide and Oligonucleotide Sequencing (ESI-MS/MS)
Ultra/High Performance Liquid Chromatography Coupled with Mass Spectrometry (UHPLC-MS/MS)
Two-Dimensional Ultra High Performance Liquid Chromatography Coupled with Mass Spectrometry (2D-HPLC-MS/MS)
Gas Chromatography Coupled with Mass Spectrometry (GC-MS)
-
Spectroscopic Techniques
Infrared Spectroscopy (IR)
Ultraviolet/Visible Spectroscopy (UV/VIS)
Fluorescence Spectroscopy (FL)
Circular Dichroism Spectroscopy (CD)
Oligonucleotide Melting Temperature (Tm)
-
Other Techniques
Amino Acid Analysis (AAA)
Peptide Chiral Purity Determination (GC-MS)
Elemental Analysis (CHN)
Endotoxin (LAL test)
Elemental Impurities (ICP-MS)
Polarimetry
Titration (Kal-Fischer vol/coul.)
