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Peptide CMC

Peptide Discovery

Peptide CMC

Peptide Conjugation

Amino Acid

Case Study

Analytical

API

Drug Product

Analytical

CMC Filing

WuXi STA has a dedicated peptide analytical team of scientists with extensive experience and expertise to support all peptide analysis at all development phases.  Equipped with state-of-the-art instruments and located in the same site with API process development team, our peptide analytical service will streamline your peptide development with customized, flexible and integrated analytical solution.

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Our services include

Method development and validation

Stability study: forced degradation study, accelerated and long-term stability study under R&D and GMP environment

Purity and Assay, residual solvents, moisture, cation content, anion content, aggregation content, elemental impurities

Microbiology safety: endotoxin for limit and quantitation and bioburden for microbial limit test, microbe ID and strain typing

Amino acid analysis and enantiomeric purity: acid hydrolysis and derivatization followed by LC-MS analysis to accurately evaluate the amino acid ratio and D-isomer impurity amount in peptide sequence

Identity by peptide mapping: enzymatic digestion followed by LC-MS analysis for characterization and confirmation of peptide API

Identity by molecular weight and sequencing: 2D UPLC coupled with Q-TOF and MALDI-TOF/TOF HRMS for accurate MW and sequence determination

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Unique Peptide enantiomeric purity test

Accurately determine the peptide enantiomeric purity was difficult. Peptides with different amino acid isomers have the same physicochemical properties that cannot be analyzed intact; free amino acid does not have good retention for HPLC-UV analysis; peptide contain multiple amino acids that interfere with each other during analysis.  We have capability of enantiomeric purity analysis for all 19 isomeric natural amino acids (Asparagine and Aspartic acid, Glutamine and Glutamic acid will be reported together) and Ornithine.

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Chromatographic Techniques

High Performance Liquid Chromatography (HPLC)

High Performance Liquid Chromatography coupled with Mass Spectrometry (HPLC-MS)

Ultra-High Performance Liquid Chromatography (UHPLC - available detectors: UV, CAD, MALS)

Ultra-High Performance Liquid Chromatography coupled with Mass Spectrometry (UHPLC-MS)

2D Ultra-High Performance Liquide Chromatography (2D-UPLC)

Gas Chromatography (GC)

Ion Chromatography (IC)

Thin Layer Chromatography (TLC)

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Mass Spectrometry Techniques

Electrospray Mass Spectrometry (ESI-MS Orbitrap & Q-TOF)

Matrix Assisted Laser Desorption/Ionization Mass Spectrometry (MALDI-TOF/TOF)

Tandem Mass Spectrometry Sequencing (Q-TOF, Orbitrap & MALDI-MS/MS)

2D Ultra-High Performance Liquide Chromatography coupled with HRMS (Q-TOF)

Mass Spectrometry Purity and impurity quantitation (Q-TOF)

Gas Chromatography Coupled with Mass Spectrometer (GC-MS)

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Spectroscopic Techniques

Infrared Spectroscopy (IR)

UV/VIS Spectroscopy

Tm (UV melting curve)

Circular Dichroism Spectroscopy (CD)

Nuclear Magnetic Resonance Spectroscopy (1H, 13C, 31P & 19F - NMR)

Other Techniques

Amino Acid Analysis (AAA)

Elemental Analysis (CHN)

Enantiomeric Purity

Polarimetry

Refractometry

Titration

Turbidimetry

Osmolality

Total Organic Carbon (TOC)

Total Viable Aerobic Counts

Endotoxins (LAL-test)

Heavy Metals

Sulfated Ash

Residue on Ignition

Polydispersity