Analytical Service
Analytical Development & Validation
At the same time as the peptide development process is underway, Yifan Biopharma develops analytical HPLC (High Performance Liquid Chromatography) and UPLC (Ultra Performance Liquid Chromatography) methods and validation tools.
These tools monitor the process for side reactions, required purity standards, and limit any residual related substances in the product. By controlling the final API to ensure the required quality attributes, we will minimize process and degradation products. This affords formulators the maximum labeled drug shelf life under proper storage conditions.
Analysis service type
Method Development & Validation
Release Testing of Drug Substance and Drug Product
Characterization Studies
Stability Studies
Bioanalytical Services
Comprehensive GMP compliant analytical services
Chromatographic methods
- Ultra/High Performance Liquid Chromatography (UHPLC/HPLC) with UV, Fluorescence, CAD Detections)
- Two-Dimensional Ultra High Performance Liquid Chromatography (2D-UHPLC)
- Gas Chromatography (GC)
- Ion Chromatography (IC)
Mass spectrometry methods
- Ultra-High Resolution Mass Spectrometry (ESI-Oritrap)
- High Resolution Mass Spectrometry (ESI-Q-TOF)
- Matrix Assisted Laser Desorption lonization Mass Spectrometry (MALDI-TOF)
- Peptide 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 methods
- Infrared Spectroscopy (IR)
- Ultraviolet / Visible Spectroscopy (UV/VIS)
- Fluorescence Spectroscopy
- Circular Dichroism Spectroscopy (CD)
Other available analytical methods
- Amino Acid Analysis (AAA)
- Peptide Chiral Purity Determination (GC-MS)
- Elemental Analysis (CHN)
- Endotoxins (LAL test)
- Elemental Impurities (ICP-MS)
- Heavy Metals (ICP-MS)
- Polarimetry
- Total Organic Carbon (TOC)
- Total Viable Aerobic Counts (TVC)
Advantage
End-to-end analytical support
From early development to market approval with tailored GMP‑compliant analytics.
Regulatory confidence
Methods and documentation aligned with ICH and global regulatory expectations.
Data integrity, digitally assured
LIMS, CDS, and validated digital systems meeting the CSV standards.
Analytical experience
More than 10years of industry experience setting analytical standards in peptides.