Complete Analytical Testing Panel

The gold standard for peptide purity quantification — accurate to 0.05% relative impurity.

• ⬡Reverse-phase HPLC with UV detection at 220nm and 254nm
• ⬡Quantifies purity from 85% to 99.9%+ with chromatogram
• ⬡Identifies and quantifies related impurities and degradants
• ⬡USP <621> compliant method with validated reference standards
• ⬡Full chromatogram included in COA PDF report
• ⬡Shimadzu Prominence system with Kinetex C18 column

Definitive molecular identity confirmation at sub-picomole sensitivity — eliminates substitution fraud.

• ⬡Waters ACQUITY UPLC with TQ-S mass spectrometer
• ⬡Electrospray ionization (ESI) in positive and negative modes
• ⬡Confirms molecular formula, isotope pattern, and fragmentation
• ⬡Detects modifications: disulfide bonds, acetylation, PEGylation
• ⬡Mass range 200–3000 m/z covering all common peptides
• ⬡ICH Q6B / USP <1058> compliant methodology

Eight elemental impurities tested at sub-ppb detection levels per USP oral and parenteral limits.

• ⬡Agilent 7900 ICP-MS with collision/reaction cell technology
• ⬡Tests 8 elements: Pb, As, Hg, Cd, Cu, Ni, Cr, Co
• ⬡Sub-ppb (parts per billion) detection sensitivity
• ⬡Acid digestion or aqueous dilution sample preparation
• ⬡Multi-element certified standard calibration
• ⬡Rhodium and Germanium internal standard spike correction

USP-compliant microbial limits and kinetic LAL endotoxin assay for injectable-grade documentation.

• ⬡Total aerobic microbial count (TAMC) per USP <61>
• ⬡Yeast and mold count (TYMC) per USP <62>
• ⬡Kinetic turbidimetric LAL endotoxin assay per USP <85>
• ⬡Endotoxin limit of detection: 0.005 EU/mL
• ⬡Acceptance criteria per USP Category 2 microbial limits
• ⬡Sterility testing available on request (USP <71>)

GC headspace analysis for 50+ ICH Q3C residual solvents including TFA, ACN, DMF, and more.

• ⬡Agilent 7890B GC with FID detection and headspace sampler
• ⬡Tests acetonitrile, TFA, DMF, DCM, and 50+ Class 2/3 solvents
• ⬡ICH Q3C and USP <467> compliant method
• ⬡Class 1 solvent screening also available
• ⬡Quantitative results with acceptance limit comparison
• ⬡Critical for compounds synthesized via Fmoc/Boc-SPPS routes

Bespoke panels for multi-compound batches, stability studies, method development, and volume programs.

• ⬡Multi-compound batch testing with volume discounts
• ⬡Stability testing programs (ICH conditions)
• ⬡Client-specific method development and validation
• ⬡Forced degradation and stress testing studies
• ⬡Dedicated project management for ongoing programs
• ⬡Priority scheduling and dedicated lab contact