Testing methods.
Six analytical methods covering the full lifecycle of a research compound — from synthesis verification to stability monitoring. Each method is performed under defined SOPs and reviewed by a second analyst.
HPLC Purity Analysis
Reverse-phase chromatography for quantitative purity reporting.
- Detection limit: 0.05% of total area
- UV diode-array detection from 200–400 nm
- Reference standard comparison for every analyte
- Result reported as % area purity
Mass Spectrometry
ESI-MS for compound identity confirmation against the theoretical mass.
- Electrospray ionization, positive and negative mode
- Mass accuracy ±0.1 Da on monoisotopic peptides
- Identity confirmed at observed vs theoretical match
- Full spectrum included as supplementary file
Microbial Limit & Endotoxin
Bioburden and bacterial endotoxin testing for sterile reconstitution-grade material.
- Total aerobic microbial count (TAMC)
- Total combined yeast and mold count (TYMC)
- Endotoxin via LAL kinetic-chromogenic method
- Reported in CFU/g and EU/mg respectively
Residual Solvents
Headspace GC-FID for residual organic solvents from synthesis.
- Class 1, 2, and 3 solvents per ICH Q3C
- Limit of detection at 10% of permitted daily exposure
- Reported in ppm with individual solvent breakdown
Water Content
Karl Fischer titration for moisture content in lyophilized material.
- Coulometric titration for trace water
- Sensitivity to 10 µg H₂O
- Reported as % w/w
Stability Studies
Accelerated and real-time stability testing per ICH Q1A.
- Three storage conditions (25°C / 40°C / -20°C)
- Sample pull intervals at 0, 1, 3, 6, 12 months
- HPLC purity at each pull point
- Stability report issued at end of study
Need a method that isn't listed?
We accept method-development requests for compounds where a standard pharmacopeial method does not exist. Reach out and we will scope a study.