Analytical Standards
How Every Lot Is Tested
Identity, purity, water content, counterion residue, endotoxin, and appearance. Six independent gates, every lot, every release — documented on a Certificate of Analysis a practitioner can request and verify.
6
Release tests per lot
≥99%
Purity specification
<0.25
EU/mg endotoxin limit
100%
Lots with 3rd-party COA
The Release Workflow
Six gates from synthesis to released lot
Stage 1
Identity — Mass Spectrometry
Confirms the molecular structure matches the declared sequence.
- Method
- ESI-MS / MALDI-TOF
- Specification
- Observed mass within ±1 Da of theoretical mass
Why this matters
Identity confirmation is the first gate. Without verified mass, no other testing matters. A failed identity test invalidates the entire lot.
Stage 2
Purity — HPLC
Reverse-phase HPLC quantifies the active peptide against impurities and degradation products.
- Method
- RP-HPLC, UV detection at 214 nm
- Specification
- ≥99.0% area under curve, single dominant peak
Why this matters
Purity is the headline number on every COA. It tells a practitioner what fraction of the lot is the intended molecule versus synthesis byproducts or breakdown products.
Stage 3
Water Content — Karl Fischer
Measures residual water in the lyophilized cake.
- Method
- Coulometric Karl Fischer titration
- Specification
- ≤5.0% w/w (compound-dependent)
Why this matters
Water content affects shelf-life stability and reconstitution behavior. High moisture indicates incomplete lyophilization and a shorter useful life.
Stage 4
Acetate Content — Ion Chromatography
Quantifies trifluoroacetate / acetate counterion residue from synthesis.
- Method
- Ion chromatography with conductivity detection
- Specification
- Within compound-specific declared range
Why this matters
Counterion content affects the active peptide mass per declared weight. Without it, dosing calculations drift from labeled values.
Stage 5
Endotoxin — LAL
Bacterial endotoxin testing per USP <85>.
- Method
- Kinetic chromogenic Limulus Amebocyte Lysate
- Specification
- <0.25 EU/mg (research-grade threshold)
Why this matters
Endotoxin is the primary biological contamination risk in lyophilized peptides. Levels above threshold indicate poor process control during synthesis or fill.
Stage 6
Sterility & Appearance
Visual inspection of the lyophilized cake and reconstitution profile.
- Method
- Visual cake evaluation, reconstitution time
- Specification
- Uniform white-to-off-white cake, full dissolution
Why this matters
Cake appearance is the fastest indicator of fill anomalies, partial collapse, or moisture ingress during stoppering. Reconstitution profile validates real-world usability.
Operating Principles
What sits behind the numbers
Independent verification
Identity, purity, and endotoxin are confirmed by a third-party laboratory unaffiliated with synthesis. Internal QC results are never the sole basis for release.
Lot-specific COA
Every released lot ships with a Certificate of Analysis bearing the lot number, test dates, methods, specifications, and observed results.
Retained samples
A retained sample from every lot is held in controlled storage for follow-up testing should a question arise post-release.
Out-of-specification handling
Lots failing any release test are quarantined, investigated, and either reworked under documented procedures or destroyed. No OOS lot is released.
The document trail per lot
- ›Synthesis record with sequence and scale
- ›Mass spectrometry confirmation chromatogram
- ›HPLC purity chromatogram with peak integration
- ›Karl Fischer water content result
- ›Ion chromatography counterion result
- ›Third-party endotoxin (LAL) report
- ›Visual fill inspection and reconstitution log
- ›Final Certificate of Analysis signed by QA
Request a sample COA
Practitioners can request a representative Certificate of Analysis before placing any evaluation order. Specify the compound of interest and we will send the most recent released lot's COA from our reference set.
See also: Editorial Methodology · Lot Transparency · Facility & Operations