Research use only. Not for human consumption.
Lab methodology

How we test — methods, limits, reporting.

Every Vivaprime batch ships with a Certificate of Analysis covering identity, purity, residual solvents, and endotoxin. This page walks through what each number on the COA means, how it's measured, and what "good" looks like — so researchers can read a COA independently of marketing framing.

Identity — HPLC-MS + AAA

Confirms the compound is what the label says it is

Every batch is identity-confirmed by two independent methods before release: HPLC-MS (high-performance liquid chromatography with mass-spectrometric detection) to verify the intact molecular mass, and amino-acid analysis (AAA) to confirm the composition matches the reference sequence.

Why two methods: a single retention-time match on HPLC is not enough — isobaric contaminants can co-elute. Mass confirmation rules out wrong-sequence impurities; AAA rules out residual free-amino-acid artifacts from synthesis.

Our spec: Identity confirmed by both HPLC-MS and AAA against reference material.

Purity — reverse-phase HPLC

Measures how much of the peptide is actually the peptide

Reverse-phase HPLC separates the active compound from truncations, deletions, oxidations, and other synthesis-related impurities. Purity is reported as area-percent at 214–220 nm (peptide bond absorbance), integrated over the entire chromatogram.

Reading the chromatogram: the main peak should be sharp and symmetric; sloping shoulders and sidebands indicate closely related impurities that don't separate cleanly. Published purity on each product page reflects the most recent batch COA.

Our spec: Typical spec: ≥ 98.0% area at 214–220 nm. Per-SKU specs published on each product page.

Residual solvents — ICH Q3C

Measures leftover synthesis reagents

Peptide synthesis uses organic solvents — acetonitrile, DMF, DCM, methanol. ICH Q3C defines acceptable residual limits by solvent class (Class 1 prohibited, Class 2 limited, Class 3 flexible). We test against those limits for every batch.

Reporting: the COA lists each solvent measured and its result vs. the ICH limit. 'Not detected' or 'below LOQ' is the expected case for a cleanly processed lot.

Our spec: All tested solvents below ICH Q3C limits by class. Class 1 always 'not detected'.

Endotoxin — LAL

Measures bacterial contamination

Limulus Amebocyte Lysate (LAL) assay detects bacterial endotoxin — a common contamination in peptide manufacturing, especially problematic because endotoxin survives most purification steps.

Reported in EU/mg (endotoxin units per milligram). USP's injectable threshold is 5 EU/kg body-weight-hour for reference material context — we aim far below that for any in-vivo research scenario.

Our spec: Typical spec: < 10 EU/mg. Per-SKU spec published on each product page when applicable.
Seven red flags on a peptide COA

What to look for — and what to question

  1. No batch number. A COA without a batch reference can't be traced back to what you received.
  2. “Mass spec only” identity. Isobaric impurities fool single-method ID. Look for HPLC-MS + a second orthogonal method (AAA or sequencing).
  3. Purity with no chromatogram image. A number without a chromatogram is unverifiable. Reputable COAs include the trace.
  4. Residual solvents “not tested”. Acetonitrile and DMF residues from synthesis are the norm — absence of testing is a gap, not a pass.
  5. Endotoxin omitted. For any peptide that might be used in in-vivo or cell-culture research, endotoxin is a must-have line item.
  6. Identical COAs across batches. Real analytical runs vary slightly; identical numbers across multiple “batches” suggest a stock template, not fresh testing.
  7. Test date missing. A COA without a test date can't be aged against stability timelines.
What we commit to

Every batch. Every SKU. Every time.

Identity, purity, residual solvents, endotoxin, batch number, test date, on the COA. Linked to the pens you received, visible on your order page. If institutional purchasing needs additional method detail or raw chromatograms, we share them on request.

All Vivaprime products are sold for in-vitro research use only. References to analytical methods, spec limits, and regulatory frameworks (ICH Q3C, USP) are for research-context documentation and do not constitute therapeutic, diagnostic, or consumption claims.