// THE 7X PROTOCOL

Seven checks. One traceable answer.

A fixed, finished-vial panel: no tiers, no add-ons. Every sample receives all seven checks. Below: what each check answers, the exact methods and their validation status, and the quality system that stands behind every report.

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// THE SEVEN CHECKS

What every sample is tested for

Each layer answers one specific question. Every result identifies the sample, method, specification source, quality status, and technical reviewer.

LAYER

Homogeneity Profiling

RP-HPLC 214nm (USP <621>)

QUESTION

What proportion of detected chromatographic area is the primary component?

RP-HPLC at 214nm isolates the main peak from related substances at the peptide-bond absorbance wavelength.

METHOD STATUSValidated in-house

LAYER

Molecular Mass Fingerprinting

LC-MS/MS (ESI+)

QUESTION

Is the expected compound present?

LC-MS/MS confirms exact monoisotopic mass and fragmentation identity, ±1 Da. Identity consistent with expected mass.

METHOD STATUSValidated in-house

LAYER

Net Peptide Mass Quantitation

Quantitative HPLC vs reference std

QUESTION

How much target peptide is present per vial?

Quantitative HPLC against a qualified reference standard, stripping moisture, salts, and counter-ions like TFA. Reported as mg per vial.

METHOD STATUSValidated in-house

LAYER

Bacterial Endotoxin

Kinetic chromogenic LAL

QUESTION

What endotoxin activity was measured?

Kinetic chromogenic LAL (USP <85>). Reported in EU/mL and EU/mg against a stated limit.

METHOD STATUSVerified compendial

LAYER

Elemental Catalytic Sweep

ICP-MS (USP <232>/<233>)

QUESTION

Were specified elements detected, and at what levels?

ICP-MS (USP <232>/<233>) for Pb, As, Cd, Hg at sub-ppb. Each element: result, unit, LOQ, and specification source.

METHOD STATUSVerified compendial

LAYER

Microbial Quality

Rapid molecular microarray screen

QUESTION

Were viable microorganisms detected?

Rapid molecular microarray screen. This is NOT a USP <71> sterility test. Reported as CFU against a limit.

METHOD STATUSResearch screen

LAYER

Post-Reconstitution Stability

Forced-degradation stability

QUESTION

Are separately prepared vials consistent, and is the reconstituted solution stable?

≥3 independent vials: individual results, mean, SD, CV. Post-reconstitution pH, clarity, and 24h forced-degradation kinetics.

METHOD STATUSResearch screen

// METHOD STATUS MATRIX

Methods & validation status

Each row is one of the seven layers above. We identify which methods are validated in-house, which compendial procedures were verified for use, and which are research screens. This status appears beside each reported result on every COA.

Validated in-house

Method validated by Axiom for the stated analyte, matrix, and range.

Verified compendial

An established compendial procedure (e.g. USP) verified as suitable for use.

Research screen

An informative screening method, not a validated or compendial release assay.

Layer · Method	Reference	Instrument	Status	Range	LOQ
01RP-HPLC Purity	USP <621>	Agilent 1260 Infinity II	Validated in-house	0.1–100%	0.05%
02LC-MS/MS Identity	Intact mass + MS/MS	Thermo Orbitrap Exploris	Validated in-house	±1 Da	N/A
03Net Peptide Content	Quant. HPLC vs ref std	Agilent 1260 + AAA confirm	Validated in-house	0.1–50 mg	0.01 mg
04Bacterial Endotoxin	USP <85>	Kinetic chromogenic LAL	Verified compendial	0.005–50 EU/mL	0.005 EU/mL
05Elemental Impurities	USP <232>/<233>	Agilent 7850 ICP-MS	Verified compendial	0.01–1000 ppb	0.01 ppb
06Rapid Microbial Screen	Molecular microarray	Rapid detection panel	Research screen	0–10⁴ CFU	1 CFU
07Forced-Degradation Stability	Post-reconstitution kinetics	HPLC time-course, pH meter	Research screen	0–100% degr.	0.1%

ACCREDITATION STATUS

Axiom Analytics does not currently hold ISO/IEC 17025 accreditation. Testing is conducted under a documented quality system, and the method-validation status is identified beside each reported result. This statement will be updated upon accreditation.

// QUALITY & TRUST CENTER

Accreditation status, stated plainly

No decorative badges, no claims beyond the evidence. Here is the quality system behind every result, and exactly where we stand on accreditation.

Documented QMS

SOPs, chain-of-custody, equipment qualification, and a controlled retest policy, applied to every sample.

Method Validation

Each method states analyte, matrix, range, specificity, precision, accuracy, quantitation limit, and status.

Reference Standards

Qualified reference standards with documented traceability. Blanks, controls, and suitability checks on every run.

Independent Review

Every COA passes analyst → independent technical reviewer → release. Two pairs of eyes, signed.

Correction Policy

Amendments create a new version; prior versions are superseded but retained. Full revision history is public on verify.

Zero Conflicts

Axiom owns zero retail brands and zero inventory. We are strictly a data-verification laboratory.

One vial. One flat price. All seven checks.

No tiers, no add-ons, no conflicts of interest. Results in about two days.

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