Attest214
The Standard

What we test for, and what each test can prove

Every method we run, the limit it is judged against, and — the part usually left out — the question it does not answer. A test you misunderstand is worth about as much as a test nobody ran.

01 The required panel — peptides A record missing any of these is not a pass
Identity
LC-MS, ESI positive
Observed mass against theoretical, tolerance ± 1.0 Da
Proves: the material is the molecule named on the label.
Does not prove: how much of it is there, or that it is pure. Isomers can share an identical mass, which is why chromatography must run alongside.
required
Purity
RP-HPLC-UV at 214 nm, area normalisation
C18 column, gradient and retention time disclosed on every record
Specification ≥ 98.0 % area
Proves: what share of the detected material is the target compound.
Does not prove: how much peptide is in the vial. This is an area percent, not a weight. It is the single most misread number in the industry.
required
Net peptide content
Quantitative amino acid analysis
6 N HCl hydrolysis, 110 °C / 24 h
Specification ≥ 80 % of stated fill
Proves: how much actual peptide is in the vial by weight, once water, counterion and bulking agent are excluded.
Why it matters: a vial can be 99 % pure and 65 % peptide. This is the number that catches padding, and the one most often omitted.
required
Water content
Karl Fischer titration, coulometric
Specification ≤ 8.0 %
Proves: lyophilisation was done properly.
Why it matters: residual water shortens shelf life and inflates apparent fill weight.
required
Counterion content
Ion chromatography, suppressed conductivity
Specification ≤ 12.0 % TFA
Proves: how much trifluoroacetate is carried over from synthesis.
Why it matters: TFA is cytotoxic above threshold and is a large part of what makes up the gap between purity and content.
required
Residual solvents
Headspace GC-MS
ICH Q3C / USP <467> limits
Proves: synthesis and purification solvents were removed — acetonitrile, DMF, dichloromethane, ether.
Why it matters: several are toxic at low concentration and none belong in a finished product.
required
Bacterial endotoxin
Kinetic chromogenic LAL, USP <85>
Specification < 0.5 EU/mg
Proves: absence of pyrogenic bacterial cell-wall fragments.
Why it matters: endotoxin survives sterilisation. A sterile product can still cause a severe febrile reaction.
injectables
Sterility
Direct inoculation, USP <71>
14-day incubation
Proves: no viable organisms recovered over fourteen days.
Why it matters: it takes the full fourteen days. Any laboratory returning a sterility result in under two weeks did not perform this test.
injectables
02 Small molecules Different panel, same principle

Not everything sold alongside peptides is a peptide. Small molecules take a different required panel, and applying peptide logic to them — as we have seen done on certificates in circulation — produces documents that are wrong in ways nobody catches.

TestMethodSpecification
IdentityLC-MS against certified reference standardWithin ± 1.0 Da of theoretical
PurityRP-HPLC-UV at compound-appropriate wavelength≥ 95.0 % area
Assay / contentHPLC against certified reference standard≥ 90 % of stated content
Water contentKarl Fischer titration≤ 5.0 %
Residual solventsHeadspace GC-MSICH Q3C / USP <467>
03 How we obtain samples Stated on every record we publish

This is the part of a testing programme that is almost never disclosed, and it determines what the result is worth. The four methods are not equivalent and we label which one applies every time.

MethodWhat happensStrength
Witnessed drawOur officer draws units from the sealed lot at the filling siteStrongest — the supplier cannot select the unit
Random pullUnits selected at random from the sealed lot under a documented sampling planStrong
Retail purchaseWe buy the product anonymously through the ordinary sales channelStrong — the seller does not know it is being tested
Client-submittedThe client selects and sends the unitWeakest — certifies that vial only, and cannot speak for the lot
04 The rules we cannot be paid to bend Enforced by the system, not by policy
RULE 01

Everything gets published

If we test a lot, every result we produce for it appears on this site — pass or fail. A supplier cannot commission a test and bury the outcome. This rule is the only reason anyone has cause to believe the passes.

RULE 02

Incomplete is never a pass

A record missing any required test renders as INCOMPLETE and names what is missing. There is no configuration that turns a partial panel into a clean certificate.

RULE 03

Method or it did not happen

Every chromatographic result carries its wavelength, column, gradient and retention time. A figure nobody can reproduce is not evidence.

RULE 04

Records are bound to lots

No lot number, no record. A certificate that floats free of a batch will be used to sell everything the seller ever ships.

RULE 05

Records age in public

Issue date, age in days and retest date appear on every record. Results more than a year old are flagged as ageing rather than quietly reused.

RULE 06

We serve the record, not the seller

Records live on attest214.com. A supplier cannot edit one, and cannot remove a failure from one. An image on a shop's website is not a record.