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Laboratory standards

What we test, the limits a lot has to meet before it is listed, and what happens when it doesn't.

Every lot, four tests

No lot is listed for sale until an independent analytical laboratory has returned results on all four of the panels below. Testing is paid for by us but performed and reported by the laboratory, and we publish the report as issued.

Purity by RP-HPLC

Reverse-phase HPLC with UV detection at 220 nm. Main-peak area is reported as a percentage of total peak area.

Release limit: ≥ 98.0 %

Identity by LC-MS

Electrospray mass spectrometry. The deconvoluted mass must agree with the theoretical molecular weight of the sequence.

Release limit: within ± 1.0 Da

Net peptide content

Quantitative amino-acid analysis or UV absorbance against a reference standard, reported in mg per vial.

Release limit: ≥ 95 % of label claim

Bacterial endotoxin

Kinetic LAL assay per USP <85> on a reconstituted sample.

Release limit: < 1.0 EU/mg

Sampling

Samples are pulled from sealed finished vials, not from bulk powder, so the report describes what ships. For lots above 500 vials, two vials from different fill positions are tested and the lower result is reported.

When a lot fails

A lot that misses any release limit is rejected and returned to the manufacturer. We do not re-test a failed lot in search of a passing result, and we do not relabel it at a lower nominal content.

Storage and chain of custody

Finished vials are received on dry ice, logged by lot, and held at −20 °C in monitored freezers until the day they ship. Freezer logs are kept for three years and are available on request for any lot number.

Reference standards

Where a certified reference standard exists for a compound, the testing laboratory uses it for identity and content assays. For novel compounds without a commercial standard, identity relies on mass spectrometry and, where available, amino-acid sequencing.

What the COA does not tell you. A certificate of analysis describes a sample from a lot on the day it was tested. It is not a guarantee of stability after shipment, nor a statement about biological activity. Store vials as directed and run your own analyses where your protocol requires it.

Partner laboratories

We work with ISO/IEC 17025-accredited contract laboratories in the United States. Each report names the laboratory that issued it. We do not operate an in-house lab and never test our own product.

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