We have a globally diverse tested and validated supply chain for our products.

By holding our supply chain partners to strict quality guidelines and contractual requirements, we reject (and they refund) any product that does not meet our standards.

Our raw materials partners are FDA audited, registered and inspected facilities manufacturing under stringent cGMP (current Good Manufacturing Practices) guidelines in the U.S., Taiwan and China.

For this industry, I think the smart play is to diversify the supply chain. For 3 specific reasons.

A peptide synthesized in California under cGMP and one synthesized under the same standards in Denmark or Taiwan or Hong Kong should be indistinguishable in quality. Conversely, a non-GMP “garage lab” in any country is a gamble. Our approach is to evaluate the supplier and its data -- not the flag on the label.

As part of our quality system, we monitor those partners FDA audits, looking for potential compliance issues which are filed under "inspectional observations" on Form FDA 483 or FDA Warning Letters, which are sent weeks–months after a 483 if FDA decides the firm’s response is inadequate or if the violations are especially serious.

At the date of this article being written, Saturday July 12th 2025, there have been no findings for our partners peptide API (actual pharmaceutical ingredient) since we started operations.

Peptidology works exclusively with highly regulated, FDA audited, ISO certified analytical labs located in the United States.

Industry standard is 2 analytical tests -- purity and quantity by HPLC (High Performance Liquid Chromatography). Some folks use Mass Spectrometry, which uses a different analysis to arrive at usually similar results.

Peptidolody standard is 5 analytical tests -- performed twice, once when we receive the raw materials. And when the finished product is completed production.

We go well beyond the standards with sterility, endotoxin and heavy metals testing.

Finished product -- Greater than 99% as verified by HPLC

Raw material - Greater than 99.5% as verified by HPLC

The sterile filtration (aseptic processing) we do can reduce purity levels slightly.

Endotoxins are natural toxins found in the outer wall of certain bacteria (called Gram-negative bacteria). They’re made of a fat-sugar molecule called lipopolysaccharide (LPS). When these bacteria grow or die, tiny bits of the wall can break off and get into surrounding fluids. If endotoxins reach the bloodstream or tissues in people or animals, they can trigger strong immune reactions such as fever, inflammation, or even dangerous septic shock. Because they’re invisible and heat-stable, medical products—especially those injected into the body—are carefully tested to be sure endotoxin levels stay extremely low.

Acceptable limits for endotoxins are complex, because the answer is truly -- "it depends".

Doctors have found that most people will start to feel feverish or sick from endotoxins in an IV drug if they receive more than about 5 endotoxin units (EU) for every kilogram (2.2 lb) of body weight within an hour. Medicines injected around the spinal cord are even more sensitive—so for those, the limit is about 0.2 EU per kilogram.

To put it simply, for Endotoxins, Peptidology products are aligned to the most stringent end of the USP <85> / EP 2.6.14 / JP 4.01 limits and, by extension, FDA’s guidance.

Peptidology products must never exceed Endotoxins higher than 0.05EU per mL.

Testing a peptide solution with the USP <71> sterility test is simply a way of proving that the product is completely free of any living germs that could influence the outcomes of your research.

Sterile = absolutely no bacteria, fungi, or other microorganisms alive in the product.

For heavy metals, the U.S. does establish procedures and limits for "Elemental impurities". To simplify a complex standard, we are working with our analytical lab to develop a pass/fail test for 6 different heavy metals, such as Chromium, Arsenic, Cadmium, Lead, Aluminum, and Mercury. Not all of our products have heavy metals testing. We are working to have heavy metals testing in our entire product portfolio by the end of 2025.

Today we work with contract manufacturers (the folks who produce the finished products) in the U.S., Taiwan and China. Our roadmap includes acquiring or building a GMP-certified finishing facility in the United States that we control.

For lyophilized peptides, we specify aseptic processing by way of 0.22 µm sterile-filtered product, produced in GMP-compliant or certified facilities, before they are freeze dried. We verify sterility by performing USP <71> sterility testing a sample.

Industry standard is 2 analytical tests. Peptidolody standard is 5 analytical tests.

We go well beyond the standards with sterility, endotoxin and heavy metals testing.

Finished products are labeled batch-coded with QR codes to Certificates of Analysis and expiration dates. Quality and consistency is tracked and assured.

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