CBN
CBN API status, reference standards, and what a USP impurity limit is not
CBN is the oxidation product of THC rather than something a synthase makes. It has no approved drug behind it and no monograph of its own — the one place it appears in pharmacopoeial work is inside USP's still-draft CBD monograph, as an impurity limit, which is a very different thing from being a standard. Peregrine supplies research-grade CBN isolate at ≥99.9% today, and is direct that this is a research-isolate bar rather than an API bar.
- Cannabinol
- CAS 521-35-7 · C21H26O2 · 310.43 g/mol
- API status
- No approved drug uses CBN. Today's material does not yet meet API purity.
- Standard status
- No monograph of its own. Appears in USP's draft CBD monograph as an impurity limit.
- What Peregrine sells today
- Research-grade isolate, ≥99.9%, 5 g to 100 kg, COA per lot. Water-dispersible powder separately.
Can I buy CBN as an API today?
No. There is no approved drug whose active ingredient is CBN, which is the condition the word describes. The manufacturing obligations that follow an API — ICH Q7 GMP, ICH Q3A impurity qualification, ICH Q1A stability, a referenceable Drug Master File — exist because a drug filing exists. For CBN, none does.
A headline purity figure and an API are not the same bar. An API is judged on its characterised impurity profile, not only on how high the assay reads. Today Peregrine's CBN does not yet reach the purity that API status requires, and the company is working to make that happen. It is engineering in progress, not a plan on a slide.
Where do I buy a CBN standard?
In milligrams, from a reference-material producer, with a certificate for the vial. The producer accreditation is ISO 17034; the testing-laboratory one is ISO/IEC 17025.
Cayman, Cerilliant, Supelco, Restek and LGC all list CBN. A 10 mg vial is the usual unit.
CBN is the one compound here with any pharmacopoeial presence, and it is worth being precise about what that presence is: USP's draft monograph for cannabidiol sets a limit on CBN as an impurity. A limit inside someone else's monograph is not a monograph, and it is not a reference standard.
What does GMP CBN actually mean?
Whichever of the four regimes the supplier means. ICH Q7 is written for active pharmaceutical ingredients; 21 CFR 210/211 for finished drug products; 21 CFR 111 for dietary supplements; ISO 22716 for cosmetics. Several suppliers in this market advertise GMP on the strength of NSF/ANSI 455-2, which is the supplement standard.
What does pharma grade CBN mean?
It is not a defined term. For CBN there is no monograph to meet, so the phrase has nothing to anchor to. The assay basis and the identity method are the things worth asking for.
What can Peregrine supply now?
Research-grade CBN isolate at ≥99.9%, from 5 g to 100 kg, with identity by HPLC and assay as % w/w on the lot COA. There is also a water-dispersible CBN powder, which is reported as cannabinoid-in-powder rather than as an isolate assay — the number on that COA describes the powder you receive, not the isolate that went into it.
Peregrine is working to supply all of it — API-grade material, certified standards and GMP-declared volume — at research and industrial scale worldwide, through its own patented synthesis process.
Buying CBN
Where do I buy CBN API?
No supplier has a CBN API, Peregrine included. A headline purity figure and an API are not the same bar. An API is judged on its characterised impurity profile, not only on how high the assay reads. Today Peregrine's CBN does not yet reach the purity that API status requires, and the company is working to make that happen. It is engineering in progress, not a plan on a slide.
CBN's position in pharmacopoeial work is unusual enough to state plainly: it appears in USP's draft CBD monograph as an impurity limit, which means the compendia have written about CBN mainly as something to keep out of something else. A monograph of its own is a different piece of work, and it follows supply rather than preceding it.
Who has bulk CBN API?
Nobody. Bulk CBN at research grade is a different matter — Peregrine ships isolate from 5 g to 100 kg, and a water-dispersible powder separately for beverage and gummy work, which is a different product with a different assay basis rather than a cheaper isolate.
Sleep-category formulators ask for CBN more than for anything else in this catalogue. The material is sold as an ingredient with no claim attached, and a supplier who offers you one alongside the quote is telling you something about how they read the regulations.
Is a sample CBN API quantity available?
Ask for the 5 g research cut. It ships with the lot certificate to a named facility, drawn from the same lot as any larger order.
Ask for the residual Δ9-THC figure specifically. CBN forms by oxidation of THC, so the starting material's history matters more here than it does for a synthase product, and the number on the certificate is the one your destination's regulator will care about.
Who manufactures CBN API?
No one holds API status, and CBN is the compound where the manufacturing route matters most. CBN forms when THC oxidises, so one way to make it is to start from THC and let that happen. The other is to synthesise it. The first route is cheaper and brings the obvious passenger: residual THC, which turns a shipment into a controlled substance problem and a certificate line into the most important number on the page.
Ask every CBN supplier which route made the lot in front of you, and ask what the THC figure is by a method that can actually see it at that level. A supplier who answers both without hesitating has told you more about their operation than any certificate would.
Questions
What does it mean when you find CBN API advertised?
Usually that the seller holds a dietary-supplement GMP certificate and considers the material pharmaceutical quality. Both halves can be true and neither makes it an API. CBN has no approved drug behind it, and its only appearance in pharmacopoeial work so far is as an impurity limit inside USP's draft CBD monograph.
Is CBN an active pharmaceutical ingredient?
Not today. No approved drug uses CBN as its active ingredient, and Peregrine's current material does not reach the purity an API requires. That work is under way.
Is there a USP standard for CBN?
No. CBN appears in USP's draft cannabidiol monograph as an impurity limit, not as a monograph or reference standard of its own. Certified material comes from commercial reference-material producers.
Can Peregrine supply a CBN sample?
Yes. The 5 g research cut is the sample size, shipped to a named facility with the lot COA.
Do you sell bulk CBN?
Yes, from 5 g to 100 kg. A water-dispersible CBN powder is a separate product with its own assay basis.
Is CBN made by the plant?
Not directly. CBN is what THC becomes through oxidation over time, rather than a product of one of the three synthases.
How do I choose a CBN API supplier?
No. CBN isolate is widely available and Peregrine ships 5 g to 100 kg, but API status does not exist for it. For CBN the route matters more than the grade: material made by oxidising THC carries residual THC, so ask which route made the lot in front of you and what the THC figure is by a method that can see it at that level.
Sources
- 21 CFR 210.3(b)(7)FDA's definition of an active ingredient
- ICH Q7Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 4, 2000
- ICH Q3A(R2)Impurities in New Drug Substances, Step 4, 2006
- ISO 17034General requirements for the competence of reference material producers (paywalled)
- NSF/ANSI 455-2Good Manufacturing Practices for dietary supplements (paywalled)
Related: What CBN isHow to read a COAQuestions to ask a supplierQuality methods
The vocabulary
- What is an API (active pharmaceutical ingredient)?The regulatory definition, the five things it actually requires, and why a purity figure is not one of them.
- API grade vs research grade: what actually changesThe molecule is the same. What differs is how much of its history is documented, and who answers for it.
- Where do I buy a cannabinoid reference standard?Who actually sells them, what the certificate must say, and why ISO 17034 and 17025 are not interchangeable.
- GMP ingredients: which GMP, and what each one coversFour unrelated regimes share the word. Which certificate means what, and the three questions that settle a claim.
- What does pharma grade mean?An empty phrase doing a real job badly — and the five-line specification that replaces it.
- How do you qualify a cannabinoid API supplier?Directory listings promise DMF and CEP against compounds that can hold neither. The questions that separate a manufacturer from a broker.
Other compounds
- CBGNo approved drug uses CBG, no USP standard exists, and what GMP CBG usually means.
- CBGAThe precursor acid: no monograph, no drug programme, and what its stability question is.
- CBGVThe varin branch precursor: scarce, campaign-based, no monograph.
- CBDVThe one with real clinical history — and what missing an endpoint does and does not change.
- THCVWhere today's purity falls short of an API bar, stated plainly.
- Cannflavin AA prenylated flavone, not a cannabinoid: preclinical, milligram-scale, no bulk supply anywhere.