Microbial limits (bioburden)
USP <61> enumerates microbial load; USP <62> evaluates specified microorganisms under the stated test conditions.
QBio · Quality
Everything a compliance officer would ask,
answered before you ask.
Compliance anxiety is the quiet objection in this category. Rather than wait for the diligence email, we have put the answers — including the uncomfortable ones — on a public page.
Lot-level documentation
Find a certificate of analysis
Enter the lot number exactly as it appears on the vial or package.
Release testing
Three tests. Every batch.
USP <61>, USP <62>, and USP <85> are performed by an independent laboratory on every batch. Results are recorded on that lot’s certificate of analysis.
Bacterial endotoxins
A compendial test used to evaluate bacterial endotoxin against the release specification for the lot.
Third-party, not in-house
Testing is performed by an independent laboratory on every batch, and the results are recorded on that lot’s certificate of analysis.
Regulatory position
What QBio is — and what it isn’t.
In plain language, without the hedging this category is known for.
What it is
- An acellular, cell-free topical cosmetic
- For professional use, on a single patient
- Manufactured in an FDA-registered facility in Irving, Texas
- Characterized by independent university laboratories
- Accompanied by a certificate of analysis for every lot
What it is not
- A drug, a biologic, or an approved therapy
- Intended to diagnose, treat, cure or prevent any condition
- Intended for injection or intravenous delivery
- FDA approved — no exosome product is
- Sold to consumers on this site
Are exosomes FDA approved?
No. There are no FDA-approved exosome products, for any indication, from any company. Any supplier telling you otherwise is either mistaken or misleading you. QBio products are topical cosmetics for professional use — not drugs, not biologics, and not approved therapies.
What does “FDA-registered facility” actually mean?
It means the manufacturing establishment is registered with the FDA. It is a registration, not an approval, and it says nothing about whether any particular product has been reviewed or cleared. We state it because it is true and relevant to how the product is made — not as a substitute for approval we do not have.
Can QBio be injected?
No. QBio products are for topical use only. They are not intended for injection or intravenous delivery, and we do not supply them for that purpose. This is stated on the product, in the Application Procedure and in the footer of every page on this site.
What claims does QBio make?
Appearance-based cosmetic claims only. We describe how the product is used and what is measurably in it. Where we discuss biology, we are describing published literature about ingredients — not asserting what the finished product does to anyone. We do not make therapeutic claims, and we ask our providers not to make them on our behalf.
Is the product tested for safety?
Every batch undergoes third-party microbial limits testing to USP <61> and USP <62>, and bacterial endotoxin testing to USP <85>. Results are recorded on the lot certificate of analysis, which you can look up by lot number on this page.
Responsible claims
How we talk about this product.
We hold ourselves to three rules, and we would rather lose a sale than break them.
Appearance-based cosmetic claims only.
We describe how something looks, not what it does biologically to a person.
Measured composition stays measured.
We publish the analytical identity, concentration, method, and laboratory reported in the characterization documentation.
No therapeutic claims, ever.
Not in our copy, not in our sales conversations, and — we ask — not in yours. Our Case Submission Kit includes a brand usage sheet covering what not to say, because a provider making a drug claim about our product is our problem too.
Ethical sourcing
What is not in the vial matters.
Our sourcing page publishes the donor-eligibility review and infectious-disease screening panel behind qualified perinatal-tissue inputs.
Document library
Trust should be downloadable.
Public documents remain public. Commercial documents are provided through the professional conversation.
PublicComposition summaries
Full quantified protein tables for Elixir and Gro, with the third-party laboratories named.
Open the data →PublicPre-clinical studyComplete in vitro methods, results and references, organized for direct professional review.
Read the study →PublicLot certificatesMicrobial limits and endotoxin results, searchable by lot number.
COA lookup →On requestRegulatory position memoOur counsel-reviewed position, for your compliance file.
Request it →On requestFull evidence dossierEverything above in one forwardable document. No pricing in it.
Request the dossier →With your orderStandard Application ProceduresStep-by-step reconstitution and application, per product.
See the protocols →