What Grade Bio is
A short list, made repeatedly, is how a compounding operation earns a reputation. The register is the whole of it. Nothing joins it because a molecule is in the news, and nothing stays on it that cannot be released against a written specification.
Every entry carries the identifiers a pharmacist or a prescriber uses to check us: the registry number, the molecular formula, the mass, the assay floor the material is held to, and the presentation it is filled in. Those five figures are printed in the same order on the release document, and they are the same five held in the retention record. There is one set of numbers in this company.
An entry leaves the register the same way it joined it, in writing. When hydroxocobalamin was withdrawn in February its row stayed on the register, marked, so that an account holding an older lot can still reach the paperwork behind it.
The register
This is a register, not a catalog of offers. It shows the product and it does not sell it. Two entries are held on revision and are shown that way; one entry was withdrawn in February and its row was kept so a prior lot stays traceable.
Every specimen below links to the sheet behind it. Where a sheet has not been issued yet, the row says so rather than borrowing the sheet next to it. A row without a sheet number is not a finished entry.










| No. | Compound | CAS | Formula | Mass | Assay | Presentation | State |
|---|---|---|---|---|---|---|---|
| 01 | Sermorelin | 86168-78-7 | C149H246N44O42S | 3357.9 | ≥ 98.0 % | Lyophilized, 5 mg | Current |
| 02 | Thymosin alpha‑1 | 62304-98-7 | C129H215N33O55 | 3108.3 | ≥ 98.0 % | Lyophilized, 5 mg | Current |
| 05 | Glutathione, reduced | 70-18-8 | C10H17N3O6S | 307.32 | ≥ 99.0 % | Solution, 200 mg/mL | Current |
| 10 | Methylcobalamin | 13422-55-4 | C63H91CoN13O14P | 1344.4 | ≥ 98.5 % | Solution, 1 mg/mL | Current |
| 09 | Ascorbic acid | 50-81-7 | C6H8O6 | 176.12 | ≥ 99.0 % | Solution, 500 mg/mL | Current |
How a lot is released
Incoming material is identified before it is opened
Every container is checked against its certificate on arrival and held in quarantine until identity is confirmed in the building. A supplier's paper is a claim, not a result.
Appearance
Quarantine hold
Compounding runs against a written specification
The specification is fixed before the batch record is opened, and the record is signed at each step by the compounder and a second person. Nothing is reconstructed afterwards.
Two signatures
In‑process checks
The filled lot is assayed, inside and outside
Assay, water content and related substances are run by HPLC, then confirmed by an independent laboratory. Two results that disagree stop the lot.
Karl Fischer
Second laboratory
The document is issued with the lot, not after it
The release document carries the lot number, the figures behind it, the analyst and the date. A retention sample from the same fill is held for twenty four months.
Retention sample
24 month hold
How the material reaches a patient
Documents on file
| Form | Document | Issued | Held for | Pages |
|---|---|---|---|---|
| GB‑101 | Certificate of analysis | Every lot, at release | Life of the account | 2 |
| GB‑104 | Product specification | Per entry, on revision | Current and prior revision | 3 |
| GB‑110 | Safety data sheet | Per entry, on revision | Current revision | 8 |
| GB‑118 | Analytical method summary | On request, per entry | Current revision | 4 |
| GB‑140 | Retention sample record | Every lot, at fill | 24 months from fill | 1 |
Where to start
Read the register
Twelve entries, filed by class, with the identifiers behind each one and the state it is held in.
Sheet G‑02Ask a question
A clinic, a pharmacy, a supplier or the press. The contact sheet never asks for a license.
Sheet G‑09Request access
Verification for a licensed practitioner or an institution. It opens a pending record, never an active account.
Sheet G‑10Grade Bio is a brand of Mountain Brands LLC. Entity formation is pending and no registration has been filed. Correspondence to jv@gradebio.com or sw@gradebio.com.
Pre‑launch document Entity pending

