GradeBio Sheet G‑03.02  /  Thymosin alpha-1, specification G‑03.02Rev. A
GradeBio Entry 02 · specification
Sheet G‑03.02
Revision A  ·  01 Sep 2026

Thymosin alpha‑1.
Twenty‑eight residues,
N‑terminally acetylated.

Thymalfasin is the pharmacopeial name for thymosin alpha‑1, an acetylated twenty‑eight residue peptide supplied as a sterile lyophilized cake, 5 mg to the vial, sealed under an inert headspace.

The N‑terminal acetyl group is part of the identity, not a detail: it is what a mapping method is checking for against a des‑acetyl impurity carrying the same residue count.

CAS
62304-98-7
Molecular formula
C129H215N33O55
Average mass
3108.3 g/mol
Presentation
Lyophilized, 5 mg
Assay floor
≥ 98.0 %
Label class
P  ·  physician use, prescription
Sequence  Thymalfasin, N-terminally acetylated 28-residue peptide
Thymosin alpha-1, a white to off-white lyophilized cake in a sealed glass vial.
Plate 1   Entry 02 as filled. A 5 mg cake, sealed, specimen photography.

Grade Bio  /  Register  /  Entry 02  /  Sheet G‑03.02

1.0

What this is

Identity and presentation

Thymosin alpha‑1 is registered here under its own entry, distinct from the wider thymosin peptide family: one sequence, one acetylation state, one CAS number.

It arrives as a white to off-white lyophilized cake, filled at 5 mg and sealed. The molecular formula and the average mass are the two figures the identity test is run against.

Class P labelThe vial and its carton carry FOR PHYSICIAN USE ONLY Rx ONLY and the prescription legend. No pharmacy name is printed on the label: dispensing runs through more than one licensed partner, and the pharmacy of record is disclosed at the point of dispensing, not printed in advance.
Not on this sheetNo dose, no schedule, no route, no protocol and no preparation direction. Those are clinical decisions and they belong to the prescriber and the dispensing pharmacist, not to the company that made the material.
2.0

Specification

Released against the figures below, lot by lot

Every attribute below is checked against a fixed specification before a lot is released. The result column shows specimen lot L‑24309. A lot that misses a line is not released, and the register entry is marked rather than the sheet edited.

AttributeMethodSpecificationResult
AppearanceVisualWhite to off-white lyophilized cakeConforms
Identity, massMass confirmation3108.3 g/mol (average)Conforms
Assay, purityRP‑HPLC≥ 98.0 %Conforms
PresentationGravimetricLyophilized, 5 mgConforms
Table 2.1   Thymosin alpha-1 · specification and specimen result, lot L‑24309.
3.0

Storage and retention

How it is held
Storage
− 20 °C
Light
Protect from light
In use
2 to 8 °C once reconstituted
Container
2 mL vial (ISO 8362-1, 2R)
Retained sampleA sample of every lot is held under the storage condition above, so a question can be answered from the material itself rather than from memory.
4.0

Documents behind this lot

What an account can pull
DocumentNo.What it shows
Certificate of analysisGB‑101Every attribute in table 2.1, the method, the specification and the measured result, signed on release.
Identity data packageGB‑104The reference data the lot's identity was confirmed against.
Method summaryGB‑110The analytical methods named in table 2.1, with their validation state.
Stability summaryGB‑118The data the storage condition rests on.
Lot genealogyGB‑140Raw material lot, fill date, container closure lot, and the release signature.
Table 4.1   A verified account can pull these against any lot it holds.
5.0

How it reaches a patient

The pharmacy of record does the dispensing

Grade Bio does not dispense and does not ship to a patient. Material is supplied only pursuant to a valid prescription for an individually identified patient, and it is dispensed by the licensed pharmacy of record named on the account. The practitioner writes the prescription. The pharmacy fills it. We supply the material and the paperwork that proves what it is. Sheet G‑07 sets out the whole route.

GradeBio

Grade 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

The register

The company