GradeBio Sheet G‑03.03  /  Ipamorelin, specification G‑03.03Rev. A
GradeBio Entry 03 · specification
Sheet G‑03.03
Revision A  ·  01 Sep 2026

Ipamorelin.
Five residues,
amidated, on revision.

Ipamorelin is a synthetic pentapeptide, Aib-His-D-2-Nal-D-Phe-Lys-NH₂, pentapeptide, supplied as a sterile lyophilized cake, 5 mg to the vial.

This entry is filed as a reference material and carries no prescription legend. It is marked on revision; section 5.0 states why.

CAS
170851-70-4
Molecular formula
C38H49N9O5
Average mass
711.85 g/mol
Presentation
Lyophilized, 5 mg
Assay floor
≥ 98.0 %
Label class
M  ·  reference material
Sequence  Aib-His-D-2-Nal-D-Phe-Lys-NH₂, pentapeptide
Ipamorelin, a white lyophilized solid in a sealed glass vial.
Plate 1   Entry 03 as filled. A 5 mg cake, sealed, specimen photography.

Grade Bio  /  Register  /  Entry 03  /  Sheet G‑03.03

1.0

What this is

Identity and presentation

The sequence above is the identity: five residues, including two non‑proteinogenic ones, and a C‑terminal amide.

It is filled at 5 mg, sealed, as a white lyophilized solid. The molecular formula and the average mass are the figures the identity test is run against.

Class M labelThe vial and its carton carry REFERENCE MATERIAL — SPECIFICATION LABEL and a handling caution: “Handle under an institutional chemical hygiene plan. Avoid raising dust. Keep the container closed.” No physician‑use language, no Rx legend and no pharmacy routing appear on this class of label.
Not on this sheetNo dose, no schedule, no route, no protocol and no preparation direction. Those are clinical decisions and this entry is not filed for clinical use.
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 lyophilized solidConforms
Identity, massMass confirmation711.85 g/mol (average)Conforms
Assay, purityRP‑HPLC≥ 98.0 %Conforms
PresentationGravimetricLyophilized, 5 mgConforms
Table 2.1   Ipamorelin · 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 in solution
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

Regulatory status

Why this entry is marked on revision

This entry sits in the group an FDA advisory committee discussed for the 503A bulk substances list in July 2026. That recommendation is advisory. A proposed rule and then a final rule would be required, and neither has issued. Nothing in that group is compoundable today, so this entry is marked on revision and is not available. No date is stated or implied. Sheet G‑02 carries the full register entry.

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