GradeBio Sheet G‑03.01  /  Sermorelin, specification G‑03.01Rev. A
GradeBio Entry 01 · specification
Sheet G‑03.01
Revision A  ·  31 Aug 2026

Sermorelin.
Twenty‑nine residues,
checked twice.

A 29 residue peptide amide, the 1 to 29 fragment of human growth hormone releasing hormone. Supplied as a sterile lyophilized cake, 5 mg to the vial, sealed under an inert headspace.

The mass is confirmed by electrospray and the sequence by peptide mapping, because a mass on its own can be met by more than one arrangement of the same residues. Both results sit on the certificate.

CAS
86168-78-7
Molecular formula
C149H246N44O42S
Average mass
3357.9 g/mol
Residues
29, C‑terminal amide
Assay floor
≥ 98.0 % by RP‑HPLC
Presentation
Lyophilized, 5 mg per vial
Label class
P  ·  physician use, prescription
Sequence  Tyr‑Ala‑Asp‑Ala‑Ile‑Phe‑Thr‑Asn‑Ser‑Tyr‑Arg‑Lys‑Val‑Leu‑Gly‑Gln‑Leu‑Ser‑Ala‑Arg‑Lys‑Leu‑Leu‑Gln‑Asp‑Ile‑Met‑Ser‑Arg‑NH2
Sermorelin, a white lyophilized cake in a sealed glass vial.
Plate 1   Entry 01 as filled. A 5 mg cake, sealed, specimen photography.

Grade Bio  /  Register  /  Entry 01  /  Sheet G‑03.01

1.0

What this is

Identity and presentation

Sermorelin is the 1 to 29 amide fragment of human growth hormone releasing hormone: a twenty nine residue peptide with a free amino terminus and an amidated carboxy terminus.

It arrives as a white lyophilized cake, filled at 5 mg and sealed. What makes a peptide hard is not making it once; it is making it the same way in October that you made it in March. That is what the identity package on this sheet is for.

The C terminal amide is part of the identity, not a detail. A free acid at position 29 is a different molecule with the same residue list, and the mapping method distinguishes them.

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 has a method behind it and a number the lot has to reach before it leaves. The result column shows specimen lot L‑24309. A lot that misses a single line is not released, and the register entry is marked rather than the sheet edited.

AttributeMethodSpecificationResult
AppearanceVisualWhite to off‑white cakeConforms
Identity, massESI‑MS3357.9 ± 2.0 Da3357.6 Da
Identity, sequenceLC‑MS/MS peptide mapConforms to referenceConforms
Assay, purityRP‑HPLC, area %≥ 98.0 %99.1 %
Single largest impurityRP‑HPLC, area %≤ 1.0 %0.4 %
Peptide contentNitrogen determination≥ 80.0 %84.2 %
Water contentKarl Fischer≤ 6.0 %2.8 %
Acetate contentIon chromatography≤ 12.0 %7.9 %
Residual solventsHeadspace GCPer ICH Q3CConforms
Clarity of solutionVisual, method GB‑QM‑014Clear, no visible particulateConforms
Bacterial endotoxinLAL, kinetic chromogenic≤ 10 EU/mg< 1.0 EU/mg
SterilityMembrane filtration, 14 daySterileSterile
Container closure integrityDye ingressNo ingressConforms
Net cake massGravimetric5.0 mg ± 5 %5.02 mg
Table 2.1   Sermorelin · specification and specimen result, lot L‑24309.
3.0

Storage and retention

How it is held, and how long the paperwork lives
Storage
−20 °C, sealed
Light
Protect from light
Retest period
24 months from release
Retained sample
24 months, same condition
Container
Type I glass, elastomeric closure, aluminium seal
Retained sampleA sample of every lot is held under the storage condition above for the full retention period, so a question asked in month twenty two can be answered from the material itself rather than from memory.
Why the cake is kept coldA lyophilized peptide is stable because it is dry. The retest period rests on stability data held at the storage condition above, and the summary is on file as GB‑118.
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‑104Electrospray mass spectrum, the annotated peptide map and the reference chromatogram the lot was compared against.
Method summaryGB‑110The analytical methods named in table 2.1, with their validation state.
Stability summaryGB‑118The data the storage condition and the retest period rest on.
Lot genealogyGB‑140Raw material lot, fill date, container closure lot, and the release signature.
Table 4.1   A verified account can pull all five 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