Sermorelin is a synthetic peptide corresponding to the amino-terminal 29-amino-acid portion of human growth hormone-releasing hormone (GHRH). It is also known as GHRH(1-29) amide, GRF(1-29)NH2 and growth hormone-releasing factor (human)-(1-29)-peptide amide. Sermorelin is an amidated peptide designed to reproduce the biologically active N-terminal portion of human GHRH.
The active Sermorelin peptide is identified by CAS Number 86168-78-7 and has an average molecular weight of approximately 3357.9 Da. Pharmaceutical Sermorelin has historically been supplied as Sermorelin Acetate, which has the separate CAS Number 114466-38-5. FDA GSRS recognizes Sermorelin as the active moiety and Sermorelin Acetate as its acetate salt form.
Sermorelin consists of 29 amino acids and has the sequence H-YADAIFTNSYRKVLGQLSARKLLQDIMSR-NH2. The C-terminal amidation is an important structural characteristic of the biologically active peptide. Unlike full-length human GHRH, which contains 44 amino acids, Sermorelin represents the biologically active N-terminal fragment.
As a synthetic peptide, Sermorelin requires peptide-specific analytical characterization. Chemical identity can be established using mass spectrometry and chromatographic techniques, while peptide purity and related peptide impurities are commonly evaluated by validated chromatographic methods.
Sermorelin has the molecular formula C149H246N44O42S and an average molecular weight of approximately 3357.9 Da. The molecule contains numerous charged and polar amino-acid residues, resulting in physicochemical characteristics substantially different from conventional small-molecule pharmaceutical APIs.
Sermorelin Acetate is the acetate salt form associated with the pharmaceutical development of the peptide. FDA GSRS lists Sermorelin Acetate under CAS 114466-38-5 and describes it as the acetate salt/hydrate form of the synthetic 29-amino-acid peptide.
Sermorelin acts as a growth hormone-releasing hormone analogue and stimulates the pituitary pathway responsible for endogenous growth hormone release. Historically, Sermorelin Acetate was developed as a diagnostic and therapeutic peptide for growth hormone deficiency in children with growth failure.
The U.S. FDA approved Sermorelin Acetate under the trade name Geref in 1997 for an orphan indication involving idiopathic or organic growth hormone deficiency in children with growth failure. The historical FDA record should be treated as regulatory history rather than evidence of a currently marketed U.S. product.
Sermorelin is a peptide API, so conventional small-molecule specifications such as melting point, residue on ignition and simple percentage assay should not be automatically applied. Appropriate quality testing focuses on peptide identity, molecular mass, chromatographic purity, related peptides, residual process impurities, water content where applicable and biological activity.
Mass spectrometry is particularly useful for confirming the expected molecular mass, while RP-HPLC or another validated peptide chromatographic method can be used for purity and related-substance characterization. A batch-specific Certificate of Analysis should clearly identify whether purity is reported by HPLC area percentage, peptide content or another validated analytical basis.
Sermorelin intended for pharmaceutical or regulated peptide manufacturing should be produced using controlled peptide-synthesis and purification processes. Important manufacturing controls include starting-material quality, coupling efficiency, deprotection, cleavage, purification, peptide-related impurities and final molecular identity.
A suitable technical package may include Certificate of Analysis, peptide identity, mass-spectrometry data, chromatographic purity, related-peptide profile, water content, residual-solvent data and stability information as applicable.
Sermorelin is a synthetic peptide and should be protected from environmental conditions that can promote peptide degradation. Appropriate packaging and storage conditions should be established from validated stability data for the specific peptide form and formulation.
For a peptide API, the manufacturer should distinguish between the storage requirement of the bulk drug substance and that of the final sterile or lyophilized pharmaceutical formulation.
Sermorelin API documentation can include a Certificate of Analysis, specification sheet, peptide sequence confirmation, LC-MS or mass-spectrometry identity, HPLC purity, related-peptide profile, residual-solvent information, water-content data, stability information and applicable GMP documentation.
Sermorelin is a well-characterized synthetic 29-amino-acid GHRH fragment with a defined peptide sequence and established pharmaceutical development history. Its quality assessment requires specialized peptide analytical methods capable of confirming molecular identity, purity and related-peptide characteristics. Correct identification of Sermorelin versus Sermorelin Acetate is particularly important when preparing pharmaceutical API documentation and specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | ≥99% |