Pralmorelin API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Pralmorelin API Manufacturer in India

Pralmorelin, also known as GHRP-2 (Growth Hormone-Releasing Peptide-2) and KP-102, is a synthetic hexapeptide that acts as a growth hormone secretagogue. The peptide consists of the sequence D-Ala-D-2-Nal-Ala-Trp-D-Phe-Lys-NH₂ and has the molecular formula C₄₅H₅₅N₉O₆ with an active-moiety molecular weight of approximately 817.98 g/mol.

For pharmaceutical use, Pralmorelin is associated with its hydrochloride salt form, specifically Pralmorelin Dihydrochloride, CAS 158827-34-0, with a molecular weight of approximately 890.90 g/mol. The Japanese JAN database lists Pralmorelin Hydrochloride as the dihydrochloride salt, while Japan's PMDA approved Pralmorelin Hydrochloride (GHRP Kaken 100) as a diagnostic agent for examination of growth-hormone secretory function.

API Overview

Pralmorelin is a synthetic peptide and agonist of the growth hormone secretagogue receptor (GHSR). It stimulates growth hormone secretion and has been used clinically in Japan as a diagnostic agent for evaluating growth hormone secretory function. PMDA records Pralmorelin Hydrochloride as an approved diagnostic ingredient, while KEGG classifies it as an endocrine-function diagnostic agent.

Unlike conventional small-molecule APIs, Pralmorelin requires peptide-specific quality controls. Identity confirmation may include chromatographic analysis, mass spectrometry and other structural characterization techniques. Peptide purity is commonly evaluated using reversed-phase HPLC, while molecular identity can be confirmed by mass spectrometry.

Chemical and Pharmaceutical Profile

Pralmorelin is a six-amino-acid synthetic peptide containing both D- and L-configured residues. The active peptide has the condensed sequence H-D-Ala-D-2-Nal-Ala-Trp-D-Phe-Lys-NH₂. PubChem and FDA GSRS identify Pralmorelin under CAS 158861-67-7, while the dihydrochloride pharmaceutical salt has CAS 158827-34-0.

The hydrochloride form has the composition C₄₅H₅₅N₉O₆·2HCl and molecular weight 890.90 g/mol.

Pharmaceutical Applications

Pralmorelin Hydrochloride has an established diagnostic application in Japan for assessment of growth hormone secretory function. PMDA documentation lists GHRP Kaken 100 for Injection as a diagnostic product containing Pralmorelin Hydrochloride.

Scientific literature also describes GHRP-2 as a potent growth hormone-releasing peptide and identifies Pralmorelin Hydrochloride as its generic pharmaceutical name.

Quality and Analytical Testing

Because Pralmorelin is a peptide API, conventional small-molecule tests such as melting point and residue on ignition are not necessarily the most meaningful universal release criteria. More appropriate controls include peptide identity, chromatographic purity, molecular-mass confirmation, water/moisture, residual solvents and, where relevant, microbial and endotoxin testing.

Commercial peptide analytical references commonly report ≥98% HPLC purity, but these are commercial/research specifications and should not be represented as a pharmacopoeial Pralmorelin release limit.

Pralmorelin API Manufacturer in India

A pharmaceutical API manufacturing program for Pralmorelin should control peptide synthesis, purification, salt formation, lyophilization and packaging under appropriate quality systems. Batch-specific analytical documentation should establish identity, purity and consistency of the peptide material.

For customers requiring pharmaceutical-grade peptide API documentation, appropriate records may include a Certificate of Analysis, analytical methods, batch results, residual-solvent information, elemental impurity assessment, stability information and other regulatory documentation applicable to the intended market.

Packaging and Storage

Pralmorelin peptide material is generally handled as a lyophilized powder and should be protected from moisture and excessive temperature. Research-grade peptide references commonly recommend refrigerated or frozen, desiccated storage; the exact storage condition for a pharmaceutical API should follow the validated stability program and approved product specification.

Documentation

Typical documentation can include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • HPLC purity report
  • Mass spectrometry identity report
  • Water/moisture result
  • Residual-solvent report
  • Elemental impurity assessment
  • Stability information
  • SDS
  • Batch manufacturing and quality documentation

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Get Bulk Quote via WhatsApp