WHO-GMP Certified Commercial Pack · Product Code: AKP-API-01
Leuprorelin Acetate Peptide API
Peptide API Overview: GnRH agonist decapeptide API for sustained pituitary desensitization and androgen/estrogen suppression depot formulations. Indicated for Prostate cancer, Breast cancer. Supplied as lyophilized crystalline powder (Purity ≥ 99.0% HPLC, CAS 74381-53-6) with Certificate of Analysis (HPLC/MS), stability validation, and export technical dossier. Supplied as Lyophilized Peptide API (Purity ≥ 99.0% (HPLC)) within Pharmaceutical Peptide APIs, complying with EP / USP / ICH Q7 Peptide API Monograph with batch HPLC/MS CoA and regulatory documentation for African and global formulators.
| Item Code (SKU) | AKP-API-01 |
|---|---|
| CAS Registry No. | 74381-53-6 |
| Catalog Reference | AKP-API-01 · SN API-01 |
| Therapeutic Sector | Pharmaceutical Peptide APIs |
| Dosage Form | Lyophilized Peptide API |
| Active Ingredient | Leuprorelin Acetate (CAS 74381-53-6) |
| Strength / Purity | Purity ≥ 99.0% (HPLC) |
| Clinical Indication | Prostate cancer, Breast cancer |
| Specification Standard | EP / USP / ICH Q7 Peptide API Monograph |
| Packaging Format | Sealed Type I Glass Vial · Nitrogen Headspace (Bulk / Custom Weights) |
| Shelf Life | 24–36 Months (Lyophilized at -20°C) |
| Storage Conditions | Store lyophilized at -20°C (short-term 2–8°C); protect from moisture and light |
| Minimum Order Quantity | 50 Vials |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial & Regulatory Export Ready |