WHO-GMP Certified Commercial Pack · Product Code: AKP-API-09
Etelcalcetide HCl Peptide API
Peptide API Overview: Calcimimetic D-amino-acid peptide API for intravenous management of secondary hyperparathyroidism (SHPT) in haemodialysis patients. Indicated for Secondary hyperparathyroidism (SHPT). Supplied as lyophilized crystalline powder (Purity ≥ 99.0% HPLC, CAS 1334237-71-6) 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-09 |
|---|---|
| CAS Registry No. | 1334237-71-6 |
| Catalog Reference | AKP-API-09 · SN API-09 |
| Therapeutic Sector | Pharmaceutical Peptide APIs |
| Dosage Form | Lyophilized Peptide API |
| Active Ingredient | Etelcalcetide HCl (CAS 1334237-71-6) |
| Strength / Purity | Purity ≥ 99.0% (HPLC) |
| Clinical Indication | Secondary hyperparathyroidism (SHPT) |
| 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 |