WHO-GMP Certified Commercial Pack · Product Code: AKP-API-05
Linaclotide Peptide API
Peptide API Overview: Guanylate cyclase-C (GC-C) agonist 14-amino-acid peptide API formulated for irritable bowel syndrome with constipation (IBS-C) and CIC. Indicated for IBS-C, CIC. Supplied as lyophilized crystalline powder (Purity ≥ 99.0% HPLC, CAS 851199-59-2) 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-05 |
|---|---|
| CAS Registry No. | 851199-59-2 |
| Catalog Reference | AKP-API-05 · SN API-05 |
| Therapeutic Sector | Pharmaceutical Peptide APIs |
| Dosage Form | Lyophilized Peptide API |
| Active Ingredient | Linaclotide (CAS 851199-59-2) |
| Strength / Purity | Purity ≥ 99.0% (HPLC) |
| Clinical Indication | IBS-C, CIC |
| 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 |