Résumé du produit
Leuprorelin Acetate Peptide (CAS 53714‑56‑0) Product Name: Leuprorelin Acetate / Leuprolide Acetate CAS No.: 53714‑56‑0 (base); 74381‑53‑6 (acetate) Molecular Formula: C₅₉H₈₄N₁₆O₁₂ · xC₂H₄O₂ Molecular Weight: ~1273.57 (free base) Grade: Pharmaceutical Grade / Injectable Grade API Appearance: White ...
GMP factory supply high purity leuprorelin peptide CAS 53714-56-0 with CEP leuprorelin powder
Propriétés de base
Propriétés commerciales
GMP factory leuprorelin peptide powder
,high purity leuprorelin CAS 53714-56-0
,CEP certified leuprorelin powder
Leuprorelin Acetate Peptide (CAS 53714‑56‑0)
- High purity ≥98.5% by HPLC
- Low endotoxin, suitable for injectable formulations
- Strict impurity control for long‑acting depot development
- Complete COA, MSDS, NMR, MS, TGA, KF reports
- Stable cold‑chain supply and fast global delivery
- Custom packaging: 1g, 5g, 10g, 50g, 100g, bulk
| Test Item | Standard | Typical Result |
|---|---|---|
| Description | White to off‑white lyophilized powder | Conforms |
| CAS No. | 53714‑56‑0 | Conforms |
| Assay (Peptide Content) | 95.0% – 105.0% | 98.7% |
| Purity (HPLC) | ≥98.5% | 99.3% |
| Maximum Single Impurity | ≤1.0% | 0.4% |
| Acetic Acid Content | 3.0% – 8.0% | 5.2% |
| Water Content (Karl Fischer) | ≤5.0% | 2.6% |
| Specific Optical Rotation | −22° to −18° | −20.1° |
| pH (1% aqueous solution) | 4.0 – 6.0 | 4.9 |
| Bacterial Endotoxins | ≤5 EU/mg | <2 EU/mg |
| Sterility | Complies | Complies |
| Heavy Metals | ≤10 ppm | <5 ppm |
| Residual Solvents | In accordance with ICH Q3C | Complies |
| Storage | 2–8°C, sealed, dry, avoid light | Recommended |
| Shelf Life | 24 months | Valid |
Main Applications
- Prostate cancer (hormone‑dependent)
- Breast cancer (pre‑ and perimenopausal)
- Endometriosis
- Uterine leiomyoma (fibroids)
- Central precocious puberty (CPP)
- In vitro fertilization (IVF) protocols
- Long‑acting sustained‑release microsphere formulations
Quality & Compliance
- GMP production environment
- EP / USP in‑house testing standard
- Full traceability from raw material to finished product
- TSE/BSE free, non‑animal origin
- Stable quality for long‑term cooperative clients
Packaging & Shipping
- Inner: Sealed sterile vial with desiccant
- Outer: Aluminum bag + carton
- Shipping: Cold chain (2–8°C) with temperature recorder
- Support custom labeling and neutral packaging
Order Info
- MOQ: 1g
- Lead time: 1–2 weeks (in stock)
- Full export documents: COA, MSDS, TDS, GMP, shipping papers
- Technical support for formulation R&D
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