Hormone Therapy Leuprolide Acetate

Leuprolide Acetate (CAS 53714-56-0) is a synthetic nonapeptide widely used as a potent GnRH agonist in human and veterinary applications. Our API is supplied as high-purity lyophilized powder with full regulatory documentation, supporting formulation, scale-up, and commercial production.

Technical Specifications

• Chemical Name: Leuprolide Acetate
• CAS Number: 53714-56-0
• Grade: Pharmaceutical-grade lyophilized peptide
• Form: White to off-white lyophilized powder (hygroscopic)
• Purity: ≥ 98% (HPLC) with detailed COA
• Solubility: Soluble in sterile water and standard peptide-grade buffers
• Storage:
• -Short-term: 2–8 °C
• -Long-term: −20 °C (sealed, protected from moisture/light)
• -Avoid repeated freeze–thaw cycles
• Documentation: COA, MSDS/TDS, stability profile, impurity data, additional analytical reports on request
• Packaging Options: Small evaluation vials, bulk vials/drums, OEM/private-label available

Why Manufacturers Prefer Our Leuprolide Acetate

• Pharmaceutical-Grade Consistency: Every lot is fingerprint-matched using validated analytical methods for reproducibility across multiple production runs.
• Optimized for Peptide Stability: Lyophilized form minimizes degradation during storage and transport.
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• Designed for Real-World Formulation Needs:
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• Avoid high-pH conditions
• Do not expose to oxidizing agents
• Use fresh sterile buffers for reconstitution
• Sterile-filter before forming final solutions or depot matrices
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• Supported by Full Technical Data:
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• R&D formulation
• Scale-up
• GMP production
• Filing and quality audits

Procurement & Scale-Up Workflow

• Step 1 – Sample Evaluation: Order small vials to validate analytical methods, solubility, and formulation compatibility.
• Step 2 – Bulk Supply Arrangement: After successful validation, coordinate bulk production with batch traceability and predictable lead times.
• Step 3 – Production & Logistics Planning: Align with production schedule to ensure continuous availability and long-term supply.

Packaging & Shipment

• Sealed vials with protective desiccant
• Temperature-controlled (cold-chain) shipping available
• Insulated export-safe packaging for long-distance transport
• Door-to-door delivery with documented handling instructions

Frequently Asked Questions (FAQs)

• Q1: Can I request a COA or analytical profile before purchase?
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  A: Yes, COA and key analytical data are available with samples or upon request.
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• Q2: How should Leuprolide Acetate be handled after reconstitution?
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  A: Use immediately or follow TDS storage guidelines. Do not refreeze.
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• Q3: What are the lead times for bulk orders?
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  A: Lead time depends on order volume and production schedule. Firm timeline provided in the quotation.