Leuprorelin Acetate API Manufacturer | GMP Peptide API Supplier

Core Selling Points

GMP-grade Leuprorelin Acetate API for pharmaceutical formulation development
Well-established GnRH agonist peptide with extensive clinical development history
≥98% HPLC purity with strict related substance control per pharmacopoeia standards
Full batch traceability and complete regulatory documentation package
DMF technical dossier support for pharmaceutical regulatory submissions
Stable bulk supply capacity from R&D grams to commercial kilograms
Custom peptide synthesis and formulation development technical support

What Is Leuprorelin Acetate (Leuprolide)?

Leuprorelin Acetate API, also known as Leuprolide Acetate, is a synthetic nonapeptide analogue of gonadotropin-releasing hormone (GnRH / LH-RH), classified as a potent GnRH agonist peptide API. It is a well-established GnRH agonist peptide with extensive clinical development history and broad application in global pharmaceutical product development.

The molecule features amino acid substitutions at positions 6 (D-Leu) and 10 (ethylamide), which enhance receptor binding affinity and metabolic stability compared to native GnRH. Like other GnRH agonists, it initially stimulates pituitary gonadotropin release (LH and FSH), leading to a transient rise in sex hormone levels. With continuous administration, it causes receptor downregulation and desensitization, resulting in suppressed gonadotropin secretion and profound suppression of sex hormone production in pharmaceutical applications.

Manufactured through GMP-aligned solid-phase peptide synthesis and precision HPLC purification, our Leuprorelin Acetate API meets major pharmacopoeia standards with strict impurity control, making it suitable for pharmaceutical regulatory submissions and finished product development.

What Are the Official Quality Specifications of Leuprorelin Acetate API?

Every production batch of Leuprorelin Acetate API undergoes rigorous analytical testing in HDM BIO's in-house QC laboratory, with a unique batch COA issued for all bulk orders.

Item	Specification	Result
Appearance	White to off-white powder	Consistent
Purity (HPLC)	≥98%	99.66%
MS Identity	Consistent with reference standard	Confirmed
Conclusion	Cosmetic raw material requirement	Passed

What Are the Pharmaceutical Applications of Leuprorelin Acetate API?

Deslorelin acts as a potent GnRH receptor agonist. Upon initial administration, it stimulates the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland. With continued administration, it downregulates GnRH receptors, leading to suppression of gonadotropin secretion and consequently reducing sex hormone production (testosterone and estrogen) - a mechanism that supports reversible fertility suppression in animals.

It has been used in veterinary pharmaceutical products in several markets for indications including ovulation induction in mares, management of benign prostatic hyperplasia (BPH) in dogs, and long-term reversible fertility control in various animal species.

How Does Leuprorelin Acetate Compare With Other GnRH Agonist Peptide APIs?

Peptide API	Potency vs Native GnRH	Key Structural Modifications	Common Formulation Types
Leuprorelin (Leuprolide)	50-80x	D-Leu6, Pro9-NHEt	Injectable depot (microspheres), SC injection, implant
Deslorelin Acetate	144x	D-Trp6, Pro9-NHEt	SC implant (primarily veterinary)
Goserelin Acetate	100x	D-Ser(tBu)6, AzaGly10-NH₂	SC biodegradable implant
Triptorelin Acetate	100x	D-Trp6	Injectable depot (microspheres), IM/SC injection

Leuprorelin Acetate API Price & Bulk Supply

Leuprorelin Acetate API price depends on order quantity, purity grade, packaging specifications and required documentation services. As a direct Leuprorelin Acetate manufacturer, HDM BIO provides competitive bulk quotations for pharmaceutical manufacturers, API distributors and research organizations.

We support flexible order scales:

R&D sample orders (gram-scale) for feasibility testing
Pilot-scale batches for formulation development
Commercial kilogram-scale bulk supply for mass production

Contact our sales team for the latest Leuprorelin Acetate bulk price and lead time information.

What Should Pharmaceutical Buyers Check Before Purchasing Leuprorelin Acetate API?

When sourcing Leuprorelin Acetate API for pharmaceutical development, buyers should verify the following key criteria to ensure regulatory compliance and product quality:

GMP-aligned manufacturing capability and clean production environment
HPLC purity specification and related substances impurity profile
Batch-specific COA with full QC testing data
Mass spectrometry identity confirmation and amino acid analysis
Available stability data and shelf-life documentation
Complete regulatory dossier support for filing submissions
Manufacturer's export experience and global logistics capability
Custom synthesis and impurity reference standard support

Why Choose HDM BIO as Your Leuprorelin Acetate Supplier?

As an experienced GMP peptide API manufacturer in China, HDM BIO provides end-to-end support for Leuprorelin Acetate procurement and product development:

GMP-aligned closed production workshops with full raw material traceability
Mature SPPS synthesis technology with precise stereochemical control at D-Leu6
Multi-stage HPLC purification platform for pharmacopoeia-grade impurity control
Strict batch-to-batch consistency with full QC documentation release
Comprehensive technical dossier support for regulatory submissions
Flexible production capacity from R&D grams to commercial kilograms
Dedicated technical team supporting formulation development and troubleshooting

How Is Leuprorelin Acetate API Manufactured Under GMP Conditions?

Production Workflow

Raw Material Inspection → Fmoc SPPS Sequential Coupling (9 Amino Acid Sequence with D-Leu6 Control) → Resin Cleavage → Deprotection → HPLC Purification → Ion Exchange (Acetate Salt Conversion) → Lyophilization → QC Testing → Batch COA & Documentation → Sealed Pharmaceutical-Grade Packaging

QC Inspection Workflow

Incoming Raw Material QC → In-process Production Monitoring → HPLC Purity Testing → Related Substances Profiling → Mass Spectrometry Identity Verification → Amino Acid Analysis → Peptide Content Determination → Water Content (KF) → Residual Solvent Testing → Heavy Metal Testing → Bacterial Endotoxin Testing → Sterility Testing (if applicable) → Final Batch Release Approval

Key Process Highlights

All synthesis processes run inside GMP-aligned clean workshops with full raw material traceability. The nonapeptide sequence (pGlu-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt) requires precise stereochemical control at the D-Leu6 position and ethylamide modification at Pro9. Multi-stage high-precision HPLC purification achieves pharmacopoeia-grade purity with stringent related substance control. Finished Leuprorelin Acetate API is vacuum and temperature-controlled packed under pharmaceutical-grade conditions with comprehensive batch documentation.

How Can Pharmaceutical Developers Optimize Leuprorelin Acetate Formulations?

Sustained-release systems: PLGA/PLA microsphere technology is most commonly employed for 1-month, 3-month and 6-month depot formulations.
Peptide stability: Protect from moisture; lyophilized powder is stable at -20°C; solution stability requires careful pH and temperature control.
Analytical requirements: HPLC purity, related substances, peptide content, acetate content, water content and residual solvents are critical quality attributes per pharmacopoeial standards.
Regulatory considerations: Pharmacopoeial monograph compliance (USP/EP), ICH guideline adherence for impurities and stability studies.
Excipient compatibility: Evaluate compatibility with PLGA polymers, mannitol, carboxymethylcellulose and other depot formulation excipients.

What Are the Most Frequently Asked Questions About Leuprorelin Acetate?

Q: Who is a reliable Leuprorelin Acetate supplier in China?

A: HDM BIO is a China-based peptide API manufacturer supplying Leuprorelin Acetate with GMP-controlled production, batch COA and full technical documentation. We support both R&D samples and commercial bulk supply for global pharmaceutical clients.

Q: Can you supply bulk Leuprorelin Acetate API?

A: Yes, as a professional Leuprorelin Acetate manufacturer, we supply bulk quantities from gram-scale R&D batches to kilogram-scale commercial production. Contact us for customized bulk pricing and lead time.

Q: What documents are available for Leuprorelin Acetate procurement?

A: Each batch is supplied with a full set of quality documentation including COA, MSDS, HPLC chromatogram, mass spectrum report, amino acid analysis, water content and residual solvent data. Technical dossiers for regulatory filing are available for qualified buyers.

Q: What is Leuprorelin Acetate (Leuprolide)?

A: Leuprorelin Acetate, also known as Leuprolide Acetate, is a synthetic nonapeptide GnRH/LH-RH agonist. It initially stimulates then suppresses pituitary gonadotropin secretion, leading to significant reduction in sex hormone production. It is a widely established peptide API in global pharmaceutical development.

Q: What is the CAS number of Leuprorelin Acetate?

A: The CAS number of Leuprorelin Acetate (Leuprolide Acetate acetate salt) is 74381-53-6. The free base CAS is 53714-56-0.

Q: What is the molecular formula and weight of Leuprorelin?

A: The molecular formula is C₅₉H₈₄N₁₆O₁₂ with a molecular weight of 1209.40 g/mol (free base). The acetate salt form contains additional acetic acid equivalents.

Q: Is Leuprorelin Acetate manufactured under GMP?

A: Yes, HDM BIO manufactures Leuprorelin Acetate under GMP-aligned production conditions with full ICH-compliant QC testing, batch documentation and impurity profiling.

Q: Can HDM BIO provide DMF support for Leuprorelin Acetate?

A: Technical documentation packages including process description, specifications, analytical methods, impurity profiles and stability data can be provided to support regulatory submissions. Please inquire for specific requirements.

Q: What purity specification is available for Leuprorelin Acetate?

A: Our standard specification is ≥98% HPLC purity with strict related substance controls. Higher purity grades may be available upon request for specific pharmaceutical applications.

Q: Where can I buy bulk Leuprorelin Acetate?

A: You can buy Leuprorelin Acetate API directly from HDM BIO. We supply from gram-scale R&D quantities to commercial kilogram-scale, with flexible pricing and full technical documentation for qualified pharmaceutical buyers.

Q: What is the difference between Leuprorelin and Leuprolide?

A: Leuprorelin and Leuprolide refer to the same peptide molecule. "Leuprorelin" is the International Nonproprietary Name (INN), while "Leuprolide" is the United States Adopted Name (USAN). The acetate salt form (CAS 74381-53-6) is the most commonly supplied pharmaceutical form.

Technical & Compliance Review

Technical Reviewer

Senior Peptide API R&D Specialist

Expertise: Solid Phase Peptide Synthesis, GnRH analog process development, GMP quality system management, pharmaceutical impurity control, regulatory dossier preparation

Last Reviewed: July 2026

Manufacturer: HDM BIO

Location: China

Production Standard: GMP-aligned, ISO, HACCP certified

Pharmacopoeia References: USP Leuprolide Acetate Monograph; European Pharmacopoeia Leuprorelin Acetate Monograph

Review Scope: Process validation, specification review, impurity profiling and quality documentation compliance

Category: Synthetic peptide active pharmaceutical ingredient (API)

Intended Applications: Pharmaceutical manufacturing, compounding and legitimate research use

Important Regulatory Notice

Leuprorelin Acetate (Leuprolide Acetate) is a synthetic peptide active pharmaceutical ingredient (API). This product is supplied for pharmaceutical manufacturing, compounding and legitimate research purposes. Purchasers are responsible for compliance with all applicable regulatory requirements in their jurisdiction, including obtaining necessary DEA or equivalent controlled substance licenses where required, marketing authorizations and import/export permits. This product requires a valid prescription when formulated into finished drug products. All page content is for B2B pharmaceutical raw material procurement reference only.