Leuprorelin 99% Cas No.53714-56-0

Leuprorelin 99% Cas No.53714-56-0

Product Name: Leuprorelin
Source: N/A
Specification: ≥99%
CAS No.: 53714-56-0
Molecular Formula: C₅₉H₈₄N₁₆O₁₂
Molecular Weight: 1209.40 g/mol
Test Method: HPLC
Active Ingredient: Gonadotropin-Releasing Hormone (GnRH) Receptor Agonist
Product Characteristics: White to off-white powder or fluffy solid
Packaging: Available in various specifications (mg, g, kg), customizable
Storage Condition: Store in a cool, dry, and well-ventilated place. Keep the container tightly closed.
Shelf Life: 36 months
Declaration of Use: This product is intended for industrial use or scientific research only.
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Leuprorelin API | CAS 53714-56-0 | GnRH Agonist

Leuprorelin (also known as Leuprolide) is a highly potent synthetic nonapeptide analog of Gonadotropin-Releasing Hormone (GnRH). Engineered for advanced pharmaceutical research and development, Xi'an Tihealth Biotechnology Co., Ltd. supplies this active pharmaceutical ingredient (API) with an HPLC purity of ≥ 99.0%. Characterized by its profound resistance to enzymatic degradation and prolonged in vivo half-life, our Leuprorelin API is optimized for the formulation of sustained-release depot injections and targeted endocrine therapeutics.

⚠️ REGULATORY COMPLIANCE & RESEARCH USE ONLY (RUO)

Industrial R&D Application: This high-purity Leuprorelin is supplied strictly as a raw material API powder for professional laboratory research, biopharmaceutical development, and formulation trials. It is NOT a finished pharmaceutical drug and is explicitly prohibited for direct administration to humans or animals.

Chemical Profile & Specification Parameters

Analytical Parameter Xi'an Tihealth Specification
Generic Name Leuprorelin / Leuprolide
CAS Number 53714-56-0
Molecular Formula C59H84N16O12
Molecular Weight 1209.4 g/mol
Peptide Purity (HPLC) ≥ 99.0%
Appearance White to off-white lyophilized powder

Storage & Handling Protocols: Preserve in tight, light-resistant containers. Store strictly at -20°C in a desiccated environment to maintain peptide bond integrity. Allow the sealed vial to reach room temperature before opening to prevent condensation.

Pharmacodynamics & Mechanism of Action

Leuprorelin exerts its pharmacological action through a biphasic modulation of the hypothalamic-pituitary-gonadal (HPG) axis. It binds with high affinity to GnRH receptors on the membranes of pituitary gonadotrope cells:

  • Initial Stimulatory Phase: Acute administration stimulates the anterior pituitary gland, causing a transient surge in the release of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH), leading to a temporary increase in gonadal steroidogenesis.
  • Sustained Suppressive Phase: Continuous receptor occupancy by this degradation-resistant nonapeptide disrupts the physiological pulsatile signaling of endogenous GnRH. This induces rapid receptor desensitization and internalization.
  • Castration-Level Suppression: The resulting disconnection of the HPG axis leads to a profound and sustained suppression of LH and FSH secretion, ultimately reducing serum testosterone and estradiol to castration levels. This mechanism is entirely reversible upon cessation of exposure.

Therapeutic R&D Applications

Supplied strictly for pharmaceutical manufacturing and formulation development, Leuprorelin API is foundational for medications targeting hormone-dependent pathologies:

  • Oncology: Core API for depot formulations intended for the palliative treatment of advanced prostate cancer and the management of hormone receptor-positive breast cancer in pre/perimenopausal demographics.
  • Gynecological Disorders: Investigated for pre-operative treatment of uterine leiomyomas (fibroids) to reduce fibroid volume, and for the systemic symptom management of endometriosis.
  • Pediatric Endocrinology: Utilized in R&D for protocols designed to arrest the premature progression of Central Precocious Puberty (CPP).

Technical & Procurement FAQ

Can this API be utilized for the development of PLGA microsphere depot formulations?

Yes. Our Leuprorelin API is engineered with precise particle size distribution and exceptionally low moisture content, making it highly compatible with poly(lactic-co-glycolic acid) (PLGA) encapsulation technologies for 1-month, 3-month, or 6-month sustained-release injectables.

Is the API supplied as a base or a specific salt form?

Leuprorelin is standardly supplied as Leuprorelin Acetate to ensure optimal solubility and stability during the formulation process. Please specify if your R&D requires a different counter-ion during the inquiry phase.

What analytical validation accompanies commercial API batches?

Every batch released by Xi'an Tihealth is accompanied by a full analytical dossier, including the Certificate of Analysis (COA), explicit HPLC purity chromatograms, Electrospray Ionization Mass Spectrometry (ESI-MS) verification, and residual solvent testing compliant with international ICH Q3C guidelines.

Xi'an Tihealth Biotechnology Co., Ltd. Statement: Pharmaceutical API intended strictly for laboratory analysis and developmental pipeline research. Not for direct clinical administration.

 

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