Lanreotide Acetate Powder Cas No.127984-74-1

Lanreotide Acetate Powder Cas No.127984-74-1

Product Name: Lanreotide Acetate API Powder
Product source: Chemical synthesis (Solid-Phase Peptide Synthesis - SPPS), purified via high-performance liquid chromatography (HPLC), and lyophilized as an acetate salt
Content specification: Pharmaceutical Grade (API) ≥ 99.0%; Research Grade (RUO) ≥ 98.0%
CAS NO:127984-74-1
Detection method: HPLC (Assay Purity) & ESI-MS (Molecular Weight and Sequence Verification)
Active ingredient: Lanreotide Acetate
Product Description: White to off-white lyophilized powder
Product use: Pharmaceutical formulation development (e.g., sustained-release depot injections); Professional laboratory research
Product packaging: 1. Pharmaceutical Grade: Packaged in sterile vials or double-sealed PE bags within aluminum-plastic composite foil pouches (1g, 5g, 10g, up to bulk scale), packed in export-grade fiber drums with desiccants;
2. Research Grade: Packaged in amber glass vials (100mg, 500mg), sealed within foil pouches under inert gas (nitrogen) to prevent oxidation and moisture degradation.
Product storage: Long-term storage strictly at -20 ℃ in a sealed, dark, and desiccated environment. Avoid repeated freeze-thaw cycles.
Shelf life: 24 months under intact recommended storage conditions; After reconstitution: It is recommended to store at 2-8 ℃ and utilize within 24-48 hours to ensure peptide integrity.
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Lanreotide Acetate API Powder | CAS 127984-74-1 | High-Purity Somatostatin Analog

Serving as a critical somatostatin analog, Lanreotide Acetate is a synthetic cyclic octapeptide renowned for its prolonged endocrine suppression capabilities. Xi'an Tihealth Biotechnology Co., Ltd. specializes in the robust synthesis of this active pharmaceutical ingredient (API), delivering an assay purity consistently exceeding 99.0% (HPLC). The acetate salt configuration is purposefully engineered to meet the rigorous solubility, hydration, and biophysical demands required for formulating advanced extended-release injectables and conducting complex neuroendocrine research.

⚠️ REGULATORY COMPLIANCE & STRICT RESEARCH USE ONLY (RUO)

Laboratory & Manufacturing Restriction: This Lanreotide Acetate compound is classified exclusively as a bulk active pharmaceutical ingredient (API) intended for professional in-vitro research, preclinical trials, and commercial drug formulation pipelines. It is strictly forbidden to utilize this raw powder for direct human or veterinary administration.

Molecular Specifications & Quality Metrics

Analytical Parameter Xi'an Tihealth Specification
Generic Name Lanreotide Acetate
CAS Number 127984-74-1
Molecular Formula C54H69N11O10S2 · xC2H4O2
Molecular Weight 1096.3 g/mol (based on free peptide)
Chromatographic Purity (HPLC) ≥ 99.0%
Physical State White to off-white lyophilized powder

Handling & Stability Directives: To prevent oxidation and the disruption of critical disulfide bonds, the API must be stored in a hermetically sealed, moisture-free environment at -20°C. Ensure vials equilibrate to ambient temperature prior to opening to avoid hygroscopic moisture uptake.

Receptor Pharmacology & Endocrine Modulation

The biological mechanism of Lanreotide Acetate relies on its profound affinity for specific somatostatin receptor subtypes, predominantly orchestrating systemic secretory inhibition:

  • Targeted SSTR Activation: It mimics endogenous somatostatin but offers a significantly extended half-life, forcefully binding to peripheral SSTR2 and SSTR5 receptors located on the pituitary and pancreas.
  • Hormonal Downregulation: Directly attenuates the hypersecretion pathways of Growth Hormone (GH) and Insulin-like Growth Factor-1 (IGF-1), which are the primary pathological drivers in specific pituitary adenomas.
  • Gastrointestinal Pathway Suppression: Exerts comprehensive inhibitory control over exocrine and endocrine GI peptides (including VIP, gastrin, and serotonin), thereby mitigating the severe vasomotor symptoms associated with functional neuroendocrine tumors.

Industrial Formulation & Clinical R&D Focus

As a premium pharmaceutical precursor, this acetate-form API enables the development of therapeutics across several critical domains:

  • Extended-Release Delivery Systems: Serves as the primary raw material for engineering high-concentration, deep subcutaneous depot formulations (such as liquid-crystal autogels and biodegradable PLGA microspheres).
  • Endocrinology Pipelines: Utilized in the creation of generic equivalents aimed at normalizing GH/IGF-1 levels in post-surgical acromegaly patients.
  • Oncology Symptom Management: A foundational compound for investigating treatments that alleviate the debilitating flushing and secretory diarrhea inherent to Carcinoid Syndrome.

API Procurement & Technical FAQ

What makes the Acetate salt preferable for SR depot manufacturing?

The acetate counter-ion optimizes the peptide's hydration dynamics. This specific stoichiometry is essential for the spontaneous formation of supersaturated liquid-crystalline nanostructures, which is the foundational technology behind prolonged-release "Autogel" injections compared to the free base form.

Are there specific microbial and endotoxin controls for this API?

Absolutely. Recognizing its primary use in parenteral (injectable) formulation R&D, Xi'an Tihealth provides designated batches that undergo rigorous Limulus Amebocyte Lysate (LAL) testing to ensure endotoxin levels remain below stringent thresholds (typically < 0.5 EU/mg), alongside comprehensive bioburden monitoring.

What analytical data packages are available for generic drug developers?

We supply a complete analytical dossier to support ANDA and global regulatory filings. This encompasses Batch Manufacturing Records (BMR), precise HPLC chromatograms detailing impurity profiles, Mass Spectrometry (MS) for sequence confirmation, and ICH-compliant residual solvent analyses.

Xi'an Tihealth Biotechnology Co., Ltd. Quality Commitment: GMP-aligned pharmaceutical API intended for laboratory analysis and R&D manufacturing scale-up.

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