Octreotide Acetate (CAS 79517 - 01 - 4)

Product Introduction

I.                  Core Product Characteristics

Chemical & Physical Properties

(A) Properties and Structure

Octreotide acetate bulk drug appears as a white powder or lyophilized powder, exhibiting excellent chemical stability under normal storage conditions. To maximize its biological activity, storage at -20°C under lyophilized and light-protected conditions is recommended. Chemically, it is a synthetic octapeptide compound, serving as an analog of the tetradecapeptide somatostatin. With a molecular formula of C₅₁H₇₀N₁₀O₁₂S₂ and a molecular weight of approximately 1079.29, its molecular structure contains two cysteine residues that cyclize the polypeptide chain through a disulfide bond. This unique structural design is crucial for maintaining its biological activity, laying a solid foundation for downstream formulation production.

(B) Fundamental Mechanism of Action

Octreotide acetate bulk drug has a well-defined mechanism of action, serving as the core for the efficacy of numerous formulations. It binds to somatostatin receptors (SSTR) in the human body, with a higher affinity for SSTR2 and SSTR5. Upon binding, it inhibits the activity of adenylate cyclase, reducing the intracellular production of cAMP, thereby suppressing the secretion of various hormones such as growth hormone, insulin, etc. Additionally, it regulates ion channels, influencing cellular functions. Its mechanisms of action in the digestive and vascular systems provide a reliable basis for developing formulations for treating diseases such as acromegaly and gastroenteropancreatic endocrine tumors.

II. Diverse Application Values

(A) High-Quality Raw Material for Formulation Production

As a bulk drug, octreotide acetate is the key raw material for producing various formulations. It can be used to prepare long-acting sustained-release formulations for acromegaly, effectively controlling growth hormone levels in patients who have failed surgery, radiotherapy, or treatment with dopamine receptor agonists, or those who are unable or unwilling to undergo surgery, and alleviating symptoms such as enlarged hands and feet and facial changes. It can also be used to develop formulations for relieving symptoms associated with gastroenteropancreatic endocrine tumors. For carcinoid tumors with carcinoid syndrome, VIPomas, glucagonomas, etc., it improves symptoms like facial flushing, diarrhea, and hyperglycemia by inhibiting related hormone secretion.

(B) Raw Material for Preventive and Emergency Formulations

Octreotide acetate bulk drug is indispensable for producing formulations to prevent postoperative pancreatic complications. Clinically proven, injection formulations made from this raw material, when used before surgery, can inhibit pancreatic secretion, reduce the risk of complications such as pancreatic fistula and infection, and promote postoperative recovery. Furthermore, for the emergency treatment of esophageal-gastric variceal bleeding caused by liver cirrhosis, formulations prepared from this bulk drug can be used in conjunction with endoscopic sclerotherapy. They achieve rapid hemostasis by reducing splanchnic blood flow and portal venous pressure, buying time for further treatment.

III. Outstanding Competitive Advantages

(A) High Activity and Stability

During the production process, octreotide acetate bulk drug is strictly controlled using advanced technologies to ensure its high biological activity and chemical stability. Thanks to its unique molecular structure, it demonstrates stronger inhibitory effects on hormones like growth hormone and glucagon compared to similar raw materials, guaranteeing the high efficacy of downstream formulations. Its stable chemical properties also prevent deterioration during formulation production and storage, extending the shelf life of the formulations.

(B) Strong Formulation Adaptability

This bulk drug features excellent physical and chemical properties, allowing it to flexibly adapt to various formulation production processes. Whether made into injections, lyophilized powder injections, or long-acting sustained-release formulations, it maintains stable performance and biological activity. Its good solubility and dispersibility facilitate mixing with other excipients, meeting the production requirements of different dosage forms and providing convenience for pharmaceutical companies to develop diversified products.

(C) Quality and Regulatory Advantages

Manufactured in strict accordance with international advanced production standards and quality management systems, every production step, from raw material procurement to finished product delivery, undergoes rigorous testing. The product quality complies with the standards of various pharmacopoeias, such as the Chinese Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia, ensuring unimpeded global market circulation and providing partners with high-quality, reliable, and compliant raw materials.