OCTREOTIDE ACETATE CAS NO 83150-76-9 C49H66N10O10S

 

TEST		SPECIFICATION		RESULT
	Appearance	White or almost white powder		Conform
	Solubility	Soluble in water and acetic acid, insoluble in aether		Conform
Identity by HPLC		The retention is the same with the reference substance		Conform
Clarity and Color of Solution		Clear and Colorless		Conform
Specific Optical Rotation		-66.0‘ -76.0‘		-75.7‘
Water Content (Karl Fischer)				4.5%
Acetic Acid (By HPLC)		5.0% 12.0%		9.2%
Peptide Purity (By HPLC)		98.0%		99.7%
	Related Substance (By HPLC)		Total Impurities(%) 2%	0.3%
		Largest Single Impurity(%) 1.0%		0.1%
Organic Solvent Residue			Acetonitrile 0.041%	< 0.041%
		Dichloromethane 0.06%		< 0.060%
		N,N-Dimethylformamide 0.088%		0.088%
Conclusion: the product conforms with Chinese Pharmacopoeia and qualified

Octreotide is an artificially synthesized octapeptide derivative of natural somatostatin, which retains the same pharmacological effects as somatostatin but has a long-lasting effect. It can inhibit the pathological secretion increase of growth hormone (GH) and peptides and serotonin produced by the gastrointestinal pancreatic (GEP) endocrine system. In animal bodies, octreotide has stronger inhibitory effects on the release of growth hormone, glucagon, and insulin than somatostatin, as well as stronger selectivity for GH and glucagon. Long term (26 weeks) administration, doses of 1 mg/kg/day (intraperitoneal injection) in rats and 0.5 mg/kg/day (intravenous injection) in dogs were well tolerated. Research on healthy subjects has shown that octreotide, similar to somatostatin, can inhibit the release of growth hormone caused by hypoglycemia induced by arginine, exercise, or insulin. The secretion of insulin, glucagon, gastrin, and other peptides in the GEP system after meals, as well as the secretion of insulin and glucagon caused by arginine. The release of thyroid stimulating hormone (TSH) stimulated by thyrotropin releasing hormone (TRH). Unlike somatostatin, octreotide has a better inhibitory effect on GH than on insulin, and there is no increase in hormone rebound secretion after administration (such as GH in patients with limb hypertrophy). For patients with acromegaly, this product - long-acting octreotide microspheres for injection - is suitable for repeated administration every 4 weeks and can continuously produce therapeutic serum octreotide levels, thereby maintaining a sustained decrease in GH levels and normalizing serum IGF-1. In most patients, this product can significantly improve their clinical symptoms, such as headache, excessive sweating, sensory disorders, fatigue, joint pain, and carpal tunnel syndrome. It has been reported that after administration of this product, the tumor size of a small number of GH secreting pituitary adenoma patients has decreased

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