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
Ronas Chemicals Ind.Co.,Ltd is a famiy group company that we have our own plant
for inorganic chemical manufacturing, and also working as a trading company to represent for our buyers and also working as a buying agent in China to helo our buyers soucring better quality with reasonable price., Moreover, we are helping our associate manufacturing of Amino Acid to be an sales team work in Taiwan, and also do the promotion over the world.
Amino acids and its derivate has wide range including L-amio acids, D-amino acids , DL-amino acids , Compound salts ,
N-Acetyl-amino acids, Fmoc protected amino acids, Boc Protected amino acids, CBZ protected amino acids, amino acids esters, amino acids Hcl,
4-aminobutyric acid, L-glutamine, L-glutamic acid, L-aspartic acid, DL-Methionine, DL-Isoleucine , L-serine, L-proline, L-alanine, L-leucine, L-isoleucine, L-cysteine Hcl Mono,
H-histidine, L-citrulline, L-VALINE , L-tyrosine, L-cystine, L-theanine, Beta Alanine, DL-alanine, L-lysine, glycine, L-hydroxyproline, L-methionine, FMOC-N-ME-VAL, N-acetyl-carnosine, PHE-PHE, VAL-TRP,
Acetyl Hexapeptide-8/argireline, Dipeptide diaminobutyroyl benzylamide diacetate, copper tripeptide-1/GHK-Cu, Nonapeptide-1/melitane
Palmitoyl Pentapeptide-4/Matrixyl acetate, SODIUM PCA , Hydroxypropyl tetrahydropyrantriol/Pro-xylane, Tetrahydropyrimidine/Ectoin, Decarboxy carnosine Hcl/Decarboxylation carnosine,
Peperidine compounds, Nitrogen Heterocyclic acid compounds,
Pyrrolidine Compounds, D-plenylglycinol, Thymulin , Thymalfasin , Octreotide acetate .
The ingredients for other industries are Bisphenol S, Bis(3-allyl-4hydroxyphenyl) sulfate, 2-acrylamide-2-methylpropane,
Ammonium persulfate, hydroxy propyl methyl cellulose, Re-dispersible emulsion powder,
polycarboxylate superplasticizer, Sodium persulfate , potassium persulfate, Potassium bromide , Sulfamic acid , Guanidine hcl ,
Guanidine thiocyanate, ARSENIC TRIOXIDE , and Gly-gly(N- Glycylglycine )。
Please feel free to contact us for more information and expect you to give us a chance
to work with you in near future.