Application
1.
Neuroendocrine Tumor Treatment: Octreotide is commonly used in the treatment of neuroendocrine tumors such as pancreatic islet cell tumors, carcinoid tumors, and pheochromocytomas. It helps slow down the progression of the disease by inhibiting tumor cell growth and secretion
2.
Acromegaly and Gigantism: Octreotide is used to manage acromegaly, a condition characterized by excessive growth (hormone )production, and gigantism, which occurs due to excessive growth (hormone) production in childhood. It helps control hormone levels and reduces symptoms associated with these conditions
3.
Thyroid-Associated Eye Disease: Octreotide can be employed in the treatment of thyroid-associated eye disease, also known as Graves' ophthalmopathy. It helps alleviate symptoms such as eye inflammation, swelling, and discomfort.
4.
Variceal Bleeding: Octreotide is used to manage variceal bleeding, which is bleeding from enlarged veins in the esophagus or stomach. It helps reduce blood flow to the affected area and minimizes the risk of bleeding.
5.
Dumping Syndrome: Octreotide can be utilized to treat dumping syndrome, a condition that occurs after certain types of surgeries, such as gastric bypass surgery. It helps slow down the emptying of the stomach and reduces symptoms like nausea, vomiting, and diarrhea.
6.
Insulinoma: Octreotide is used in the management of insulinoma, a rare tumor of the pancreas that causes excessive i nsulin production. It helps control the release of i nsulin and manages symptoms associated with low blood sugar levels.
7.
Carcinoid Syndrome: Octreotide is employed to alleviate symptoms of carcinoid syndrome, which can occur due to certain types of neuroendocrine tumors. It helps reduce hormone secretion and controls symptoms like flushing, diarrhea, and wheezing.
8.
Parameter | Specification | Result |
Appearance | White to off-white powder | Complies |
Identification | Conforms to reference standard | Complies |
Purity (by HPLC) | ≥ 98% | 99.50% |
Molecular Weight | 1019.2 g/mol | 1019.6 g/mol |
Water Content | ≤ 5.0% | 2.10% |
Acetate Content | ≤ 15.0% | 12.80% |
Peptide Content | ≥ 95% | 96.20% |
Solubility | Soluble in water, sparingly soluble in methano l | Complies |
Storage | Store at -20°C | Complies |
Heavy Metals | ≤ 20 ppm | < 10 ppm |
Microbiological Testing | ||
Total Aerobic Microbial Count | ≤ 1000 CFU/g | < 10 CFU/g |
Total Yeast and Mold Count | ≤ 100 CFU/g | < 10 CFU/g |
Escherichia coli | Absence | Absent |
Salmonella | Absence | Absent |
Staphylococcus aureus | Absence | Absent |
Pseudomonas aeruginosa | Absence | Absent |
Assay (by HPLC) | ≥ 95% | 97.30% |
Conclusion | The product meets the specified requirements. |
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