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1. (dota(0)-phe(1)-tyr(3))octreotide
2. Dotatoc
3. Smt 487
4. Smt-487
1. Dotatoc
2. Smt-487
3. Smt 487
4. 204318-14-9
5. Chembl408350
6. U194as08hz
7. 173606-11-6
8. Edotreotide [usan]
9. Edotreotide [usan:inn]
10. Unii-u194as08hz
11. Dota-toc Acetate
12. Dota-toc
13. N-acetyl-lys-octreotide
14. Edotreotide [mi]
15. Edotreotide [inn]
16. Schembl1649285
17. Smt487
18. Schembl19712197
19. Dtxsid701021591
20. Ex-a4065
21. Bdbm50165171
22. Hy-106033
23. Cs-0024683
24. Q908790
25. L-cysteinamide, N-((4,7,10-tris(carboxymetnyl)-1,4,7,10-tetraazacyclodec-1-yl)acetyl)-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-, Cyclic(2->7)-disulfide
26. L-cysteinamide, N-((4,7,10-tris(carboxymetnyl)-1,4,7,10-tetraazacyclodec-1-yl)acetyl)-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryptophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-, Cyclic(2-7)-disulfide
27. N-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l Cysteinamide Cyclic (2-7)-disulfide
28. N-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l-cysteinamide Cyclic (2->7)-disulfide
29. N-((4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacycoldodec-1-yl)acetyl-d-phenylalanyl-l-cysteinyl-l-tyrosyl-d-tryprophyl-l-lysyl-l-threonyl-n-((1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl)-l-cysteinamide Cyclic (2-7)-disulfide
Molecular Weight | 1421.6 g/mol |
---|---|
Molecular Formula | C65H92N14O18S2 |
XLogP3 | -7.2 |
Hydrogen Bond Donor Count | 17 |
Hydrogen Bond Acceptor Count | 25 |
Rotatable Bond Count | 26 |
Exact Mass | 1420.61554449 g/mol |
Monoisotopic Mass | 1420.61554449 g/mol |
Topological Polar Surface Area | 531 Ų |
Heavy Atom Count | 99 |
Formal Charge | 0 |
Complexity | 2620 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 10 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
This medicinal product is for diagnostic use only.
After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Radiopharmaceuticals
Compounds that are used in medicine as sources of radiation for radiotherapy and for diagnostic purposes. They have numerous uses in research and industry. (Martindale, The Extra Pharmacopoeia, 30th ed, p1161) (See all compounds classified as Radiopharmaceuticals.)
V09IX
Global Sales Information
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Edotreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edotreotide, including repackagers and relabelers. The FDA regulates Edotreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edotreotide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Edotreotide supplier is an individual or a company that provides Edotreotide active pharmaceutical ingredient (API) or Edotreotide finished formulations upon request. The Edotreotide suppliers may include Edotreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Edotreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edotreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Edotreotide active pharmaceutical ingredient (API) in detail. Different forms of Edotreotide DMFs exist exist since differing nations have different regulations, such as Edotreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edotreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Edotreotide USDMF includes data on Edotreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edotreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edotreotide suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Edotreotide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Edotreotide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Edotreotide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Edotreotide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Edotreotide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Edotreotide suppliers with NDC on PharmaCompass.
Edotreotide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Edotreotide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Edotreotide GMP manufacturer or Edotreotide GMP API supplier for your needs.
A Edotreotide CoA (Certificate of Analysis) is a formal document that attests to Edotreotide's compliance with Edotreotide specifications and serves as a tool for batch-level quality control.
Edotreotide CoA mostly includes findings from lab analyses of a specific batch. For each Edotreotide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Edotreotide may be tested according to a variety of international standards, such as European Pharmacopoeia (Edotreotide EP), Edotreotide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Edotreotide USP).
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