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1. Nkp-1339
2. Rucl4(1h-indazole)2
3. Bold-100
4. Kp 1339
5. Kp-1339
6. Kp1339
7. Sodium Trans-(tetrachlorido-bis(1h-indazole)ruthenate(iii))
1. It-139
2. Rucl4(1h-indazole)2
3. Unii-7osj9ks483
4. Bold-100
5. Chebi:176975
6. Kp1339
7. Sodium Trans-[tetrachloridobis(1h-indazole)ruthenate(iii)]
8. Sodium Tetrachloro[bis(1h-indazole-kappan(2))]ruthenate(1-)
Molecular Weight | 502.1 g/mol |
---|---|
Molecular Formula | C14H12Cl4N4NaRu+ |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 0 |
Exact Mass | 502.872767 g/mol |
Monoisotopic Mass | 500.875717 g/mol |
Topological Polar Surface Area | 57.4 Ų |
Heavy Atom Count | 24 |
Formal Charge | 1 |
Complexity | 313 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 4 |
ABOUT THIS PAGE
A IT-139 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IT-139, including repackagers and relabelers. The FDA regulates IT-139 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IT-139 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 IT-139 supplier is an individual or a company that provides IT-139 active pharmaceutical ingredient (API) or IT-139 finished formulations upon request. The IT-139 suppliers may include IT-139 API manufacturers, exporters, distributors and traders.
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 IT-139 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for IT-139 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 IT-139 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 IT-139 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a IT-139 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of IT-139 suppliers with NDC on PharmaCompass.
IT-139 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 IT-139 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 IT-139 GMP manufacturer or IT-139 GMP API supplier for your needs.
A IT-139 CoA (Certificate of Analysis) is a formal document that attests to IT-139's compliance with IT-139 specifications and serves as a tool for batch-level quality control.
IT-139 CoA mostly includes findings from lab analyses of a specific batch. For each IT-139 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.
IT-139 may be tested according to a variety of international standards, such as European Pharmacopoeia (IT-139 EP), IT-139 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (IT-139 USP).
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