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1. Mmae
2. 474645-27-7
3. Schembl16645126
4. Ex-a636
5. Monomethyl Auristatin E (vedotin)
6. Akos032947340
7. D09691
| Molecular Weight | 718.0 g/mol |
|---|---|
| Molecular Formula | C39H67N5O7 |
| XLogP3 | 4.1 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 20 |
| Exact Mass | 717.50404949 g/mol |
| Monoisotopic Mass | 717.50404949 g/mol |
| Topological Polar Surface Area | 150 Ų |
| Heavy Atom Count | 51 |
| Formal Charge | 0 |
| Complexity | 1100 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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ABOUT THIS PAGE
A Monomethyl Auristatin E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monomethyl Auristatin E, including repackagers and relabelers. The FDA regulates Monomethyl Auristatin E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monomethyl Auristatin E API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Monomethyl Auristatin E manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monomethyl Auristatin E supplier is an individual or a company that provides Monomethyl Auristatin E active pharmaceutical ingredient (API) or Monomethyl Auristatin E finished formulations upon request. The Monomethyl Auristatin E suppliers may include Monomethyl Auristatin E API manufacturers, exporters, distributors and traders.
click here to find a list of Monomethyl Auristatin E suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monomethyl Auristatin E DMF (Drug Master File) is a document detailing the whole manufacturing process of Monomethyl Auristatin E active pharmaceutical ingredient (API) in detail. Different forms of Monomethyl Auristatin E DMFs exist exist since differing nations have different regulations, such as Monomethyl Auristatin E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monomethyl Auristatin E DMF submitted to regulatory agencies in the US is known as a USDMF. Monomethyl Auristatin E USDMF includes data on Monomethyl Auristatin E's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monomethyl Auristatin E USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monomethyl Auristatin E suppliers with USDMF on PharmaCompass.
Monomethyl Auristatin E 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 Monomethyl Auristatin E 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 Monomethyl Auristatin E GMP manufacturer or Monomethyl Auristatin E GMP API supplier for your needs.
A Monomethyl Auristatin E CoA (Certificate of Analysis) is a formal document that attests to Monomethyl Auristatin E's compliance with Monomethyl Auristatin E specifications and serves as a tool for batch-level quality control.
Monomethyl Auristatin E CoA mostly includes findings from lab analyses of a specific batch. For each Monomethyl Auristatin E 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.
Monomethyl Auristatin E may be tested according to a variety of international standards, such as European Pharmacopoeia (Monomethyl Auristatin E EP), Monomethyl Auristatin E JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Monomethyl Auristatin E USP).
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