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1. Cid 16132441
2. Dtxsid50160461
| Molecular Weight | 6985 g/mol |
|---|---|
| Molecular Formula | C287H446N80O111S6 |
| XLogP3 | -43.2 |
| Hydrogen Bond Donor Count | 106 |
| Hydrogen Bond Acceptor Count | 122 |
| Rotatable Bond Count | 234 |
| Exact Mass | 6984.0138989 g/mol |
| Monoisotopic Mass | 6981.0038343 g/mol |
| Topological Polar Surface Area | 3110 Ų |
| Heavy Atom Count | 484 |
| Formal Charge | 0 |
| Complexity | 18500 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 63 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Lepirudin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lepirudin, including repackagers and relabelers. The FDA regulates Lepirudin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lepirudin 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 Lepirudin supplier is an individual or a company that provides Lepirudin active pharmaceutical ingredient (API) or Lepirudin finished formulations upon request. The Lepirudin suppliers may include Lepirudin API manufacturers, exporters, distributors and traders.
Lepirudin 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 Lepirudin 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 Lepirudin GMP manufacturer or Lepirudin GMP API supplier for your needs.
A Lepirudin CoA (Certificate of Analysis) is a formal document that attests to Lepirudin's compliance with Lepirudin specifications and serves as a tool for batch-level quality control.
Lepirudin CoA mostly includes findings from lab analyses of a specific batch. For each Lepirudin 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.
Lepirudin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lepirudin EP), Lepirudin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lepirudin USP).
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