Synopsis
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Molecular Weight | 346.20 g/mol |
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Molecular Formula | C14H8N2Na2O6 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 3 |
Exact Mass | 346.01777454 g/mol |
Monoisotopic Mass | 346.01777454 g/mol |
Topological Polar Surface Area | 142 A^2 |
Heavy Atom Count | 24 |
Formal Charge | 0 |
Complexity | 587 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 1 |
Covalently Bonded Unit Count | 3 |
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Olsalazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olsalazine, including repackagers and relabelers. The FDA regulates Olsalazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olsalazine 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 Olsalazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olsalazine supplier is an individual or a company that provides Olsalazine active pharmaceutical ingredient (API) or Olsalazine finished formulations upon request. The Olsalazine suppliers may include Olsalazine API manufacturers, exporters, distributors and traders.
click here to find a list of Olsalazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olsalazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Olsalazine active pharmaceutical ingredient (API) in detail. Different forms of Olsalazine DMFs exist exist since differing nations have different regulations, such as Olsalazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olsalazine DMF submitted to regulatory agencies in the US is known as a USDMF. Olsalazine USDMF includes data on Olsalazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olsalazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olsalazine suppliers with USDMF on PharmaCompass.
A Olsalazine written confirmation (Olsalazine WC) is an official document issued by a regulatory agency to a Olsalazine manufacturer, verifying that the manufacturing facility of a Olsalazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olsalazine APIs or Olsalazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Olsalazine WC (written confirmation) as part of the regulatory process.
click here to find a list of Olsalazine suppliers with Written Confirmation (WC) 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 Olsalazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olsalazine 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 Olsalazine 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 Olsalazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olsalazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olsalazine suppliers with NDC on PharmaCompass.
Olsalazine 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 Olsalazine 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 Olsalazine GMP manufacturer or Olsalazine GMP API supplier for your needs.
A Olsalazine CoA (Certificate of Analysis) is a formal document that attests to Olsalazine's compliance with Olsalazine specifications and serves as a tool for batch-level quality control.
Olsalazine CoA mostly includes findings from lab analyses of a specific batch. For each Olsalazine 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.
Olsalazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Olsalazine EP), Olsalazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olsalazine USP).
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