Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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Europe
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Australia
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South Africa
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Listed Dossiers
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USP
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Molecular Weight | 853.9 g/mol |
---|---|
Molecular Formula | C44H55NO16 |
XLogP3 | 1.8 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 16 |
Exact Mass | 853.35208467 g/mol |
Monoisotopic Mass | 853.35208467 g/mol |
Topological Polar Surface Area | 244 A^2 |
Heavy Atom Count | 61 |
Formal Charge | 0 |
Complexity | 1780 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 2 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
ABOUT THIS PAGE
A Mac321 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mac321, including repackagers and relabelers. The FDA regulates Mac321 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mac321 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 Mac321 supplier is an individual or a company that provides Mac321 active pharmaceutical ingredient (API) or Mac321 finished formulations upon request. The Mac321 suppliers may include Mac321 API manufacturers, exporters, distributors and traders.
click here to find a list of Mac321 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mac321 DMF (Drug Master File) is a document detailing the whole manufacturing process of Mac321 active pharmaceutical ingredient (API) in detail. Different forms of Mac321 DMFs exist exist since differing nations have different regulations, such as Mac321 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mac321 DMF submitted to regulatory agencies in the US is known as a USDMF. Mac321 USDMF includes data on Mac321's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mac321 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mac321 suppliers with USDMF on PharmaCompass.
Mac321 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 Mac321 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 Mac321 GMP manufacturer or Mac321 GMP API supplier for your needs.
A Mac321 CoA (Certificate of Analysis) is a formal document that attests to Mac321's compliance with Mac321 specifications and serves as a tool for batch-level quality control.
Mac321 CoA mostly includes findings from lab analyses of a specific batch. For each Mac321 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.
Mac321 may be tested according to a variety of international standards, such as European Pharmacopoeia (Mac321 EP), Mac321 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mac321 USP).
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