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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NDC API
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FDF
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FDA Orange Book
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Europe
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Canada
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Australia
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South Africa
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1. Schembl145070
Molecular Weight | 982.8 g/mol |
---|---|
Molecular Formula | C12H22O35S8 |
XLogP3 | -8.6 |
Hydrogen Bond Donor Count | 8 |
Hydrogen Bond Acceptor Count | 35 |
Rotatable Bond Count | 21 |
Exact Mass | 981.7707318 g/mol |
Monoisotopic Mass | 981.7707318 g/mol |
Topological Polar Surface Area | 604 Ų |
Heavy Atom Count | 55 |
Formal Charge | 0 |
Complexity | 2230 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36552
Submission : 2022-02-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11533
Submission : 1995-05-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9475
Submission : 1992-01-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9475
Submission : 1992-01-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36552
Submission : 2022-02-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11533
Submission : 1995-05-25
Status : Inactive
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sucrosofate Ammonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucrosofate Ammonium, including repackagers and relabelers. The FDA regulates Sucrosofate Ammonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucrosofate Ammonium 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 Sucrosofate Ammonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucrosofate Ammonium supplier is an individual or a company that provides Sucrosofate Ammonium active pharmaceutical ingredient (API) or Sucrosofate Ammonium finished formulations upon request. The Sucrosofate Ammonium suppliers may include Sucrosofate Ammonium API manufacturers, exporters, distributors and traders.
click here to find a list of Sucrosofate Ammonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucrosofate Ammonium DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucrosofate Ammonium active pharmaceutical ingredient (API) in detail. Different forms of Sucrosofate Ammonium DMFs exist exist since differing nations have different regulations, such as Sucrosofate Ammonium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucrosofate Ammonium DMF submitted to regulatory agencies in the US is known as a USDMF. Sucrosofate Ammonium USDMF includes data on Sucrosofate Ammonium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucrosofate Ammonium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucrosofate Ammonium suppliers with USDMF on PharmaCompass.
Sucrosofate Ammonium 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 Sucrosofate Ammonium 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 Sucrosofate Ammonium GMP manufacturer or Sucrosofate Ammonium GMP API supplier for your needs.
A Sucrosofate Ammonium CoA (Certificate of Analysis) is a formal document that attests to Sucrosofate Ammonium's compliance with Sucrosofate Ammonium specifications and serves as a tool for batch-level quality control.
Sucrosofate Ammonium CoA mostly includes findings from lab analyses of a specific batch. For each Sucrosofate Ammonium 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.
Sucrosofate Ammonium may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucrosofate Ammonium EP), Sucrosofate Ammonium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucrosofate Ammonium USP).
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