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1. Eudragit Rl 100
2. Eudragit Rl-100
3. Eudragit Rs 100
4. Eudragit Rs100
5. Eudragit Rs30d
1. 33434-24-1
2. Ethyl Prop-2-enoate;methyl 2-methylprop-2-enoate;trimethyl-[2-(2-methylprop-2-enoyloxy)ethyl]azanium;chloride
3. Ethanaminium, N,n,n-trimethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]-, Chloride, Polymer With Ethyl 2-propenoate And Methyl 2-methyl-2-propenoate
4. Poly(ethyl Acrylate, Methyl Methacrylate, Trimethylammonioethyl Methacrylate Chloride)
Molecular Weight | 407.9 g/mol |
---|---|
Molecular Formula | C19H34ClNO6 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 10 |
Exact Mass | 407.2074655 g/mol |
Monoisotopic Mass | 407.2074655 g/mol |
Topological Polar Surface Area | 78.9 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 350 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 4 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7810
Submission : 1988-12-20
Status : Inactive
Type : II
ABOUT THIS PAGE
A Eudragit Rs manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eudragit Rs, including repackagers and relabelers. The FDA regulates Eudragit Rs manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eudragit Rs 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 Eudragit Rs supplier is an individual or a company that provides Eudragit Rs active pharmaceutical ingredient (API) or Eudragit Rs finished formulations upon request. The Eudragit Rs suppliers may include Eudragit Rs API manufacturers, exporters, distributors and traders.
click here to find a list of Eudragit Rs suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eudragit Rs DMF (Drug Master File) is a document detailing the whole manufacturing process of Eudragit Rs active pharmaceutical ingredient (API) in detail. Different forms of Eudragit Rs DMFs exist exist since differing nations have different regulations, such as Eudragit Rs USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eudragit Rs DMF submitted to regulatory agencies in the US is known as a USDMF. Eudragit Rs USDMF includes data on Eudragit Rs's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eudragit Rs USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eudragit Rs suppliers with USDMF on PharmaCompass.
Eudragit Rs 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 Eudragit Rs 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 Eudragit Rs GMP manufacturer or Eudragit Rs GMP API supplier for your needs.
A Eudragit Rs CoA (Certificate of Analysis) is a formal document that attests to Eudragit Rs's compliance with Eudragit Rs specifications and serves as a tool for batch-level quality control.
Eudragit Rs CoA mostly includes findings from lab analyses of a specific batch. For each Eudragit Rs 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.
Eudragit Rs may be tested according to a variety of international standards, such as European Pharmacopoeia (Eudragit Rs EP), Eudragit Rs JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eudragit Rs USP).
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