Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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1. 148411-57-8
2. 77224-08-9
3. (2r,3s,4r,5r,6s)-5-amino-6-[(2r,3s,4r,5r,6r)-5-amino-4,6-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-2-(hydroxymethyl)oxane-3,4-diol
4. 2-amino-4-o-(2-amino-2-deoxy-beta-d-glucopyranosyl)-2-deoxy-beta-d-glucopyranose
5. B-d-glucopyranose,2-amino-4-o-(2-amino-2-deoxy-b-d-glucopyranosyl)-2-deoxy-
6. (2r,3r,4r,5s,6r)-3-amino-5-{[(2s,3r,4r,5s,6r)-3-amino-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-(hydroxymethyl)oxane-2,4-diol
7. Deacetylated Chitin
8. Poly(d-glucosamine)
9. Schembl186177
10. Chebi:50677
11. Dtxsid80584131
12. Zinc25723126
13. Akos037515792
14. Cs-0239055
15. Chitosan Oligosaccharide Lactate, Average Mn 5,000
16. Q27122179
17. 4-o-(2-amino-2-deoxy-beta-d-glucopyranosyl)-beta-d-glucosamine
18. Wurcs=2.0/1,2,1/[a2122h-1b_1-5_2*n]/1-1/a4-b1
19. 2-amino-4-o-(2-amino-2-deoxy-
20. A-d-glucopyranosyl)-2-deoxy-
21. A-d-glucopyranose
Molecular Weight | 340.33 g/mol |
---|---|
Molecular Formula | C12H24N2O9 |
XLogP3 | -5.2 |
Hydrogen Bond Donor Count | 8 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 4 |
Exact Mass | 340.14818035 g/mol |
Monoisotopic Mass | 340.14818035 g/mol |
Topological Polar Surface Area | 201 Ų |
Heavy Atom Count | 23 |
Formal Charge | 0 |
Complexity | 390 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 10 |
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 : 17607
Submission : 2004-08-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25173
Submission : 2011-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14515
Submission : 1999-11-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32050
Submission : 2017-10-30
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14363
Submission : 1999-08-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16603
Submission : 2003-05-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17607
Submission : 2004-08-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25173
Submission : 2011-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32050
Submission : 2017-10-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14515
Submission : 1999-11-05
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14363
Submission : 1999-08-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16603
Submission : 2003-05-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Chitosan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chitosan Hydrochloride, including repackagers and relabelers. The FDA regulates Chitosan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chitosan Hydrochloride 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 Chitosan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chitosan Hydrochloride supplier is an individual or a company that provides Chitosan Hydrochloride active pharmaceutical ingredient (API) or Chitosan Hydrochloride finished formulations upon request. The Chitosan Hydrochloride suppliers may include Chitosan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Chitosan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chitosan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Chitosan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Chitosan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Chitosan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chitosan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Chitosan Hydrochloride USDMF includes data on Chitosan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chitosan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chitosan Hydrochloride suppliers with USDMF on PharmaCompass.
Chitosan Hydrochloride 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 Chitosan Hydrochloride 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 Chitosan Hydrochloride GMP manufacturer or Chitosan Hydrochloride GMP API supplier for your needs.
A Chitosan Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Chitosan Hydrochloride's compliance with Chitosan Hydrochloride specifications and serves as a tool for batch-level quality control.
Chitosan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Chitosan Hydrochloride 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.
Chitosan Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Chitosan Hydrochloride EP), Chitosan Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chitosan Hydrochloride USP).
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