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1. .gama.-cyclodextrin
2. Schardinger Gamma-dextrin
3. Mfcd00009595
4. Schembl180792
5. Octakis(hydroxymethyl)[?]hexadecol
6. Ls-15485
7. Sy007957
8. Cyclooctakis-(1->4)-(a-d-glucopyranose)
9. Ft-0626609
| Molecular Weight | 1297.1 g/mol |
|---|---|
| Molecular Formula | C48H80O40 |
| XLogP3 | -17.2 |
| Hydrogen Bond Donor Count | 24 |
| Hydrogen Bond Acceptor Count | 40 |
| Rotatable Bond Count | 8 |
| Exact Mass | 1296.4225873 g/mol |
| Monoisotopic Mass | 1296.4225873 g/mol |
| Topological Polar Surface Area | 633 Ų |
| Heavy Atom Count | 88 |
| Formal Charge | 0 |
| Complexity | 1720 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 40 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
API SUPPLIERS
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11375
Submission : 1995-03-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37142
Submission : 2022-08-05
Status : Active
Type : IV
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37142
Submission : 2022-08-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11375
Submission : 1995-03-09
Status : Active
Type : IV
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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APIs
Reply
18 Nov 2020
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Gamma-Cyclodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gamma-Cyclodextrin, including repackagers and relabelers. The FDA regulates Gamma-Cyclodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gamma-Cyclodextrin 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 Gamma-Cyclodextrin supplier is an individual or a company that provides Gamma-Cyclodextrin active pharmaceutical ingredient (API) or Gamma-Cyclodextrin finished formulations upon request. The Gamma-Cyclodextrin suppliers may include Gamma-Cyclodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Gamma-Cyclodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gamma-Cyclodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gamma-Cyclodextrin active pharmaceutical ingredient (API) in detail. Different forms of Gamma-Cyclodextrin DMFs exist exist since differing nations have different regulations, such as Gamma-Cyclodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gamma-Cyclodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Gamma-Cyclodextrin USDMF includes data on Gamma-Cyclodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gamma-Cyclodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gamma-Cyclodextrin suppliers with USDMF on PharmaCompass.
Gamma-Cyclodextrin 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 Gamma-Cyclodextrin 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 Gamma-Cyclodextrin GMP manufacturer or Gamma-Cyclodextrin GMP API supplier for your needs.
A Gamma-Cyclodextrin CoA (Certificate of Analysis) is a formal document that attests to Gamma-Cyclodextrin's compliance with Gamma-Cyclodextrin specifications and serves as a tool for batch-level quality control.
Gamma-Cyclodextrin CoA mostly includes findings from lab analyses of a specific batch. For each Gamma-Cyclodextrin 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.
Gamma-Cyclodextrin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gamma-Cyclodextrin EP), Gamma-Cyclodextrin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gamma-Cyclodextrin USP).
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