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Fingolimod Hydrochloride or Fingolimod HCl USP EP BP Ph Eur Grade Supplier Exporter Manufacturers' Representative |
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Fingolimod Hydrochloride or Fingolimod HCl
CAS Number: 162359-56-0
Molecular Formula: C19H33NO2-HCl
Molecular Weight: 343.93
Fingolimod Hydrochloride or Fingolimod HCl
Fingolimod Hydrochloride USP NF Grade Specifications:
C19H33NO2-HCl --- 343.93
1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride;
2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride CAS 162359-56-0
Fingolimod (free base) C19H33NO2 --- 307.48 CAS 162359-55-9
DEFINITION
Fingolimod Hydrochloride contains NLT 98.0% and NMT 102.0% of fingolimod hydrochloride (C19H33NO2- HCl), calculated on anhydrous and solvent-free basis.
IDENTIFICATION
A. Spectroscopic Identification Tests, Infrared Spectroscopy.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay by chromatography.
C. Identification Tests—General Chemical Identification Tests, Chloride.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 0.5%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count is NMT 1000 cfu/g. Thetotal combined molds and yeasts count is NMT 100 cfu/g.
Packaging and Storage: Preserve in well-closed containers. Store below 30C in a dry place.
Fingolimod Hydrochloride or Fingolimod HCl is also available as per BP Ph Eur EP monograph.
Please visit SDS Safety Data Sheet of Fingolimod Hydrochloride or Fingolimod HCl Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org