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Phenytoin Sodium Grade USP EP BP Ph Eur Grade Supplier Exporter Manufacturers' Representative |
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Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
CAS Number: 630-93-3
Molecular Formula: C15H11N2NaO2
Molecular Weight: 274.25
Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
Phenytoin is used to prevent and control seizures.
Phenytoin Sodium USP Grade Specifications:
C15H11N2NaO2 --- 274.25
2,4-Imidazolidinedione, 5,5-diphenyl-, monosodium salt;
5,5-Diphenylhydantoin sodium salt CAS 630-93-3
UNII: 4182431BJH
UNII: 6158TKW0C5
DEFINITION
Phenytoin Sodium contains NLT 98.0% and NMT 102.0% of phenytoin sodium (C15H11N2NaO2), calculated on the dried basis.
IDENTIFICATION
A. Infrared Absorption
B. Identification Tests—General, Sodium: To pass the test.
Organic Impurities:
Phenytoin related compound A Acceptance Criteria, NMT 0.5%
Phenytoin related: compound B Acceptance Criteria, 0.9%
Phenytoin Relative Retention Time 1.0
Benzophenone Acceptance Criteria, 0.1%
Any individual unspecified impurity Acceptance Criteria, 0.10%
Total impurities Acceptance Criteria, 0.9% Excluding benzophenone.
Loss on Drying: Dry at 105C for 4 h. Acceptance criteria: NMT 2.5%
Phenytoin Sodium is also available as per BP Ph Eur EP monograph
Please visit SDS Safety Data Sheet of Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium 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
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