| CAS No.: | 630-93-3 |
| Molecular Weight: | 274.25 g/mol |
| Chemical Formula | C15H11N2NaO2 |
Phenytoin is used to prevent and control seizures. It is a white, odorless, slightly hygroscopic crystalline powder. It is soluble in water and alcohol.
General Properties and Specifications of Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium as per IP:
Appearance: White, slightly hygroscopic crystalline powder.
Odor: Odorless.
Assay: 98% minimum.
Identification:
a) By IR.
b) White precipitate is formed when dissolved in water and acidified with dilute hydrochloric acid.
c) Dissolve in pyridine and cupric sulfate with pyridine solution and allow to stand. Blue precipitate is formed.
d) After incineration, neutralize residue with hydrochloric acid. Addition of water gives reaction of sodium salt as per IP.
Appearance of the solution: Suspend in water and dilute with sodium hydroxide. Solution is clear and not more intensely colored than the reference solution.
Free Phenytoin: Not more than 0.1 ml of 0.1M sodium hydroxide is required to change the color to pink.
Related substances:
Impurity C: 0.2% maximum.
Impurity D: 0.15% maximum.
Impurity E: 0.3% maximum.
Total impurities: 0.5% maximum.
Heavy metals: 20 ppm maximum.
Water: 3% maximum.
Solubility: It is soluble in water and alcohol.
Storage: 2C to 8C, refrigerate. Short term shipping may be ambient.
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 BP Ph Eur Grade:
C15H11N2NaO2 --- 274.3 CAS 630-93-3
Action and use: Antiepileptic.
DEFINITION
Sodium 4-oxo-5,5-diphenyl-4,5-dihydro-1H-imidazol-2-olate.
Content: 98.5 per cent to 100.5 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white, crystalline powder, slightly hygroscopic.
Solubility: Soluble in water and in ethanol (96 per cent), practically insoluble in methylene chloride.
IDENTIFICATION
First identification: A, C
Second identification: B, C
A. Infrared absorption spectrophotometry.
B. Thin-layer chromatography.
C. Ignite 1 g and cool. Add 2 mL of water to the residue and neutralise the solution with hydrochloric acid. Filter and dilute the filtrate to 4 mL with water. 0.1 mL of the solution gives reaction (b) of sodium.
