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Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium USP EP BP Ph Eur IP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium SDS of Manufacturers
Synonyms: Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
CAS Number: 630-93-3, Molecular Weight: 274.25, Chemical Formula: C15H11N2NaO2, EINECS EC Number: 211-148-2, FEMA: ----,
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.
Appearance of solution: Suspend 1.0 g in 5 mL of water and dilute to 20 mL with 0.1 M sodium hydroxide. The solution is clear and not more intensely coloured than reference solution.
Related substances: To pass the test.
Free phenytoin: To pass the test.
Water: Maximum 3.0 per cent, determined on 1.000 g.
Keywords: Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 630-93-3 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
1-mar-24
Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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Phenytoin Sodium
5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium IP BP Ph Eur EP USP Grades Manufacturers