CAS Number 630-93-3, 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium IP BP EP Ph Eur USP Grade Manufacturers Exporters
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CAS Number 630-93-3, 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium IP BP EP Ph Eur USP Manufacturer Exporter
For Properties Specifications of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium Click Properties, Specifications of Phenytoin Sodium Manufacturer.
For Uses of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium Click Uses of Phenytoin Sodium Manufacturer.
For For SDS MSDS Sheet of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium Click SDS Safety Data Sheet MSDS Sheet of Phenytoin Sodium Manufacturer.
The Properties and Specifications of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium:
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.
TESTS
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.
We also supply Phenytoin Sodium IP EP Grade.
The Uses of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium:
Phenytoin is used to prevent and control seizures.
The MSDS-SDS Hazard Statement of 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium:
Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 12-nov-24
1. Product Identification
Product Name & Other Names: Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
CAS Number: 630-93-3
EINECS EC Number: 211-148-2
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, Oral Category 4, H302
Skin sensitization, Category 1, H317
Carcinogenicity, Category 2, H351
Reproductive toxicity Category 2, H361
Long-term (chronic) aquatic hazard, Category 3, H412
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
GHS Label Elements |
Signal Words: Warning
Hazard Statements:
H302: Harmful if swallowed.
H317: May cause an allergic skin reaction.
H351: Suspected of causing cancer.
H361: Suspected of damaging fertility or the unborn child.
Precautionary Statements:
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P301+P310: IF SWALLOWED: Immediately call a POSION CENTER or doctor/physician.
P314: Get medical advice/attention if you feel unwell.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P302+352: IF ON SKIN: Wash with plenty of soap and water.
P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
P403+P404: Store in well-ventilated place. Keep container tightly closed.
3. Composition/Information on Ingredients
Product Name & Other Names: Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
CAS Number: 630-93-3
EINECS EC Number: 211-148-2
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Remove affected person to fresh air; if normal breathing has not returned within a few minutes after exposure, get medical attention.
Skin: Remove contaminated clothing; wash affected area with soap and water; launder contaminated clothing before reuse. Seek medical attention.
Eyes: Immediately, flush eyes for 15 minutes in clear running water while holding eyelids open; seek medical attention immediately.
Ingestion: Drink two glasses of water followed by milk, milk of magnesia or other non-alcoholic liquids; Do not induce vomiting; seek medical attention immediately.
5. Fire Fighting Measures
General Hazards: Product will support combustion.
Extinguishing Media: Carbon dioxide, water fog, dry chemical, chemical foam. Keep containers cool by spraying with water. Use extinguishing media appropriate for surrounding fire. Avoid solid water jet as it may scatter fire.
Fire & Explosion Hazard: May evolve oxides of carbon (COx), oxides of nitrogen and fumes under fire conditions.
In case of fire, wear a full face positive-pressure self-contained breathing apparatus and protective suit. Self - contained respiratory equipment; cool containers to prevent pressure buildup and explosion when exposed to extreme heat. Caution - material will support combustion!
Unusual Fire and Explosion Hazards: Closed containers can explode due to buildup of pressure when exposed to extreme heat.
Hazardous Combustion Products: Products of combustion include CO, CO2, NOx and toxic fumes.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter sewer, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. Vacuum or sweep up and remove to an approved disposal container.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents and acids. Keep containers closed when not in use; protect containers from abuse; protect from extreme temperatures, open flames. Keep this and other chemicals out of reach of children. Storage: 2C to 8C, refrigerate.
8. Exposure Controls/Personal Protection
Engineering Controls: The use of local exhaust ventilation is recommended to control emissions near the source. Provide mechanical ventilation of confined spaces.
Exposure Limits: Not established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White, slightly hygroscopic crystalline powder.
Odor: Odorless.
Odor threshold: Not applicable.
pH: No data found.
Relative density: No data found.
Melting point/freezing point: No data found.
Boiling Point: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor Pressure (MM Hg): No data found.
Vapor Density (Air = 1): No data found.
Evaporation Rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: It is soluble in water and alcohol.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable at normal temperatures and operating conditions.
Conditions to Avoid: Avoid excessively high temperatures and contact with strong oxidizing agents.
Incompatibilities: Oxidizing agents and acids.
Decomposition: Decomposition yields nitrogen oxides, carbon monoxide & dioxide, fumes along with sodium compounds.
Polymerization: Polymerization will not occur.
11. Toxicological Information
Acute Oral Effects: Oral LD50 – Rats 1530 mg/kg.
Reproduction: Possible risk of harm to the unborn child.
Mutagenicity: Not mutagenic in AMES Test or via micronucleus test on mice.
Carcinogenicity: PHENYTOIN is listed in group 2b (possibly carcinogenic to humans).
12. Ecological Information
Toxicity to fish: No data found.
Persistence and accumulation: Bioaccumulation is unlikely.
Mobility: Will likely be mobile in the environment due to its water solubility.
Results of PBT and vPvB assessment: No data found.
13. Disposal Considerations
Dispose in accordance with Local, State, and Federal Regulations. Follow all the pollution control rules.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
ICAO/IATA: Not dangerous goods.
15. Regulatory Information
UNITED STATES REGULATORY INFORMATION
SARA 311/312: See section 2.
Section 16 - Additional Information
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium Structure
CAS Number 630-93-3, 5,5-Diphenylhydantoin Sodium Salt or Phenytoin Sodium Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 19-nov-24
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