Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium USP BP Ph Eur EP IP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium USP BP Ph Eur EP IP, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium CAS Number 630-93-3, EINECS EC Number: 211-148-2, Molecular Formula: C15H11N2NaO2, Molecular Weight: 274.25, HS Code 293329** or 29332100 or 29339900

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Phenytoin Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium.

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.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

MUBY CHEMICALS
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Sodium or 5,5-Diphenylhydantoin Sodium Salt or Dilantin Sodium
SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 20-Jan-23

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
Molecular Weight: 274.25
Chemical Formula: C15H11N2NaO2
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

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

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.
P264: Wash contaminated parts thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
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.
P308+P313: IF exposed or concerned: Get medical advice/ attention.
P360: Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P403 P404: Store in well-ventilated place. Keep container tightly closed.
P501: Dispose of contents/container in accordance with local/national regulation.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful
Xi Irritant
Risk Phrases:
R22 Harmful if swallowed.
R36 Irritating to eyes.
R43 May cause sensitization by skin contact.
R45 May cause cancer.
R60 May impair fertility.
R61 May cause harm to the unborn child.

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

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.
Physician may treat symptomatically.

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. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

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.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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. It will support combustion.

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. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
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 contact with skin and eyes. 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. This material will support combustion. Keep this and other chemicals out of reach of children. Storage: 2C to 8C, refrigerate. Short term shipping may be ambient.

Engineering Controls: The use of local exhaust ventilation is recommended to control emissions near the source. Provide mechanical ventilation of confined spaces. Use corrosion-resistant, explosion-proof ventilation equipment.
Exposure Limits: Not established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
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. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
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.

Appearance: White, slightly hygroscopic crystalline powder.
Odor: Odorless.
Odor threshold: Not applicable.
pH: Not applicable.
Relative density: Not available.
Melting point/freezing point: Not applicable.
Boiling Point: Not applicable.
Flash point: Not applicable.
Auto-ignition temperature: Not applicable.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor Pressure (MM Hg): Not applicable.
Vapor Density (Air = 1): Not available.
Evaporation Rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: It is soluble in water and alcohol.
Viscosity: Not available.
Molecular Weight: 274.25
Chemical Formula: C15H11N2NaO2

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.

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).

Toxicity to fish: Not available.
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: Not available.

Dispose in accordance with Local, State, and Federal Regulations. Consult local, state, or Federal Environmental Protection Agency before disposing of any chemicals.

DOT USA, TDG Canada & ADR/RID Europe: Not Regulated.
IMDG/IMO: Not Regulated.
ICAO/IATA: Not Regulated.

European Labeling in Accordance with EC Directives
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.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful
Xi Irritant
Risk Phrases:
R22 Harmful if swallowed.
R43 May cause sensitization by skin contact.
R45 May cause cancer.
R60 May impair fertility.
R61 May cause harm to the unborn child.

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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