Divalproex sodium is used to treat certain types of seizures (epilepsy). This medicine is an anticonvulsant that works in the brain tissue to stop seizures. Divalproex sodium is also used to treat the manic phase of bipolar disorder (manic-depressive illness), and helps prevent migraine headaches.

Certificate of Analysis

• Description

  White to almost white powder.

  Result

  White powder

• Solubility

  Very soluble in chloroform, freely Soluble in Methanol and in Ethyl ether. Soluble in Acetone, practically insoluble in Acetonitrile.)

  Result

  Complies

• Identification

  Infra-red spectrum of the sample should confirm with reference standard Spectrum. The sample responds to the test of sodium.

  Result

  Infra-red spectrum of the sample confirms With reference standard spectrum. b) The sample responds to the test of sodium.

• Water (by Karl fisher)

  Not more than 1.00%

  Result

  0.45 %

• Heavy metals

  Not more than 0.002 %

  Result

  Less than 0.002 %

• Assay

  Not less than 98.0 % and not more than 102.0 % on dried basis.

  Result

  99.96 %

• Content of Sodium valproate

  Between 53.5 – 56.5% on dried basis

  Result

  54.75 %

• Content of Valproic acid

  Between 43.5- 46.5 % on dried basis.

  Result

  45.60 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Divalproex Sodium

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Divalproex Sodium

  Synonym

  2-propyl pentatonic acid, sodium salt

  Molecular Formula

  C8H16O2.C8H15O2.Na

  Molecular Weight

  310.41

  CAS Number

  76584-70-8

• Section 3 – HAZARDOUS IDENTIFICATION

  Emergency Overview

  Harmful if swallowed.

  Potential Health Effects

  The toxicological properties of this material have not been investigated. Use appropriate procedures to prevent opportunities for direct contact with the skin or eyes and to prevent inhalation. Compound is Non-hazardous, Non-Toxic/Non-Flammable.

• Section 4 – FIRST AID

  Eyes

  Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids.

  Skin

  Flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes.

  Ingestion

  Do NOT induce vomiting. If conscious and alert, rinse mouth and drink 2-4 cup flus of milk or water.

  Inhalation

  Remove from exposure and move to fresh air immediately.

• Section 5 – FIRE FIGHTING MEASURES

  General Information

  As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.

  Extinguishing Media

  In case of fire, use water, dry chemical, chemical foam, or alcohol-resistant foam.

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Use proper personal protective equipment as indicated in Section 8.

  Spills/Leaks

  Clean up spills immediately, observing precautions in the Protective Equipment section. Sweep up, then place into a suitable container for disposal.

• Section 7 – HANDLING AND STORAGE

  Handling

  Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation.

  Storage

  Store in a well closed container.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Use adequate general or local exhaust ventilation to keep airborne concentrations below the permissible exposure limits. Use process enclosure, local exhaust ventilation, or other engineering controls to control airborne levels.

  Personal Protective Equipment

  Eyes

  Wear safety glasses and chemical goggles if splashing is possible.

  Skin

  Wear appropriate protective gloves and clothing to prevent skin exposure.

  Clothing

  Wear appropriate protective clothing to minimize contact with skin.

  Respirators

  Wear a NIOSH/MSHA or European Standard EN 149 approved full-face piece airline respirator in the positive pressure mode with emergency escape provisions.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Crystalline powder

  Color

  White

  Odor

  Odorless

  Freezing / Melting Point

  100°C

  Boiling Point

  N/A

  Flash Point

  N/A

  Auto-Ignition Temperature

  N/A

  Refractive Index

  N/A

  Density

  N/A

  Decomposition Temperature

  N/A

  Solubility

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable under normal temperatures and pressures.

  Conditions to Avoid

  Incompatible materials, strong oxidants

  Incompatibilities with Other Materials

  Strong oxidizing agents, strong bases.

  Hazardous Decomposition Products

  Nitrogen oxides, carbon monoxide, irritating and toxic fumes and gases, carbon dioxide, nitrogen.

  Hazardous Polymerization

  Has not been reported.

• Section 11 – TOXICOLOGICAL INFORMATION

  RTECS#:

  CAS#76584-70-8

  N/A

  LD50/LC50

  RTECS-Not available

  Carcinogenicity

  Divalproex sodium – Not listed as a carcinogen by ACGIH, IARC, NTP, or CA Prop 65.

• Section 12 – ECOLOGICAL INFORMATION

  Data Not Available.

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state and local environmental regulations.

• Section 14 – TRANSPORT INFORMATION

  Non-hazardous for transport

  This substance is considered to be non-hazardous for transport.

• Section 15 – REGULATORY INFORMATION

  European/International Regulations

  Hazard Symbols

  T

  Indication of Danger

  Toxic

  Risk Phrases

  R 22

  Harmful if swallowed

  R 36/38

  Irritating to eyes and skin.

  R 61

  May cause harm to the unborn child.

  Safety Phrases

  S 26

  In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

  S 36/37/39

  Wear suitable protective clothing, gloves and eye/face protection.

  S 45

  In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

  S 53

  Avoid exposure – obtain special instructions before use.

  WGK (Water Danger/Protection)

  CAS#76584-70-8

  N/A

  Canada

  CAS#76584-70-8 is not listed on Canada’s Ingredient Disclosure List

  US Federal

  TSCA

  CAS# 76584-70-8 is not listed on the TSCA Inventory. It is for research and development use only.

• Section 16 – OTHER INFORMATION

  Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

  Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

  GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION.