Valproate (VPA), and its valproic acid, sodium valproate, and divalproex sodium forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches. It is useful for the prevention of seizures in those with absence seizures, partial seizures, and generalized seizures. It can be given intravenously or by mouth. Long and short acting formulations exist.

Certificate of Analysis

• Description

  A White or almost White crystalline Powder, hygroscopic.

  Result

  A White crystalline Powder, hygroscopic.

• Solubility

  Very soluble in water & in ethanol (96 %)

  Result

  Complies.

• Identification

  The infra-red absorption spectrum is concordant with the reference spectrum of sodium valproate. (b) The retention time of the principle peak in the chromatogram obtained with test solution Correspondence to that of the principle peak in the chromatogram obtained with reference solution. (C) Hence white precipitate is produced indicating is produced indicating test solution gives reaction of sodium salts.

  Result

  The infra-red absorption spectrum is concordant with the reference spectrum of sodium valproate. (b) The retention time of the principle peak in the chromatogram obtained with test soln. Correspondence to that of the principle peak in the chromatogram obtained with reference soln. (C) Hence white precipitate is produced indicating is produced indicating test solution gives reaction of sodium salts.

• Acidity & alkalinity

  0.75 ml either 0.1 M HCL or 0.1M NaOH required to change the colour of the solution.

  Result

  0.1 ml of 0.1 M HCL changes the colour of the solution.

• Clarity & colour of the Solution

  20 % w/v solution is not more opalescent than opalescence of reference sustention II & is not more intensely coloured than reference solution Y6.

  Result

  20 % w/v solution is less than opalescent than opalescence of reference sustention II. The solution is less intensely coloured than reference solution Y6.

• Heavy Metals

  Not more than 20 ppm.

  Result

  Less than 20 ppm.

• Chlorides

  Not more than 200 ppm.

  Result

  Less than 200 ppm.

• Sulphate

  Not more than 200 ppm.

  Result

  Less than 200 ppm.

• Related substances

  Sum of total impurities not more than 0.3% / Individual impurity not more than 0.1 %

  Result

  Sum of total impurities less than 0.3 % / Individual impurity less than 0.1 %

• Loss on drying

  Not more than 2.00 %

  Result

  0.9 %

• Assay (on dry basis)

  Between 98.5 % to 101.0 % calculated on dry basis.

  Result

  99.47 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Sodium Valproate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Sodium Valproate

  Synonym

  2-Propylpentanoic acid, sodium salt

  Molecular Formula

  C12H15N3O2S

  Molecular Weight

  166.2

  CAS Number

  1069-66-5

• Section 3 – HAZARDOUS IDENTIFICATION

  Emergency Overview

  Harmful if swallowed. Irritating to eyes and skin. May cause harm to the unborn child.

  Potential Health effects

  Eyes

  Causes eye irritation

  Skin

  Causes skin irritation. May be harmful if absorbed through the skin.

  Ingestion

  Harmful if swallowed. May cause irritation of the digestive tract. May cause digestive tract disturbances. May cause alopecia (loss of hair).

  Inhalation

  May cause respiratory tract irritation. May be harmful if inhaled.

  Chronic

  Possible risk of harm to the unborn child.

• Section 4 – FIRST AID

  Eye Contact

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

  Skin Contact

  Get medical aid immediately. Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes.

  Serious Skin Contact

  N/A

  Inhalation

  Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid.

  Ingestion

  Do not induce vomiting. Get medical aid immediately.

  Notes to Physician

  Treat symptomatically and supportively.

• 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.

  Extinguishing Media

  Use foam, dry chemical, or carbon dioxide.

• Section 6 – ACCIDENT RELEASE MEASURES

  General Information

  Use proper protective equipment as indicated in section-8.

  Spills / Leaks

  Vacuum or sweep up material and place into a suitable disposable container.

• Section 7 – HANDLING AND STORAGE

  Handling

  Do not breathe dust, vapor, mist, or gas. Do not get in eyes, on skin, or on clothing. Use only in a chemical fume hood.

  Storage

  Store in a cool, dry place. Store in a tightly closed container.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low.

  Personal Protection

  Eyes

  Wear chemical goggles.

  Skin

  Wear appropriate protective gloves to prevent skin exposure.

  Clothing

  Wear appropriate protective clothing to prevent skin exposure.

  Respirators

  Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Always use a NIOSH or European Standard EN 149 approved respirator when necessary.

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Powder

  Color

  White

  Odor

  Odorless

  pH

  7-9.5 (10% aq.sol.)

  pH (1% soln/water)

  N/A

  Vapor Pressure

  N/A

  Viscosity

  N/A

  Boiling Point

  N/A

  Boiling Point

  300 deg; C

  Auto-Ignition temperature

  N/A

  Flash Point

  N/A

  Explosion Limit, Lower

  N/A

  Decomposition temperature

  N/A

  Decomposition temperature

  N/A

  Vapour Pressure

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  Stable at Room temperature & pressure.

  Hygroscopic

  Absorbs moisture or water from the air.

  Conditions to Avoid

  Incompatible materials, exposure to moist air or water.

  Incompatibilities with Other Materials

  Oxidizing agents, bases, reducing agents.

  Hazardous Decomposition Products

  Carbon monoxide, carbon dioxide.

  Polymerization

  Has not been reported.

• Section 11 – TOXICOLOGICAL INFORMATION

  RTECS#:

  CAS#

  1069-66-5: YV7876000

  LD50/LC50

  CAS# 1069-66-5

  Oral, mouse

  LD50 = 977 mg/kg

  Oral, rabbit

  LD50 = 1468 mg/kg

  Oral, rat

  LD50 = 670 mg/kg

  Carcinogenicity

  2-Propylpentanoic acid, sodium salt -Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA. See actual entry in RTECS for complete information.

• Section 12 – ECOLOGICAL INFORMATION

  Data Not Available.

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Dispose of in a manner consistent with federal, state, and local regulations.

• Section 14 – TRANSPORT INFORMATION

  IATA

  Shipping Name

  Not regulated

  Hazard Class

  N/A

  UN Number

  N/A

  Packing Group

  N/A

  IMO

  Shipping Name

  Not regulated

  Hazard Class

  N/A

  UN Number

  N/A

  Packing Group

  N/A

  RID / ADR

  Shipping Name

  Not regulated

  Hazard Class

  N/A

  UN Number

  N/A

  Packing Group

  N/A

• Section 15 – REGULATORY INFORMATION

  European/International Regulations

  Hazard Symbols

  T

  Risk Phrases

  R 61

  May cause harm to the unborn child.

  R 22

  Harmful if swallowed

  R 36/38

  Irritating to eyes and skin

  Safety Phrases:

  S 53

  Avoid exposure – obtain special instructions before use.

  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 37/39

  Wear suitable 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).

  Canada

  None of the chemicals in this product are listed on the DSL/NDSL list. CAS# 1069-66-5 is not listed on Canada’s Ingredient Disclosure List.

  TSCA

  CAS# 1069-66-5 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.