Econazole (commonly used as the nitrate salt) is an antifungal medication of the imidazole class.It is sold under the brand names Spectrazole (United States) and Ecostatin (Canada), among others. It is a component of Pevisone and Ecoderm-TA (econazole/triamcinolone).

Certificate of Analysis

• Appearance

  White or almost white , crystalline powder

  Result

  Complies

• Solubility

  Very slightly soluble in water, soluble in methanol, sparingly soluble in methylene chloride, slightly soluble in ethanol (96%)

  Result

  Complies

• Melting Point

  About 165° C, with decomposition.

  Result

  163° C

• Identification by IR

  Infrared absorption spectrophotometry. Comparison: econazole nitrate CRS.

  Result

  Complies

• Related Substance
  Impurities A,B,C

  NMT 0.2 %

  Result

  Not detected

• Related Substance
  Unspecified impurities

  NMT 0.1 %

  Result

  0.038%

• Related Substance
  Total Impurities

  NMT 0.3 %

  Result

  0.078%

• Loss on drying

  Maximum 0.5%, determined on 1.000g by drying in an oven at 105° C for 4 h.

  Result

  0.21 %

• Sulphated ash

  Maximum 0.1 %, determined on 1.0 g

  Result

  0.05 %

• Assay

  99.0 % to 101.0 % (dried substance)

  Result

  99.67 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Econazole Nitrate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Econazole Nitrate

  Synonym

  1-[2—[4-Chlorophenyl) methoxyl] -2- (2,4-dichlorophenyl) ethyl] -1H-imidazole mononitrate

  Molecular Formula

  C18H15Cl3N2O.HNO3

  Molecular Weight

  440.7 g/mole

  CAS Number

  69797-31-9

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Acute Health Effects

  Hazardous in case of skin contact, eye contact, of ingestion. Slightly hazardous in case of inhalations.

  Potential Chronic Health Effects

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Teratogenic Effects

  N/A

• Section 4 – FIRST AID

  Skin Contact

  After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing.

  Serious Skin Contact

  Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention.

  Eye Contact

  Check for and remove any contact lenses. Immediately flush eyes with running water for at least 25 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention.

  Inhalation

  Allow the victim to rest in a well ventilated area. Seek immediate medical attention.

  Ingestion

  Do not induce vomiting. Loosed tight clothing such as a collar, tie belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of the Product

  May be combustible at high temperature.

  Auto-ignition Temperature

  N/A

  Flash Point

  N/A

  Flammable Limits

  N/A

  Products of Combustion

  These products are carbon oxide, nitrogen oxides, halogenated compounds.

  Fire Hazards in presence of various substance

  N/A

  Explosion hazards in presence of various substance

  Risks of explosion of the product in presence of mechanical impact

  N/A

  Risks of explosion of product in presence of static discharge

  N/A

  Fire Fighting Media & Instruction

  Small Fire

  Use DRY chemical powder.

  Large Fire

  Use water spray, fog or foam. Do not use water jet.

  Special Remarks on Fire Hazard

  N/A

  Special Remarks on Explosion Hazard

  N/A

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spill

  Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spading water on the contaminated surface and dispose of according to local and regional authority requirements.

  Large Spill

  Use a shovel to out the material into a convenient waste disposal container. Finish cleaning by spading water on the contaminated surface and allow to evacuate through the sanitary system.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Keep way from heat. Keep away from source of ignition. Empty containers pose a fire risk, evaporate the reside under a fume hood. Ground all equipment containing material. Do not breathe dust. Wear suitable protective clothing if you feel unwell, seek medical attention and show the label when possible. Avoid contact with skin and Eyes.

  Storage

  Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme head and away from strong oxidizing agents.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

  Personal Protection

  Splash googles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloved.

  Personal Protection in case of large spills

  Splash googles. Lab coat. Dust respirator. A self-contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

  Exposure Limits

  N/A

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Physical State

  Solid

  Odor

  N/A

  Taste

  N/A

  Colour

  White

  pH (1% soln/water)

  N/A

  Boiling Point

  N/A

  Melting Pointy

  323.6 ° F

  Critical Temperature

  N/A

  Specific Gravity

  N/A

  Vapour Pressure

  N/A

  Vapour Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Water / Oil Dist. Coeff

  N/A

  Iconicity (in water)

  N/A

  Dispersion Properties

  N/A

  Solubility

  Very slightly soluble in cold water.

• Section 10 – STABILITY AND REACTIVITY

  Stability

  The Product is stable.

  Instability Temperature

  N/A

  Condition of Instability

  N/A

  Incompatibility with various substance

  Not known

  Corrosivity

  Non-corrosive in presence if glass.

  Special Remarks on Corrosivity

  N/A

  Special Remarks on Reactivity

  N/A

  Polymerization

  N/A

• Section 11 – TOXICOLOGICAL INFORMATION

  Route of Entry

  Eye Contact. Ingestion

  Toxicity to Animals

  LD50

  N/A

  LC50

  N/A

  Chronic Effects on Humans

  N/A

  Other Toxic Effects on Humans

  Hazardous in case of skin contact, of ingestion. Slightly hazardous in case of inhalation.

  Special Remarks on Toxicity to Animals

  N/A

  Special Remarks on chronic Effects on Humans

  N/A

  Special Remarks on other Toxicity effects to Humans

  N/A

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 and COD

  N/A

  Products of Biodegradation

  Possibly hazardous short term degradation products are likely. However, long term degradation products may arise.

  Toxicity of the products Biodegradation

  The products of degradation are more toxic.

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  Waste must be disposed of it in accordance with federal, state and local environmental control regulations.

• Section 14 – TRANSPORT INFORMATION

  DOT Classification

  Not a DOT controlled material (US).

  Identification

  N/a

  Special provision for Transports

  N/A

• Section 15 – REGULATORY INFORMATION

  Federal and State Regulations

  TSCA 8(b) inventory

  No products were found.

  Other Regulations

  N/A

  Other Classifications

  WHMIS (Canada)

  Not controlled under WHMIS (Canada).

  DSCL (EEC)

  R36/38 irritating to eyes and skin.

  HMIS (U.S.A)

  Health Hazard

  2

  Fire Hazard

  1

  Reactivity

  0

  Personal Protection

  E

  National Fire Protection Association (U.S.A)

  Health

  2

  Flammability

  1

  Reactivity

  0

  Protective Equipment

  Gloves coat. Dust respirator. Be sure to use an approved / certified respirator or equivalent. Splash goggles.

• 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.