Econazole Nitrate

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.

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