Miconazole is an antifungal medication that fights infections caused by fungus.

Miconazole buccal is used to treat candida (yeast) infections inside the mouth.

Miconazole buccal may also be used for purposes other than those listed in this medication guide.

Certificate of Analysis

• Description

  A White or Almost White, Crystalline or Micro Crystalline Powder.

  Result

  A White Micro crystalline Powder.

• Solubility

  Sparingly soluble in methanol; Slightly soluble in ethanol (95%) and in Chloroform; very slightly Soluble in water and in ether. (2,4,26)

  Result

  Complies.

• Identification

  Infra-red absorption spectrum (2,4,6)

  Result

  Complies.

• Appearance of solution

  1 % w/v solution in methanol is clear and not more intensely colored than reference solution YS7 (2,4,1)

  Result

  Complies.

• Related Substances

  By thin layer chromatography (2,4,17)

  Result

  Complies.

• Sulphated Ash

  Not more than 0.1 % (2,3,18)

  Result

  0.026 %

• Loss on drying

  Not more than 0.5 %, determined on 1 gm by Drying in an oven at 105° C for 2hrs. (2,4,19)

  Result

  0.31 %

• Assay ( By potentiometrically)

  Miconazole Nitrate contains NLT 98.5 % & NMT 101.5 % of C18H14CI4N2O,HNO3, Calculated on the dried basis. (2,4,25)

  Result

  99.525 %

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Miconazole Nitrate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Miconazole Nitrate

  Synonym

  1-(2,4-Dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)-imidazole nitrate; (+-)-Miconazole nitrate; 1H-Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-,mononitrate; Monistat

  Molecular Formula

  C18-H14-Cl4-N2-O.HNO3

  Molecular Weight

  479.14 g/mole

  CAS Number

  22832-87-7 100

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Acute Health Effects:

  Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.

  Potential Chronic Health Effects

  Very hazardous in case of skin contact (irritant), of ingestion, of inhalation. Hazardous in case of eye contact (irritant).

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Developmental Toxicity

  N/A

• Section 4 – FIRST AID

  Skin Contact

  Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.

  Serious Skin Contact

  N/A

  Eye Contact

  Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. WARM water MUST be used. Get medical attention if irritation occurs.

  Inhalation

  If inhaled remove to fresh Air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear.

  Serious Inhalation

  N/A

  Ingestion

  Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or wristband.

  Serious Ingestion

  N/A

• Section 5 – FIRE FIGHTING MEASURES

  Flammability of the Product

  May be combustible at high temperature.

  Auto-ignition Temperature

  350°C (662°F)

  Flash Points

  N/A

  Flammable Limits

  N/A

  Products of Combustion

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

  Fire Hazards in Presence of Various Substances

  Slightly flammable to flammable in presence of heat. Non-explosive in presence of shocks.

  Fire Fighting Media and Instructions

  Small Fire

  Use DRY chemical powder.

  Large Fire

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

  Special Remarks on Fire Hazards

  As with most organic solids, fire is possible at elevated temperatures.

  Special Remarks on Explosion Hazards

  Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is potential dust explosion hazard.

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spills

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

  Large Spills

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

  Methods & Materials for containment & Cleaning up

  Pick up and arrange disposal without creating dust. Keep in suitable, closed containers for disposal.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, alkalis.

  Storage

  Keep container tightly closed. Keep container in a cool, well-ventilated area. Sensitive to light. Store in light-resistant containers.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

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

  Personal Protection

  Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.

  Personal Protection in Case of a Large Spill

  Splash goggles. Full suit. Dust respirator. Boots. Gloves. 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 Crystalline powder

  Odor

  N/A

  Taste

  N/A

  Colour

  White

  pH (1% soln/water)

  N/A

  Boiling Point

  N/A

  Melting Point

  170.5°C (338.9°F)

  Critical Temperature

  N/A

  Specific Gravity

  N/A

  Vapor Pressure

  N/A

  Vapor Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Water/Oil Dist. Coeff

  N/A

  Ionicity (in Water)

  N/A

  Dispersion Properties

  N/A

  Solubility

  Very slightly soluble in cold water.

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  The product is stable.

  Instability Temperature

  N/A

  Condition of Instability

  Excess heat, light, dust generation, incompatible materials.

  Incompatibility with various