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

  White to pale cream powder,may exhibits polymorphism.

  Result

  Complies

• Solubility

  Insoluble in water; soluble in ether; freely soluble in alcohol, in methanol, in isopropyl alcohol, in acetone, in propylene glycol, in chloroform, & in dimethylformamide.

  Result

  Complies

• Melting Point

  Melts in the range of 78° to 88 °.

  Result

  83° to 84°

• Identification By IR

  Infrared Absorption. Compare the spectrum with that obtained with Miconazole RS.

  Result

  Complies

• Identification By UV

  The UV absorption spectrum of his solution exhibits maxima & minima at the same wavelengths as that of a similar solution of USP Miconazole RS, concomitantly measured.

  Result

  Complies

• Assay

  Miconazole contains not less than 98.0 % & not more than 102.0 % of C18H14C14N2O, calculated on the dried basis.

  Result

  99.55 %

• Residue on Ignition

  NMT 2.0%

  Result

  0.06%

• Organic Impurities

  Determine by thin-layer chromatography.

  Result

  Complies

• Loss on drying

  Dry it in vacuum at 60° for 4 hours : it loses not more than 0.5 % of its weight.

  Result

  0.28 %

• Residual Solvents
  Benzene

  Not more than 2 ppm

  Result

  Not detected

• Residual Solvents
  Methanol

  Not more than 3000 ppm

  Result

  Not detected

• Residual Solvents
  Toluene

  Not more than 890 ppm

  Result

  Not detected

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Miconazole Base

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Miconazole Base

  Synonym

  1H- Imidazole, 1-(2-(2,4-dichlorophenyl) -2- ((2-4-dichlorophenyl) methoxy) ethyl)-; Imidazole, 1-(20(2,4- dichlorophenyl) -2-((2,4- dichlorophenyl)methoxy) ethyl)

  Molecular Formula

  C18H14Cl4N2O

  Molecular Weight

  416.13 g/mole

  CAS Number

  22916-47-8

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Acute Health Effects:

  Slightly hazardous in case of skin contact, of eye contact, 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 & remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. 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

  N/A

  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.

  Slightly explosive in presence of open flames and sparks. No-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.

• Section 7 – HANDLING AND STORAGE

  Precautions

  Keep away from heat. Keep away from sources of ignition. Do not ingest. Do not breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or the label.

  Storage

  Keep container tightly closed. Keep container in a cool, well-ventilated area.

• 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

  Odor

  Odorless

  Taste

  Bitter

  Colour

  White. Off-White

  pH

  N/A

  Boiling Point

  Decomposes

  Melting Point

  170°C

  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

  See solubility in water, acetone.

  Solubility

  Easily soluble in acetone. Insoluble in cold water, hot water. Soluble in Dimethylformamide.

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  The product is stable.

  Instability Temperature

  N/A

  Condition of Instability

  Excess heat, incompatible materials.

  Incompatibility with various substances

  N/A

  Corrosivity

  Non-corrosive in presence of glass.

  Special Remarks on Reactivity

  N/A

  Special Remarks on Corrosivity

  N/A

  Polymerization

  Will not occur.

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Inhalation. Ingestion.

  Toxicity to Animals

  Acute oral toxicity

  Chronic Effects on Humans

  The substance is toxic to the nervous system.

  Other Toxic Effects on Humans

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

  Special Remarks on Chronic Effects on Humans

  May affect genetic material. May cause adverse reproductive effects. Based in animal test data.

  Acute Potential Health Effects

  Skin

  May cause irritation. May cause allergic reactions such as itching, rash, cutaneous pruritus, flushes.

  Eyes

  May cause irritation.

  Inhalation

  May cause respiratory tract irritation.

  Ingestion

  May cause gastrointestinal tract irritation or upset with nausea, vomiting, diarrhea, anorexia. May affect the cardiovascular system, blood, behavior, central nervous system, respiration. It may also cause hyperlipidemia, febrile reactions, arthralgia and anaphylaxis.

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 and COD

  N/A

  Products of Biodegradation

  Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

  Toxicity of the Products of Biodegradation

  The products of degradation are as toxic as the product itself.

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

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

• Section 14 – TRANSPORT INFORMATION

  DOT Classification

  Not a DOT controlled material (United States).

  Identification

  N/A

  Special Provisions for Transport

  N/A

• Section 15 – REGULATORY INFORMATION

  Federal and State Regulations

  No products were found

  Other Regulations:

  OSHA

  Hazardous by definition of Hazard Communications Standard (29 CFR 1910.1200).

  EINECS

  This product is on the European Inventory of Existing Commercial Chemical Substances.

  Other Classifications

  WHMIS (Canada)

  CLASS D-2B: Material causing other toxic effects (TOXIC).

  DSCL (EEC)

  R22

  Harmful if swallowed.

  S2

  Keep out of the reach children.

  S46

  If swallowed, seek medical advice immediately and show this container or label.

  HMIS (U.S.A)

  Health Hazard

  1

  Fire Hazard

  1

  Reactivity

  0

  Personal Protection

  E

  National Fire Protection Association (U.S.A)

  Health

  1

  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.