Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Diphenhydramine is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson’s disease.

Diphenhydramine may also be used for purposes not listed in this medication guide.

 

Certificate of Analysis

• Description

  A White or almost white, crystalline powder; odourless or almost odourless.

  Result

  Complies

• Solubility

  Very soluble in water, freely soluble in chloroform and in ethanol (95%) practically insoluble in either.

  Result

  Complies

• Identification by IR

  Determine by Infrared Absorption spectrophotometry.

  Result

  Complies

• Identification by Chlorides

  Gives the reaction of Chlorides.

  Result

  Complies

• Appearance Of Solutions

  A 5% w/v solution in carbon dioxide – free water and a 5-fold dilution, thereof, are both clear. The 5% solution is not more intensely coloured than reference solutions BYS6.

  Result

  Complies

• pH

  4.0 to 6.0, determined in a 5% w/v solution.

  Result

  4.50

• Related Substance Determined by Liquid Chromatography
  Impurity A

  NMT 0.5%

  Result

  0.117%

• Any Other Impurity

  NMT 0.3%

  Result

  0.021%

• Total Impurity

  NMT 1.0%

  Result

  0.189%

• Sulphated Ash

  NMT 0.1%

  Result

  0.07%

• Loss on Dying

  NMT 0.5%, determined on 1.0 g by drying in an oven at 1050

  Result

  0.22%

• Assay

  Diphenhydramine HCL contains not less than 99.0% & NMT 101% of C17H21NO,HCL calculated on the dried basis.

  Result

  99.74%

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Diphenhydramine HCl

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Diphenhydramine HCl

  Synonym

  2-(Diphenymethoxy)-N,N-dimethylethylamine hydrochloride

  Molecular Formula

  C17H2NO.HCl

  Molecular Weight

  291.85 g/mole

  CAS Number

  147-24-0

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Acute Health Effects

  Extremely hazardous in case of eye contact (irritant). Very hazardous in case of ingestion, of inhalation. Hazardous in case of skin contact (irritant). Inflammation of the eye is characterized by redness, watering and itching. Severe over-exposure can result in death.

  Potential Chronic Health Effects

  Carcinogenic Effects

  Classified 2 (Reasonably anticipated.) by NTP

  Mutagenic Effects

  N/A

  Teratogenic Effects

  N/A

  Developmental Toxicity

  N/A. The substance is toxic to lungs, mucous membranes. Repeated or prolonged exposure to the substance can produce target organs damage.

• Section 4 – FIRST AID

  Eye Contact

  Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention.

  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. Cold water may be used. 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.

  Inhalation

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

  Serious Inhalation

  N/A

  Ingestion

  Do not induce vomiting. Loosen 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.

  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 oxides (CO, CO2), sulphur oxides (SO2, SO3…).

  Fire Hazards in Presence of Various Substances

  N/A

  Explosion Hazards in Presence of Various Substances

  Risks of explosion of the product in presence of mechanical impact

  N/A

  Risks of explosion of the product in presence of static discharge

  N/A

  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

  N/A

  Special Remarks on Explosion Hazards

  N/A

• Section 6 – ACCIDENT RELEASE MEASURES

  Small Spill

  Use appropriate tools to put the spilled solid in a convenient waste disposal container.

  Large Spill

  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

  Precaution

  Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. In case of insufficient ventilation, wear suitable respiratory equipment 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. Carcinogenic, teratogenic or mutagenic materials should be stored in a separate locked safety storage cabinet or room.

• 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 Precautions

  Safety glasses. Lab coat.

  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 and appearance

  Solid

  Odor

  Odorless

  Taste

  N/A

  Colour

  N/A

  pH (1% soln/water)

  N/A

  Boiling Point

  N/A

  Melting Point

  168°C (334.4°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

  Iconicity (in Water)

  N/A

  Dispersion Properties

  See solubility in water.

  Solubility

  Soluble in cold water, hot water.

• Section 10 – STABILITY AND REACTIVITY

  Stability

  The Product is stable.

  Instability Temperate

  N/A

  Condition of Instability

  N/A

  Incompatibility with Various Substance

  Reactive with oxidizing agents.

  Corrosivity

  N/A

  Special Remarks on Reactivity

  N/A

  Special Remarks on Corrosivity

  N/A

  Polymerization

  No

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Eye Contact. Inhalation. Ingestion.

  Toxicity to Animals

  Acute Oral Toxicity LD50

  N/A

  Acute Oral Toxicity LC50

  N/A

  Chronic Effects on Humans

  Carcinogenic Effects

  Classified 2 (Reasonably anticipated.) by NTP. The substance is toxic to lungs, mucous membranes.

  Other Toxic Effects on Humans

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

  Special Remarks on Toxicity to Animals

  N/A

  Special Remarks on Chronic Effects to Human

  Embryotoxic and/or fetotoxic in animal.

  Special Remarks on other Toxic Effects on Human

  N/A

• Section 12 – ECOLOGICAL INFORMATION

  Ecotoxicity

  N/A

  BOD5 & 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 more toxic.

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  No data Available.

• 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

  TSCA 8(b) Inventory

  No products were found.

  Other Regulations

  OSHA

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

  Other Classifications

  WHMIS (Canada)

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

  DSCL (EEC)

  R38

  Irritating to skin.

  R41

  Risk of serious damage to eyes.

  R45

  May cause cancer.

  HMIS (U.S.A):

  Health Hazard

  3

  Fire Hazard

  1

  Reactivity

  0

  Personal Protection

  E

  U.S.A. :

  Health

  3

  Flammability

  1

  Reactivity

  0

  Specific hazard

  N/A

  Protective Equipment

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

• 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.