Pheniramine Maleate (Sanofi) 25 mg Tablet is an antihistamine with a little sedative action. It is used to prevent or treat allergic reactions like hay fever or urticaria caused by pollen, dust, or animal hair. Use of this medicine in children under the age of 5 years is not recommended.

Certificate of Analysis

• Description

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

  Result

  Complies

• Solubility

  Freely soluble in water, in chloroforms & in ethanol (95%);very slightly soluble in ether.

  Result

  Complies

• Identificationn by IR

  Determine by infrared absorption spectrophotometry. Compare the spectrum with that obtained with pheniramine maleate RS or with the reference spectrum of pheniramine maleate.

  Result

  Complies

• Identificationn by Absorbance

  B. The absorbance at about 265 nm, about 0.42

  Result

  Complies

• Identification by Cooled Solutions

  A pink colour is produced which persists for at least 10 minutes in the cooled solution.

  Result

  Complies

• pH

  4.5 to 5.5, determined in a 1.0% w/v solution.

  Result

  4.70

• Related Substances by Liquid chromatography
  Any Impurity

  NMT 0.2 %

  Result

  0.048%

• Total Impurities

  NMT 1.00 %

  Result

  0.048%

• Heavy metals

  NMT 20ppm

  Result

  Complies

• Sulphated Ash

  NMT 0.1%

  Result

  0.06%

• Loss on Drying

  NMT 0.5%, determined in 1.0gram by drying in an oven at 600 C at a pressure not exceeding 0.7 kPa.

  Result

  0.22%

• Assay

  Pheniramine maleate contains not less than 99.0% & not more than 101.0% of C16H20N2,C4H4O4 calculated on dried basis.

  Result

  99.75%

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Pheniramine Maleate

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Pheniramine Maleate

  Synonym

  N,N-dimethyl-gamma-phenyl-2-pyridinepropanamine maleate

  Molecular Formula

  C16H20N2.C4H4O4

  Molecular Weight

  356.46 g/mole

  CAS Number

  132-20-7

• Section 3 – HAZARDOUS IDENTIFICATION

  Potential Actuate Health Effects

  Hazardous in case of ingestion. Slightly hazardous in case of Skin Contact (irritant), of Eye Contact (irritant), of inhalation

  Potential Chronic Health effects

  General Information

  Hazardous in case of ingestion. Slightly hazardous in case of Skin Contact (irritant), of Eye Contact (irritant), of inhalation.

  Carcinogenic Effects

  N/A

  Mutagenic Effects

  N/A

  Teratogenic effects

  N/A

  Developmental toxicity

  N/A

• Section 4 – FIRST AID

  Skin Contact

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

  Serious Skin Contact

  N/A

  Eye Contact

  No known effect on eye contact, rinse with water for a few minutes.

  Inhalation

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

  Serious Inhalation

  N/A

  Ingestion

  Do not induce vomiting. Examine the lips & mouth to ascertain whether the tissues are damaged, a possible indication that the toxic material was ingested; the absence of such signs, however, is not conclusive. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek 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), nitrogen oxides (N0,NO2…).

  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. 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. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing if ingested, seek medical advice immediately & show the container or the label.

  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 heat & 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

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

  Personal Protection In case of 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

  N/A

  Taste

  N/A

  Color

  N/A

  pH

  N/A

  Boiling Point

  Decomposes

  Melting Point

  107°C (224.6°F)

  Critical Temperature

  N/A

  Flash Point

  N/A

  Specific Gravity

  N/A

  Vapor Pressure

  N/A

  Vapor Density

  N/A

  Volatility

  N/A

  Odor Threshold

  N/A

  Ionicity (In Water)

  N/A

  Dispersion Properties

  N/A

  Solubility

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Chemical Stability

  The product is stable.

  Instability Temperature

  N/A

  Conditions of Instability

  N/A

  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

  No

• Section 11 – TOXICOLOGICAL INFORMATION

  Routes of Entry

  Ingestion

  Toxicity to Animals

  Acute oral toxicity (LD50) :268 mg/kg (Mouse)

  Chronic Effects on Humans

  N/A

  Other Toxic Effects on Human

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

  Special Remarks on Toxicity to Animal

  N/A

  Special Remarks on Chronic Effects on Humans

  N/A

  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 Biodegradation

  The products of degradation are more toxic.

  Special Remarks on the Products of Biodegradation

  N/A

• Section 13 – DISPOSAL CONSIDERATION

  Waste Disposal

  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: Pheniramine Maleate

  Other Regulations:

  OSHA

  Hazardous by definition of Hazard Communication standard (29 CFR 1910. 1200).

  Other Classifications

  WHMIS (Canada)

  CLASS D-1B: Material causing immediate & serious toxic effects (TOXIC).

  DSCL (EEC)

  R22 – Harmful if swallowed.

  HMIS (U.S.A):

  Health Hazard

  2

  Fire Hazard

  1

  Reactivity

  0

  Personal Protection

  E

  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.