Pheniramine Maleate

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.

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