Dexchlorpheniramine Maleate

Dexchlorpheniramine competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. Dexchlorpheniramine is the predominant active isomer of chlorpheniramine and is approximately twice as active as the racemic compound (Moreno 2010).

Certificate of Analysis

  • Description

    A White almost white, crystalline powder.

    Result

    Complies

  • Solubility

    Very soluble in water, freely soluble in ethanol (95%) in menthol and in dichloromethane.

    Result

    Complies

  • Identification by IR

    Determine by Infrared Absorption spectrophotometry. Compare the spectrum with the obtained with Dexchlorpheniramine Maleate RS or with the reference spectrum of Dexchlorpheniramine Maleate.

    Result

    Complies

  • Appearance of Solutions

    A 10% w/v solution in water (solution A) is clear and not more intensely coloured then reference solutions BYS6.

    Result

    Complies

  • pH

    4.5 to 5.5 determined in a 1% w/v solution in water.

    Result

    4.73

  • Specific Optical Rotation

    +220° to +230°, determined in Solution A.

    Result

    +22.70°

  • Related Substances Determined by Gas Chromatography.

    Any Impurity

    NMT 0.4%

    Result

    0.23%

  • Total Impurity

    NMT 1.0%

    Result

    0.23%

  • Enantiomeric Purity Determined by Liquid Chromatography.

    (R)-Enantiomer

    NMT 2.0%

    Result

    Complies

  • Any Impurity

    NMT 0.5%

    Result

    Complies

  • Heavy Metals

    NMT 20 PPM

    Result

    Complies

  • Loss on Drying

    NMT 0.5%, determined on 1.0 g by drying in vacuum over at 650 for 4 hours

    Result

    0.20%

  • Sulphated Ash

    NMT 0.1%

    Result

    0.05%

  • Assay

    Dexchlorpheniramine Maleate contains not less than 98.0% & NMT 100.5% of C16H19CIN2, C4H4O4 calculations on the dried basis.

    Result

    99.82%

Note: Note: – We are leading channel partner of much API manufacturer, supplier & exporters and Pharmaceutical raw material in Colombo, Chili, Ecuador and Globally.

Material Safety Data Sheet

  • Section 1 – Chemical Product

    Product Identifier

    Dexchlorpheniramine Maleate

    MSDS Prepared By

    R&D Department

  • Section 2 – Composition / Information Of Ingredients

    Product Name

    Dexchlorpheniramine Maleate

    Synonym

    2-(p-chloro-alpha-(2-(diethylamino)ethyl) benzyl) pyridine maleate

    Molecular Formula

    C16H19ClN2.C4H4O4

    Molecular Weight

    390.87 g/mole

    CAS Number

    2438-32-6

  • Section 3 – HAZARDOUS IDENTIFICATION

    Potential Acute Health Effects

    Very hazardous in case of ingestion. Hazardous in case of inhalation. Slightly hazardous in case of eye contact (irritant). Severe over-exposure can result in death.

    Potential Chronic Health Effects

    Carcinogenic Effects

    N/A

    Mutagenic Effects

    N/A

    Teratogenic Effects

    N/A

    Developmental Toxicity

    N/A. Repeated exposure to an highly toxic material may produce general deterioration of health by an accumulation in one or many human organs.

  • Section 4 – FIRST AID

    Eye Contact

    Immediately flush eyes with running water for at least 15 minutes. Keeping eyelids open. Cold water may be used.

    Skin Contact

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

    Serious Skin Contact

    N/A

    Inhalation

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

    Serious Inhalation

    Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention.

    Ingestion

    Do not induce vomiting. Examine the lips and 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 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…) halogenated compounds.

    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.

  • Section 7 – HANDLING AND STORAGE

    Precaution

    Keep locked up 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 In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and 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. High toxic or infectious 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 (Solid crystalline Powder)

    Odor

    Odorless

    Taste

    N/A

    Colour

    N/A

    pH (1% soln/water)

    N/A

    Boiling Point

    N/A

    Melting Point

    114°C (237.2°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.

  • 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

    189 mg/kg [Mouse].

    Chronic Effects on Humans

    N/A

    Other Toxic Effects on Humans

    Very hazardous in case of ingestion. Hazardous in case of inhalation.

    Special Remarks on Toxicity to Animals

    N/A

    Special Remarks on Chronic Effects to Human

    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 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

    N/A

    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 communication Standard (29 CFR 1910.1200).

    Other Classifications

    WHMIS (Canada)

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

    DSCL (EEC)

    R22

    Harmful if swallowed.

    HMIS (U.S.A):

    Health Hazard

    2

    Fire Hazard

    1

    Reactivity

    0

    Personal Protection

    a

    U.S.A. :

    Health

    2

    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.

WhatsApp
+91 9819994077