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%
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Material Safety Data Sheet
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Section 1 – Chemical Product
Product Identifier
Dexchlorpheniramine Maleate
MSDS Prepared By
R&D Department
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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
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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.
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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
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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
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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.
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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.
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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
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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.
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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
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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
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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
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Section 13 – DISPOSAL CONSIDERATION
No data Available.
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Section 14 – TRANSPORT INFORMATION
DOT Classification
N/A
Identification
N/A
Special Provisions for Transport
N/A
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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.
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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.