Chlorpheniramine Maleate
Chlorphenamine (also known as chlorpheniramine, CP, or CPM) is a first-generation antihistamine used in the prevention of the symptoms of allergic conditions such as rhinitis and urticaria. Its sedative effects are relatively weak compared to other first-generation antihistamines. Chlorphenamine is one of the most commonly used antihistamines in small-animal veterinary practice. Although not generally approved as an antidepressant or anti-anxiety medication, chlorphenamine appears to have these properties as well.
Certificate of Analysis
- Appearance
White or almost white, Crystalline powder.
Result
Complies
- Solubility
Freely soluble in water, soluble in ethanol (96%).
Result
Complies
- Identification
A. Melting point : 1300 °C to °1350 C
Result
1310 °C to 1320 °C
- Identification
B. Infrared absorption spectrophotometry. Comparison : chlorphenamine maleate CRS.
Result
Complies
- Identification
C. Optical rotation : (see test)
Result
Complies
- Solutions
NMT 0.05%
Result
0.02%
- UV 1%,1 cm, 222nm
Dissolve 2.0g in water & dilute to 20 ml with the same solvent.
Result
Complies
- Appearance of Soln.
Solution S is clear & not more than intensely coloured than reference solution BY6.
Result
Complies
- Optical Rotation
-0.100° to + 0.100°, determined on solution S.
Result
0°
- Related Substances
Impurity ANMT 0.2%
Result
0.022%
- Impurity B
NMT 0.1%
Result
0.046%
- Impurity C
NMT 0.1%
Result
0.044%
- Impurity D
NMT 0.1%
Result
Not detected
- Unspecified Impurities
NMT 0.1%
Result
0.015%
- Total Impurities
NMT 0.5%
Result
0.127%
- Heavy Metals
Maximum 20 ppm
Result
Complies
- Loss on Drying
Maximum 0.5%, determined on 1.000 g by drying in an oven at 1050 C for 4 hrs.
Result
0.24%
- Sulphated Ash
Maximum 0.1%, determined on 1.0 g.
Result
0.06%
- Assay
98.0 % to 101.0% (dried substance).
Result
99.61%
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Material Safety Data Sheet
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Section 1 – Chemical Product
Product Identifier
Chlorpheniramine Maleate
MSDS Prepared By
R&D Department
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Section 2 – Composition / Information Of Ingredients
Product Name
Chlorpheniramine Maleate
Synonym
2-(p-chloro-alpha-(2-(diethylamino) ethyl) benzyl) pyridine maleate
Molecular Formula
C20H23CLN2O4
Molecular Weight
390.9 g/mole
CAS Number
113-92-8
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Section 3 – HAZARDOUS IDENTIFICATION
Potential Acute Health Effects
Very hazardous in case of Ingestion. Hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation. Slightly hazardous in case of skin contact (permeator).
Potential Chronic Health Effects
Carcinogenic Effects
N/A
Mutagenic Effects
N/A
Teratogenic Effects
N/A
Developmental Toxicity
N/A. Repeated or prolonged exposure is not known aggravate medical condition.
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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
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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…).
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. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
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.
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Section 7 – HANDLING AND STORAGE
Precaution
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. Wear suitable protective clothing. 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. Keep container tightly closed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizing agents.
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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. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
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
Odor
N/A
Taste
N/A
Colour
N/A
pH (1% soln/water)
N/A
Boiling Point
N/A
Melting Point
132.5°C (270.5°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
N/A
Acute Oral Toxicity LC50
N/A
Chronic Effects on Humans
N/A
Other Toxic Effects on Humans
Very hazardous in case of Ingestion. Hazardous in case of skin contact (irritant), of eye contact (irritant), of inhalation. Slightly hazardous in case of skin contact (permeator).
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 product itself and its products of degradation are not 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
Not a DOT controlled material (US).
Identification
N/A
Special Provisions for Transport
N/A
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Section 15 – REGULATORY INFORMATION
Federal and State Regulations
TSCA 8 (b) Inventory
Chlorpheniramine maleate
Other Regulations
N/A
Other Classifications
WHMIS (Canada)
Not controlled under WHMIS (Canada).
DSCL (EEC)
R36/38
Irritating to eyes and skin.
HMIS (U.S.A):
Health Hazard
2
Fire Hazard
1
Reactivity
0
Personal Protection
E
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.