Microsoft word - citalopram hydrobromide oral solution.doc

Page 1 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL
IN CASE OF EMERGENCY
Emergency Phone: (614) 276-4000
Material Safety Data Sheet
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Common/Trade Name: Citalopram Hydrobromide Oral Solution 10 mg/ 5 mL
Chemical Name: 1-(3-dimethylaminopropyl)-1-(p-fluoropheny)-5-phthalancarbonitrile hydrobromide
Synonyms: None
Molecular Formula: C20H22BrFN2O
Molecular Weight: 405.35
CAS No: 59729-32-7
Chemical Family: Selective serotonin reuptake inhibitor (SSRI)
Product Use: Antidepressant
Manufacturer’s Name: Boehringer Ingelheim Roxane Inc.
Address: 1809 Wilson Road
Columbus, Ohio 43228
2. COMPOSITION / INFORMATION ON INGREDIENTS
Composition CAS#
Exposure
Citalopram Hydrobromide (active ingredient) 59729-32-7
established
REFER to PHYSICIAN’S DESK REFERENCE for common components present as <1%
3. HAZARDS IDENTIFICATION
Emergency
Physical State: Liquid solution administered orally.
Overview
Peppermint flavored oral solution with 10 mg/5 mL active ingredient.
Odor: None
WARNING!
May be harmful if swallowed.
Accidental ingestion of large amounts may be fatal.
Primary Route(s)
Ingestion
Potential Health
Inhalation: Not expected to be an inhalation hazard in final pharmaceutical form.
Effects:
Eye Contact: Not expected to be a hazard to the eye. Contact with eye may cause irritation,
burning and redness.
Skin Contact: Not expected to be a hazard to the skin. Can cause hypersensitive reactions
resulting in rash, redness, itching and inflammation.
Ingestion: May be harmful if ingested. Ingestion may cause headache, nausea, dizziness,
fatigue, and fast heartbeat.
Toxicity Data:
See Section 11
Effects of
The potential for exposure is reduced in finished pharmaceutical form.
Overexposure:
Overexposure by ingestion may cause nausea, headache, oedema and heart palpitations.
Target Organs:
Brain, Central Nervous System
4. FIRST AID MEASURES
Eye Exposure
Any material that contacts the eye should be washed out immediately with water. If easy to do,
remove contact lenses if worn. Get medical attention if symptoms persist.
Skin Exposure
Wash with soap and water. Get medical attention if symptoms occur.
Page 2 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL
Ingestion
Call a physician or poison control center immediately.
Inhalation
Should not pose a hazard in the final form. If breathing is difficult, move to fresh air. Get
medical attention immediately.
5. FIRE AND EXPLOSION HAZARDS
Flammability
Lower: N/A Upper: N/A
Flash Point
Not available
Extinguishing Media
Use water spray, carbon dioxide, dry chemical, foam or material appropriate for fire
in surrounding area.
Special Fire Fighting
Procedures
Wear full protective clothing and self-contained breathing apparatus.
Unusual Fire/Explosion
Not Applicable
Hazardous Combustion
Products
Carbon dioxide, carbon monoxide, oxides of nitrogen, hydrogen bromide,
hydrogen fluoride
6. ACCIDENTAL RELEASE INFORMATION
STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF LIQUID IS SPILLED:
Use appropriate personal protective equipment (see Section 8). Wipe up and containerize spill material in a
compatible container. Dispose according to applicable regulations. Incineration of the waste at an approved facility
is recommended.
7. PRECAUTIONS FOR SAFE HANDLING AND USE
Precautions Handling
Observe good industrial hygiene practices.
Significant Quantities
of Liquid:
Storage
Store at 20° to 25°C (68° to 77°F). Keep container closed tightly. Protect from light and
moisture. Store away from foodstuffs.
8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Exposure Limits
Engineering Controls
Not required when handling liquid or containers. Good ventilation should be used.
Ventilation should be matched to conditions.
Respiratory
Not required when handling liquid or containers. NIOSH/MSHA approved respirators for
Protection
protection should be used if respirators are found to be necessary. Ventilation should be
matched to conditions.
Personal Protection
Not required when handling final product. If containers are compromised or exposure is
likely wear: Goggles, Lab Coat, Gloves
Recommended
Facilities
Eye wash, washing facilities
9. PHYSICAL / CHEMICAL CHARACTERISTICS
Appearance Oral
solution
Not available
Solubility in
Boiling point
Not available
Specific Gravity
Not available
Taste Peppermint
Pressure
available Flashpoint
available
available
Not available
Flammability
Not available
10. STABILITY AND REACTIVITY DATA
Stability Stable
Incompatibility None
Hazardous
Decomposition
Oxides of carbon, oxides of nitrogen, hydrogen bromide, hydrogen fluoride
Conditions to
Excessive heat and light
Page 3 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL
Hazardous
Polymerization
Will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity:
Active Ingredient:
LD50 Oral (rat): approximately 800 mg/kg
Carcinogenicity: Not listed as a carcinogen by NTP, IARC Monographs or OSHA.
12. ENVIRONMENTAL IMPACT INFORMATION
No information is currently available on the environmental impact of this product.
13. DISPOSAL INFORMATION
Waste Disposal Considerations: Dispose of material according to federal, state and local disposal regulations or
company operating procedures. Disposal by incineration is recommended.
At home: Discard away from children’s reach.
14. TRANSPORTATION INFORMATION
This product is not subject to the regulations for the safe transport of hazardous chemicals.
DOT: Not regulated
TDG: Not regulated
IATA: Not regulated
IMDG: Not regulated
15. REGULATORY INFORMATION

DEA: Citalopram Hydrobromide is not a controlled substance.
FDA: Citalopram Hydrobromide is an approved prescription medication.
Inventory Status:
This material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt purposes such
as R&D or drug use.
This material is not listed on the DSL Inventory but is exempt.
16. OTHER DATA
ABBEVIATIONS:
N/A – not applicable
Prepared by: Boehringer Ingelheim Roxane Inc.
References:
1. Citalopram Hydrobromide Oral Solution, Package Insert, Boehringer Ingelheim Roxane Inc., Columbus, Ohio
2. RTECS No. NP6406750 for 5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-
dihydro-,monohydrobromide
3. Ariel Webinsight. Regulatory and ChemExpert Database.
4. PDR – Physicians Desk Reference
Date: 09/13/2008 - New MSDS
SEE CURRENT PACKAGE INSERT FOR FURTHER INFORMATION
The information provided is believed to be complete and accurate. If this product is combined with other materials, deteriorates or
becomes contaminated, it may pose hazards not mentioned in this MSDS. It is the users’ responsibility to use the information
according to the application. Boehringer Ingelheim Roxane Inc. assumes no responsibility or liability resulting from the use of this
information.

Source: http://bi-msds.e3solutionsinc.com/CITALOPRAM%20HYDROBROMIDE%20OS.pdf