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MSDS Material Safety Data Sheet
CAS

41183-64-6
7647-14-5
100-51-6
6132-04-3
7732-18-5

File Name: imaging_mallinckrodt_com---Gallium_Citrate.asp
                          MATERIAL SAFETY DATA SHEET
GALLIUM CITRATE Ga 67 INJECTION

SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: Gallium Citrate Ga 67 Injection Revision Date: January 1, 2003
Synonyms: Gallium 67; Gallium Citrate Ga 67 Information Telephone Number: (888) 744-1414
Manufacturer: Mallinckrodt Inc. Emergency Telephone Number: (314) 654-7860
2703 Wagner Place CHEMTREC: 1-800-424-9300
Maryland Heights, MO 63043 CANUTEC: 613-996-6666

SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS
Chemical Ingredients:
Component CAS # Wt %
Gallium Citrate Ga 67 41183-64-6 < 0.001%
Sodium Chloride 7647-14-5 < 1%
Benzyl Alcohol 100-51-6 < 1%
Sodium Citrate 6132-04-3 < 1%
Water 7732-18-5 > 99%



SECTION 3. HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
CAUTION! RADIOACTIVE MATERIAL. Read Package Insert prior to use. Promptly remove any
contamination from the skin, eyes, or clothing. Radioactive drugs must be handled by qualified personnel
in conformity with regulations appropriate to the government agency authorized to license the use of this
radionuclide. The vial containing the drug should be kept within its container or within heavier shielding.
Avoid contact with the radioactive contents which would cause unnecessary exposure to radiation.

POTENTIAL HEALTH EFFECTS
Eye Contact:
Inhalation:
No adverse effect expected, but may cause
Gallium Citrate does not easily become
mechanical irritation.
airborne. Not expected to be a health hazard via
inhalation.
Chronic Exposure:
The health risks associated with chronic
Ingestion:
radiation exposure (cancer, leukemia, genetic
May cause asymptomatic physiological uptake
and teratogenic effects) are believed to involve
by thyroid gland or other tissues.
levels of radiation exposure which are much
higher than those permitted occupationally.
Skin Contact:
Not expected to produce any acute adverse
Aggravation of Pre-existing Conditions:
health effects.
No information found.




GALLIUM CITRATE Ga 67 INJECTION
GALLIUM CITRATE Ga 67 INJECTION


SECTION 4. FIRST AID MEASURES
Inhalation: Skin Exposure:
Not expected to require first aid measures. If skin contact occurs, wash the affected area
thoroughly with soap and water until no more
Ingestion:
radioactivity can be removed. Always blot dry.
Notify radiation safety personnel immediately.
Do not abrade skin. Notify radiation safety
The amount of material ingested should be
personnel.
assessed and documented.
Eye Exposure:
If a splash occurs, wash eyes with water for at
least 15 minutes or until no more radioactivity
can be removed. Notify radiation safety
personnel.

SECTION 5. FIRE FIGHTING MEASURES
Fire: Not considered to be a fire hazard.
Explosion: Not considered to be an explosion hazard.
Fire Extinguishing Media: Use any means suitable for extinguishing surrounding fire.
Special Instructions: In the event of a fire, wear full protective clothing and NIOSH-approved
self-contained breathing apparatus with full facepiece operated in the pressure demand or other positive
pressure mode.


SECTION 6. ACCIDENTAL RELEASE MEASURES
If the product is received in a leaking condition or any loss or release of the radioactive contents occurs,
notify your Radiation Safety Department and Mallinckrodt at (314) 654-7860. All cleanup operations
should be performed according to the Standard Operating Procedures (SOPs) established for your facility
and by the NRC or other applicable local, state or federal regulations.

SECTION 7. HANDLING AND STORAGE
Store at 15掳C to 30掳C. Handling time should be kept to a minimum and appropriate shielding should be
used. Handling devices such as syringe shields and tongs should be used. Storage and disposal of
product should be controlled in a manner which is in compliance with the appropriate regulations of the
federal or state government agency authorized to license the use of this radionuclide.

SECTION 8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Airborne Exposure Limits: Respiratory Protection:
鈥揘RC Occupational concentration limit is Not expected to require personal respirator
6 x 10-6 碌Ci/mL of air. usage.
Engineering Controls: Skin Protection:
Properly sealed containers are not expected to Disposable plastic, latex, or rubber gloves;
require any special ventilation. labcoat.
Eye/Face Protection:
Safety glasses.
Precautions:
No smoking, eating, or drinking should be
allowed in any area where radioactive materials
are handled or stored.

2
GALLIUM CITRATE Ga 67 INJECTION


SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Clear, colorless liquid in a 10 mL Radioactivity: 3, 6 or 12 mCi/vial on the
glass vial. calibration date and time.
Odor: Odorless. Concentration: 2 mCi/mL on the calibration
date and time.
Solubility: Soluble in water.
Specific Activity: 2 mCi/8.3ng of gallium on the
Boiling Point: ca. 100掳C (212掳F).
calibration date and time.
Melting Point: ca. 0掳C (32掳F).
Half-Life: ca. 78.26 hours.



SECTION 10. STABILITY AND REACTIVITY
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: May emit radioactive fumes containing Ga 67 when heated to
decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: No information found.

SECTION 11. TOXICOLOGICAL INFORMATION
It is widely accepted by the scientific community that exposure to sufficient quantities of ionizing
radiation can potentially cause harmful biological effects which include cancer, leukemia, and genetic
and teratogenic effects. For detailed toxicological information on specific components, write to the
address listed in Section 1 - Attn: Regulatory Compliance Department.

SECTION 12. ECOLOGICAL INFORMATION
Because this product is intended for use by hospital or clinic patients, it is expected to be treated by
standard wastewater treatment facilities with no adverse environmental impacts.

SECTION 13. DISPOSAL CONSIDERATIONS
Gallium Citrate Ga 67 Injection is Radioactive Waste until the activity has decayed to nondetectable
levels. Radioactive waste must be handled in accordance with procedures established by your
Radiation Safety Officer, NRC and other applicable regulations.
If medical waste is involved, such as blood, blood products, or sharps, the waste must be handled as a
Biohazard and disposed of accordingly.
If not radioactive or a biohazard, waste Gallium Citrate Ga 67 Injection is considered non-hazardous.
Consult local, state and federal regulations for proper disposal.

SECTION 14. TRANSPORT INFORMATION
DOT (Department of Transportation):
Proper Shipping Name: Radioactive Material, n.o.s.
Hazard Class: 7
Identification Number: UN2982




3
GALLIUM CITRATE Ga 67 INJECTION

SECTION 15. REGULATORY INFORMATION
CERCLA Reportable Quantities:
Ga 67 = 100 Ci (3.7 E 12 Bq)
Releases to air, land or water of these hazardous substances which exceed the Reportable Quantity
(RQ) must be reported to the National Response Center at 800-424-8802.
SARA Title III
302 Extremely Hazardous Substances: None
311/312 Hazard Categories: Chronic
313 Toxic substances subject to annual release reporting requirements: None.
RCRA Hazardous Waste Status
Non-hazardous (See Section 13 for additional details.)
California Proposition 65 Warning
This product contains a substance known to the State of California to cause cancer.
Australian Hazchem Code: None allocated.
Australian Poison Schedule: None allocated.
WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products
Regulations (CPR) and the MSDS contains all of the information required by the CPR.



SECTION 16. OTHER INFORMATION
MSDS Status: Revised in accordance with ANSI Guideline Z400.1-1998
NFPA Ratings: Health: 1 Flammability: 0 Reactivity: 0
Product Use: Diagnostic imaging agent
Revision Information: Section 8 updated.




Mallinckrodt provides the information contained herein EXPRESS OR IMPLIED, INCLUDING WITHOUT
in good faith but makes no representation as to its LIMITATION ANY WARRANTIES OF MERCHANT-
comprehensiveness or accuracy. This document is ABILITY, FITNESS FOR A PARTICULAR PURPOSE
intended only as a guide to the appropriate WITH RESPECT TO THE INFORMATION SET
precautionary handling of the material by a properly FORTH HEREIN OR THE PRODUCT TO WHICH
trained person using this product. Individuals receiving THE INFORMATION REFERS. ACCORDINGLY,
the information must exercise their independent MALLINCKRODT WILL NOT BE RESPONSIBLE
judgment in determining its appropriateness for a FOR DAMAGES RESULTING FROM USE OF OR
particular purpose. MALLINCKRODT MAKES NO RELIANCE UPON THIS INFORMATION.
REPRESENTATIONS OR WARRANTIES, EITHER




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