Phosphotec Kit For The Preparation Of Technetium Tc 99m Pyrophosphate (Vials Containing Lyophilized Powder)

Phosphotec Kit For The Preparation Of Technetium Tc 99m Pyrophosphate (Vials Containing Lyophilized Powder)
Bracco Diagnostics, Inc.

Phosphotec Kit For The Preparation Of Technetium Tc 99m Pyrophosphate (Vials Containing Lyophilized Powder)

MSDS Name: Phosphotec Kit For The Preparation Of Technetium Tc 99m Pyrophosphate (Vials Containing Lyophilized Powder)
Manufacturer Name: Bracco Diagnostics, Inc.
Address:
P.O. Box 5225
Princeton, NJ 08543

EMERGENCY CONTACTS:
(Health): 1-800-257-5181.
(U.S. Transportation): Chemtrec 1-800-424-9300.
(International Transportation): Chemtrec 1-703-527-3887.
Manufacturer MSDS Revision Date: January 31, 2001
Supersedes: November 7, 2000
Supersedes: March 6, 1992
Supersedes: January 14, 1992
Synonyms:
For Active Ingredient: Tetrasodium pyrophosphate (for sodium pyrophosphate).
Chemical Family: Not available.
General Use:
Bone, cardiac and blood pool diagnostic imaging agent. When supplied as a lyophilized powder and sodium pertechnetate Tc 99m solution is added to the vial, a diagnostic agent, technetium Tc 99m pyrophosphate is formed for intravenous administration. NOTE: The Tc 99m solution is not provided by Bracco Diagnostics Inc.
HDR####

The author of this Material Safety Data Sheet (MSDS) is Bracco Diagnostics Inc. This MSDS is generated and/or distributed by the Bristol-Myers Squibb Company on behalf of Bracco Diagnostics Inc. Please carefully review all of the information disclosed in this MSDS prior to handling or using the product referenced below.

Chemical Name (for active ingredients): Sodium pyrophosphate, stannous fluoride.

How Supplied: As a Kit (Ten 5 mL reaction vials containing lyophilized powder).

CAS NUMBERS:
(Sodium pyrophosphate) 7722-88-5
(Stannous fluoride) 7783-47-3 .

EMERGENCY OVERVIEW: Aqueous solution. Non-combustible. See Health Effects and Toxicology sections for additional information.

Molecular Formula: For actives- Na4P2O7, SnF2.

PHOSPHOTEC MATERIAL SAFETY DATA SHEET
SECTION 2 : COMPOSITION, INFORMATION ON INGREDIENTS
Chemical Name
Water for injection, USP
CAS#
7732-18-5
% Weight
CONCENTRATION: ~96%
% Volume
CONCENTRATION: ~96%
Other Exposure Guidelines:
Chemical Name
Sodium pyrophosphate
CAS#
7722-88-5
% Weight
CONCENTRATION: ~4
% Volume
CONCENTRATION: ~4
Components present at < 1% or used for pH adjustment: Stannous fluoride, sodium hydroxide, hydrochloric acid.
SECTION 3 : HAZARDS IDENTIFICATION
Emergency Overview:
Aqueous solution. Non-combustible. See Health Effects and Toxicology sections for additional information.
Applies to All Ingredients:
Route of Exposure:
Inhalation, Skin Contact, Ingestion
Potential Health Effects:
Eye Contact:
Acute: No information. Solution contains low concentrations of irritant compounds. It may have the potential to produce mild eye irritation.
Skin Contact:
Exposure may occur via skin contact if gloves and protective clothing are not worn. The extent of systemic absorption of the material after skin contact is not known.

Acute:
Toxic: Contact with small quantities of material for short periods is not expected to result in pharmacologic or toxic effects.

Irritation: Material contains low concentrations of components that are mild irritants or possible irritants. It may have potential to cause mild irritation, however, moderate or severe irritation is not expected.

Sensitization: This material may act as a sensitizer (allergen) for those persons who are allergic to the formulation or components in the formulation.
Inhalation:
Under normal conditions, exposure to this material by inhalation is not expected to occur. However, in a situation where the liquid would be aerosolized, there may be potential for inhalation. The extent of systemic absorption of the material after inhalation is not known.

Acute: Inhaling small doses of aerosolized material would not be expected to result in symptoms.
Ingestion:
Ingestion of large quantities of this material in an occupational setting would not be expected to occur. Ingestion of trace amounts of the material might occur if the material contacts hands and hands are not washed prior to eating, drinking or smoking. The extent of systemic absorption of the material after ingestion is not known.

Acute: Inadvertent ingestion of trace amounts of this material would not be expected to result in symptoms.
Chronic Health Effects:
Repeated and prolonged exposure to skin may cause skin irritation.
Carcinogenicity:
OSHA Designation:
No
NTP Designation:
No
IARC Designation:
No
Target Organs:
None known.
Aggravation of Pre-Existing Conditions:
None known.

Exposure Guideline Summary: An exposure guideline has not been established for this material.
SECTION 4 : FIRST AID MEASURES
Eye Contact:
Hold eyelids apart and flush with plenty of water for 5 minutes. Get medical attention if signs of irritation develop.
Skin Contact:
Remove contaminated clothing. Wash skin with plenty of water for 5 minutes. Seek medical attention if irritation (redness, itching or swelling) develops or persists.
Inhalation:
Remove exposed person to fresh air. If person is not breathing, give artificial respiration. If breathing is difficult administer oxygen. Get medical attention immediately.
Ingestion:
Get medical attention immediately. Vomiting may be induced if a person is conscious and if ingestion has occurred within the past three hours. Never induce vomiting in a person who is unconscious or experiencing convulsions.
Note to Physicians:
None.
SECTION 5 : FIRE FIGHTING MEASURES
Fire:
Combustibility of Dusts: Not applicable, material exists as a liquid.
Flash Point:
Not applicable.
Upper Flammable or Explosive Limit:
Not applicable.
Lower Flammable or Explosive Limit:
Not applicable.
Auto Ignition Temperature:
Not applicable.
Extinguishing Media:
In case of fire, flood with water.
Hazardous Combustion Byproducts:
Phosphorous oxides, trace hydrofluoric acid, trace hydrochloric acid, trace tin oxides.
Fire Fighting Instructions:
Firefighters should wear self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves. Evacuate personnel to an upwind direction, remove unneeded material and cool container(s) with water from a maximum distance.
Sensitivity to Impact:
Explosion data relative to mechanical impact: No information.
Static Discharge Effects:
Explosion data relative to static discharge: No information.
Unusual Fire Hazards:
None.
SECTION 6 : ACCIDENTAL RELEASE MEASURES
Spill Cleanup Measures:
Lab coat, impermeable gloves (latex or nitrile) and eye protection should be worn as a minimum precaution. Absorb spill with inert material, e.g. sand, vermiculite or other non-combustible absorbent materials, and place into a closed container for reclamation or disposal. The spill area should be ventilated and decontaminated after material has been picked up.
SECTION 7 : HANDLING and STORAGE
Handling:
Avoid splashing of liquid product. Avoid skin and eye contact.
Storage:
Store at room temperature not exceeding 30 deg C). Protect from light.
Hygiene Practices:
Wash hands after handling product and before eating, smoking, using lavatory and at the end of the day.

Container Requirements: Store in the container provided. Use only glass or glass-lined containers; do not store in metal containers.
SECTION 8 : EXPOSURE CONTROLS, PERSONAL PROTECTION
Ventilation System:
None beyond good room ventilation.
Hand Protection Description:
Protective Gloves: Wear impervious gloves (latex, latex/nitrile, or nitrile) if the potential exists for dermal contact.
Eye/Face Protection:
Wear safety glasses (ANSI Z87.1).
Protective Clothing/Body Protection:
Special Clothing: None.
Respiratory Protection:
Not necessary for normal production environment. Non-routine exposure conditions may require NIOSH approved respiratory protection appropriate for exposure potential. Self-contained breathing apparatus should be available for emergency use.
Exposure Limits:
Exposure Guideline Summary: An exposure guideline has not been established for this material.

Hygiene: Wash hands after handling product and before eating, smoking, using lavatory and at the end of the day.
SECTION 9 : PHYSICAL AND CHEMICAL PROPERTIES
Physical State/Appearance:
Powder.
pH:
5.5-6.9. (reconstituted solution)
Vapor Pressure:
Minimal, material exists as a solid.
Vapor Density:
Not available.
Boiling Point:
Not applicable.
Freezing Point:
< 0 deg C.
Melting Point:
Not available
Solubility:
In Water: Soluble.
Specific Gravity:
Not applicable for lyophile; the reconstituted solution is similar to water.
Evaporation Point:
Not applicable.
Viscosity:
(cp): Not applicable.
Odor Threshold:
Not available.
Coefficient of Water/Oil Distribution:
Octanol/Water Partition Coefficient: Not available.
Flashpoint:
Not applicable.
Auto Ignition Temp:
Not applicable.
Upper Flammable Explosive Limit:
Not applicable.
Lower Flammable Explosive Limit:
Not applicable.

Flash Point: Not available.
SECTION 10 : STABILITY AND REACTIVITY
Chemical Stability:
Stable under normal conditions.
Incompatibilities with Other Materials:
Reactive with metals as a chelating or complexing agent. Store only in glass or glass-lined containers.
Reactivity:
Conditions of Reactivity: No information.
Hazardous Polymerization:
None.
Hazardous Decomposition Products:
May produce noxious products including phosphorous oxides, trace hydrofluoric acid, trace hydrochloric acid, trace tin oxides.

Explosion data relative to mechanical impact: No information.

Explosion data relative to static discharge: No information.
SECTION 11 : TOXICOLOGICAL INFORMATION
Sodium pyrophosphate:
Acute Health Effects:
No information
Inhalation Effects:
LC50: Not applicable, exists as a liquid at room temperature.
Carcinogenicity:
No information.
Mutagenicity:
No information.
Teratogenicity:
No information.
Reproductive Toxicity:
No information.
Other Toxicological Information:
RTECS # (U.S.): None provided.

Toxicological Synergistic Products: No information.
Comments:
TOXICOLOGICAL INFORMATION – For active ingredients
SECTION 12 : ECOLOGICAL INFORMATION
Ecotoxicity:
Not available.

Chemical Fate Information: Not available.
SECTION 13 : DISPOSAL CONSIDERATIONS
Waste Disposal:
Dispose in accordance with national, state, local or applicable country regulations.
SECTION 14 : TRANSPORT INFORMATION
DOT Shipping Information:
Placard Requirements: Not applicable.
DOT Shipping Name:
Not classified.
DOT UN Number:
Not classified.
DOT Hazard Class: Not classified.
DOT Packing Group: Not classified.
DOT Subpart E Labeling Requirement: Not applicable.

International:
Proper Shipping Name: Not classified.
Hazard Class, UN Number, Packing Group: Not classified.
Label Requirements: Not applicable.
Placard Requirements: Not applicable.
SECTION 15 : REGULATORY INFORMATION
Applies to all ingredients:
US Federal:
None noted.
European Community Chemical Inventory Status:
EC Labeling: Not applicable.
International Chemical Inventory Lists:
None noted.

NOTE: Not meant to be all-inclusive.
SECTION 16 : ADDITIONAL INFORMATION
Label Text:
Diagnostic agents are intended for use under direction of a physician and under the conditions of use described on the label and in the product’s package insert. As a general precaution, personnel who handle these products should avoid contact (ingestion, inhalation, skin and eye contact) with them.

This material safety data sheet is intended for use by personnel who handle this material as part of their job responsibilities and it does not address the diagnostic use of this material. Information concerning the use of this diagnostic agent should be obtained from the product package insert and other appropriate references.
MSDS Revision Date:
January 31, 2001
Supersedes: November 7, 2000
Supersedes: March 6, 1992
Supersedes: January 14, 1992

January 31, 2001: MSDS updated by Bracco Diagnostics, Inc.
March 6, 1992: MSDS updated.
January 14, 1992: MSDS updated.
MSDS Author:
Bracco Diagnostics Inc.
Disclaimer:
The information contained in this MSDS was obtained by Bracco Diagnostics from sources believed to be accurate and reliable and represents information currently on file and known by Bracco. However, Bracco makes no representation, guaranty or warranty, express or implied, with respect to any such information, and specifically disclaims and assumes no liability resulting from the use, misuse or mishandling of either the product or this MSDS.

Copyright© 1996-2005 Actio Software Corporation. All Rights Reserved.