Material Safety Data Sheet
NFPA HMIS PPE Transport Symbol
Chronic Hazard Star Legend
Issuing Date 21-May-2009 Revision Date Revision Number 0
1. PRODUCT AND COMPANY IDENTIFICATION
Product Name NICARdipine Hydrochloride Injection
Product Code(s) 10139-700-10 - 10 mL Vial
10139-700-11 - Shelf Pack (10 mL Vials X 10)
Recommended Use Calcium channel blocker
Supplier Address GeneraMedix Inc.
150 Allen Road
Liberty Corner, New Jersey 07938, USA
TEL: 908-504-1300
Chemical Emergency Phone Number Chemtrec 1-800-424-9300
2. HAZARDS IDENTIFICATION
Emergency Overview
Irritating to eyes.
Appearance Clear, Yellow Physical State Liquid Odor No data available.
Potential Health Effects
Principle Routes of Exposure Inhalation. Skin contact. Eye contact.
Acute Toxicity
Eyes Irritating to eyes.
Skin May cause skin irritation and/or dermatitis.
Inhalation Not an expected route of exposure. Inhalation of aerosols:. May cause irritation of respiratory
tract.
Ingestion May be harmful if swallowed. May cause gastrointestinal discomfort if consumed in large
amounts.
Chronic Effects None known.
Aggravated Medical Conditions None known.
Environmental Hazard See Section 12 for additional Ecological Information.
3. COMPOSITION/INFORMATION ON INGREDIENTS
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Chemical Name CAS-No Weight %
Water for Injection 7732-18-5 ~95
Sorbitol 50-70-4 4.8
Nicardipine HCL 54527-84-3 0.25
Citric acid 77-92-9 0.0525
Sodium hydroxide 1310-73-2 0.009
Additional citric acid and/or sodium hydroxide may be added to adjust to target pH = 3.5.
4. FIRST AID MEASURES
General Advice Immediate medical attention is not required. Show this safety data sheet to the doctor in
attendance.
Eye Contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. If
symptoms persist, call a physician.
Skin Contact Wash off immediately with soap and plenty of water.
Inhalation Not an expected route of exposure. Move to fresh air.
Ingestion Clean mouth with water and afterwards drink plenty of water. Do NOT induce vomiting. Never
give anything by mouth to an unconscious person. Consult a physician.
Notes to Physician Treat symptomatically
5. FIRE-FIGHTING MEASURES
Flammable Properties Not flammable
Flash Point N/A
Suitable Extinguishing Media Use extinguishing measures that are appropriate to local circumstances and the surrounding
environment.
Explosion Data
Sensitivity to Mechanical Impact None
Sensitivity to Static Discharge None
Protective Equipment and Precautions for Firefighters
As in any fire, wear self-contained breathing apparatus and full protective gear.
NFPA Health Hazard 1 Flammability 0 Stability 0 Physical and Chemical
Hazards N/A
HMIS Health Hazard 1 Flammability 0 Stability 0 Personal Protection N/A
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Avoid contact with eyes.
Methods for Containment Prevent further leakage or spillage if safe to do so.
Methods for Cleaning Up Soak up with inert absorbent material. After cleaning, flush away traces with water. Clean
contaminated surface thoroughly.
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7. HANDLING AND STORAGE
Handling Handle in accordance with good industrial hygiene and safety practice. Wear personal
protective equipment. Avoid contact with skin and eyes.
Storage Store at room temperature. Keep at temperatures between 20 癈 and 25 癈. Protect from light.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Guidelines
Chemical Name ACGIH TLV OSHA PEL NIOSH IDLH
3 3 3
Sodium hydroxide Ceiling: 2 mg/m TWA: 2 mg/m IDLH: 10 mg/m
3 3
(vacated) Ceiling: 2 mg/m Ceiling: 2 mg/m
NIOSH IDLH: Immediately Dangerous to Life or Health
Engineering Measures Showers, eyewash stations, and ventilation systems
Personal Protective Equipment
Eye/Face Protection Safety glasses with side-shields.
Skin and Body Protection Lightweight protective clothing.
Respiratory Protection No protective equipment is needed under normal use conditions. If exposure limits are
exceeded or irritation is experienced, ventilation and evacuation may be required.
Hygiene Measures Handle in accordance with good industrial hygiene and safety practice.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance Odor
Clear, Yellow No data available.
Odor Threshold Physical State
No data available. Liquid
pH 3.5
Flash Point Autoignition Temperature
N/A N/A
Decomposition Temperature Boiling Point/Range
No data available. >100癈
Melting Point/Range No data available.
Flammability Limits in Air Explosion Limits
No data available. No data available.
Molecular Weight Water Solubility
No data available. Soluble in water
Evaporation Rate Vapor Pressure
No data available. No data available.
Vapor Density VOC Content
No data available. N/A
Partition Coefficient No data available.
(n-octanol/water)
10. STABILITY AND REACTIVITY
Stability Stable under recommended storage conditions.
Incompatible Products Strong oxidizing agents, Strong acids, Strong bases.
Conditions to Avoid Excessive heat.
Hazardous Decomposition Products None under normal use.
Hazardous Reactions Hazardous polymerization does not occur.
Hazardous Polymerization Hazardous polymerization does not occur.
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11. TOXICOLOGICAL INFORMATION
Acute Toxicity
Product Information No acute toxicity information is available for this product.
Not an expected route of exposure.
Inhalation
Irritating to eyes. Expected to be an irritant based on components
Eye Contact
Prolonged contact may cause redness and irritation.
Skin Contact
Low order of toxicity based on components. Ingestion may cause irritation to mucous
Ingestion
membranes
Other LD50 intraperitoneal = 155 mg/kg (rat) (54527-84-3 Nicardipine HCL)
LD50 intravenous = 155 mg/kg (rat) (54527-84-3 Nicardipine HCL)
LD50 intraperitoneal = 123 mg/kg (mouse) (54527-84-3 Nicardipine HCL)
Component Information
Chemical Name LD50 Oral LD50 Dermal LC50 Inhalation
Citric acid 3000 mg/kg ( Rat )
Sodium hydroxide 1350 mg/kg ( Rabbit )
Sorbitol 15900 mg/kg ( Rat )
Nicardipine HCL 184 mg/kg ( Rat )
Chronic Toxicity
Chronic Toxicity None known.
Carcinogenicity There are no known carcinogenic chemicals in this product. Rats treated with nicardipine in the
diet for two years showed a dose-dependent increase in thryoid cancer. (folicular
adenoma/carcinoma). Other studies in rats have suggested that these results are due to a
nicardipine-induced reduction in plasma thyroxine (T4) level which can elevated thyroid
stimulating hormone (TSH) levels. Chronic elevation of TSH is known to cause
hyperstimulation of the thyroid.
Reproductive Toxicity Pregnant rabbits and rats dosed with Nicardipine I.V. at doses of 1 mg/kg/day and 10
mg/kg/day respectively showed evidence of embryotoxicity, but no teratogenicity. Other
feeding studies of pregnant rabbits and rats at various times during the gestation period
showed no evidence of embryolethality or teratogenicity. However, dystocia, reduced birth
weights, reduced neonatal survival time, and reduced neonatal weight gains were noted.
There are no adequate and well-controlled studies in pregnant women. Excreted in breast milk.
Target Organ Effects Central Vascular System (CVS), Thyroid, Reproductive system, Liver.
12. ECOLOGICAL INFORMATION
Ecotoxicity
Ecotoxicity Effects The environmental impact of this product has not been fully investigated.
Chemical Name Toxicity to Algae Toxicity to Fish Toxicity to Microorganisms Daphnia Magna (Water Flea)
Citric acid N/A LC50= 1516 mg/L Lepomis EC50 = 14 mg/L 15 min EC50 = 120 mg/L 72 h
macrochirus 96 h
Sodium hydroxide N/A LC50= 45.4 mg/L N/A N/A
Oncorhynchus mykiss 96 h
Chemical Name Log Pow
Citric acid 20
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13. DISPOSAL CONSIDERATIONS
Waste Disposal Methods This material, as supplied, is not a hazardous waste according to Federal regulations (40 CFR
261). This material could become a hazardous waste if it is mixed with or otherwise comes in
contact with a hazardous waste, if chemical additions are made to this material, or if the
material is processed or otherwise altered. Consult 40 CFR 261 to determine whether the
altered material is a hazardous waste. Consult the appropriate state, regional, or local
regulations for additional requirements.
Contaminated Packaging Dispose of in accordance with local regulations.
14. TRANSPORT INFORMATION
DOT Not regulated.
TDG Not regulated.
MEX Not regulated.
ICAO Not regulated.
IATA Not regulated.
IMDG/IMO Not regulated.
RID Not regulated.
ADR Not regulated.
ADN Not regulated.
15. REGULATORY INFORMATION
International Inventories
TSCA Exempt
DSL Does not Comply
EINECS/ELINCS Complies
ENCS Does not Comply
IECSC Does not Comply
KECL Complies
PICCS Does not Comply
AICS Complies
U.S. Federal Regulations
SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any
chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372.
SARA 311/312 Hazard Categories
Acute Health Hazard Yes
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Chronic Health Hazard No
Fire Hazard No
Sudden Release of Pressure Hazard No
Reactive Hazard No
Clean Water Act
This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40 CFR
122.42).
CERCLA
This material, as supplied, contains one or more substances regulated as a hazardous substance under the Comprehensive
Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302):.
Chemical Name Hazardous Substances RQs Extremely Hazardous Substances RQs
Sodium hydroxide 1000 lb
U.S. State Regulations
California Proposition 65
This product does not contain any Proposition 65 chemicals.
U.S. State Right-to-Know Regulations
Chemical Name Massachusetts New Jersey Pennsylvania Illinois Rhode Island
Sodium hydroxide X X X N/A X
International Regulations
Chemical Name Carcinogen Status Exposure Limits
3
Sodium hydroxide Mexico: Ceiling= 2 mg/m
Canada
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR) and the
MSDS contains all the information required by the CPR.
WHMIS Hazard Class
Non-controlled. Not regulated under CEPA.
16. OTHER INFORMATION
Issuing Date 21-May-2009
Revision Date No data available.
Revision Note No data available.
Disclaimer
The information provided on this MSDS is correct to the best of our knowledge, information and belief at the date of its publication. The
information given is designed only as a guide for safe handling, use, processing, storage, transportation, disposal and release and is not to
be considered as a warranty or quality specification. The information relates only to the specific material designated and may not be valid
for such material used in combination with any other material or in any process, unless specified in the text.
End of Safety Data Sheet
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