MATERIAL SAFETY DATA SHEET
Midazolam HCl syrup 2 mg/mL
Paddock Laboratories, Inc. Emergency Assistance:
CHEMTREC庐 (24-hour)
3940 Quebec Avenue North 1-800-424-9300
Minneapolis, MN 55427
Tel: (763) 546-4676 Paddock Technical Assistance: 1-800-328-5113
Creation Date: 28 December 2004 Revision Date: 28 December 2004
SECTION 1: PRODUCT IDENTIFICATION
PRODUCT NAME: Midazolam HCl 2 mg/mL
COMMON NAME: Midazolam HCl 2 mg/mL
CHEMICAL NAME: 8-chloro-6(2-fluorophenyl)-1-methyl-4H-imidazo-[1,5a][1,4]-benzodiazepine
hydrochloride
SYNONYMS: NA
CHEMICAL FORMULA: C18H13CIFN3HCl
CHEMICAL FAMILY: Benzodiazepines
SECTION 2: COMPOSITION AND INGREDIENTS
CHEMICAL NAME CAS# OSHA PEL ACGIH TLV IDLH
*Midazolam 59467-70-8 NE NE NE
Sorbitol Solution 50-70-04 NE NE NE
Glycerin, USP 56-81-5 15 mg/m3 15 mg/m3 NE
*Citric Acid 77-92-9 NE NE NE
*Sodium Citrate 68-04-02 NE NE NE
*Sodium Benzoate 532-32-1 NE NE NE
*Disodium EDTA Dihydrate 6381-92-6 NE NE NE
*Hydrochloric Acid 7647-01-0 5 mg/m3 2 mg/m3 NE
*D & C Red no. 33 3567-66-6 10 mg/m3 10 mg/m3 NE
*Mixed Fruit Flavor N/A NE NE NE
*Bitter Mask N/A NE NE NE
Purified Water, USP grade NE NE NE
TO THE BEST OF OUR KNOWLEDGE THE INFORMATION CONTAINED HEREIN IS ACCURATE AS OF THE DATE HEREOF.
ANY DETERMINATION AS TO THE SUITABILITY OF THE PRODUCT FOR ANY PARTICULAR PURPOSE, ITS SAFE USE OR
DISPOSAL SHALL BE THE RESPONSIBILITY OF THE USER. THE INFORMATION CONTAINED HEREIN IS IN NO WAY
INTENDED TO SUPPLEMENT, MODIFY OR SUPERSEDE THE INFORMATION PROVIDED IN THE PRODUCT PACKAGE
INSERT WITH RESPECT TO THE USE OF THE PRODUCT FOR MEDICAL PURPOSES.
MSDS 鈥? Midazolam HCl Syrup 2 mg/mL Page 2 of 5
NE = Not Established, Specific amounts are considered proprietary information.
*These ingredients are at concentrations of less than 1%.
**Mixed Fruit Flavor and Bitter Mask are both mixtures and do not have a listed CAS#.
SECTION 3: HAZARDS INDENTIFICATION
EMERGENCY OVERVIEW: Midazolam HCl Syrup 2 mg/mL is a clear, red syrup with a fruity odor, free of particulate
matter.
Symptoms of Overexposure by Route of Exposure: The potential for overexposure is reduced in the finished
pharmaceutical form. Possible overexposure effects are sedation, somnolence, confusion, impaired coordination,
diminished reflexes, coma.
SECTION 4: FIRST AID MEASURES
Skin Exposure: Thoroughly wash with mild soap and water if irritation develops.
Eye Exposure: Immediately flush eye with copious amounts of water and seek medical attention.
Inhalation: Inhalation exposure is not expected to occur. If symptoms occur, move to fresh air and seek
medical attention.
Ingestion: Seek medical attention. Never induce vomiting to an unconscious or convulsing person.
SECTION 5: FIRE / EXPLOSION HAZARDS & FIRE-FIGHTING MEASURES
Flash Point: NE Autoignition Temperature: NE
Flammable Limits (in air by volume, %): Lower: NE Upper: NE
Fire Extinguishing Equipment: Use extinguishing agent suitable for type of surrounding fire.
Water Spray: OK Carbon Dioxide: OK Halon: OK
Foam: OK Dry Chemical: OK Other: Any 鈥淎BC鈥? Class
Unusual Fire and Explosion Hazards: No unusual fire or explosion hazards are expected.
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
Special Fire Fighting Procedures: For fires beyond the incipient stage, emergency responders in the immediate
hazard area should wear full protective clothing and a self contained breathing apparatus. When the potential
chemical hazard is unknown, in enclosed or confined spaces, or when explicitly required by the DOT Emergency
Response Guidebook, a self-contained breathing apparatus should be worn. In addition, wear other appropriate
protective equipment as conditions warrant (see Section 8). Isolate immediate hazard area and keep unauthorized
personnel out. Contain spill if it can be done with minimal risk. Move undamaged containers from immediate hazard
area if it can be done with minimal risk. Cool equipment exposed to fire with water, if it can be done with minimal
risk.
SECTION 6: SPILL AND LEAK PROCEDURES
Spill and Leak Response:
Clean up material and place in an appropriate disposal container. Avoid runoff into storm sewers and ditches which
lead to waterways. Consult local authorities regarding notification requirements.
MSDS 鈥? Midazolam HCl Syrup 2 mg/mL Page 3 of 5
SECTION 7: HANDLING AND STORAGE
Work and Hygiene Practices: As with all chemicals, avoid getting this product ON YOU or IN YOU. Do not eat,
drink, smoke or apply cosmetics while handling the product. Wash hands thoroughly after handling.
Storage and Handling Practices: Store at controlled room temperature 15掳C to 30掳C (59掳F to 86掳F). Store away
from oxidizing agents, avoid exposure to direct light, and avoid strong bases. Wash hands before eating. Avoid
contact with eyes, skin, and clothing.
Protective Practices During Maintenance of Contaminated Equipment: ND
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
Ventilation and Engineering Controls: No special ventilation required under normal condition of use.
Respiratory Protection: No special requirements under normal conditions.
Eye Protection: Although the risk from eye exposure is minimal, prudence recommends the use of safety glasses.
Hand Protection: No special requirements under normal condition of use. Gloves should be worn during spill clean
up.
Body Protection: No special requirements under normal conditions of use.
Product Preparation Instructions for Medical Personnel: Follow standard procedure for handling pharmaceutical
materials and recommendations presented on the Package Insert.
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES
Boiling Point: ND Vapor Pressure: ND
Melting/Freezing Point: ND pH: 3
Water Solubility: Soluble Water Reactive: No
Specific Gravity (Water =1): ND Evaporation Rate (Butyl acetate = 1): ND
Appearance/Odor: Clear red liquid with a fruity odor.
ND = No Data
SECTION 10: STABILITY AND REACTIVITY
Stability: Stable under labeled storage conditions.
Incompatible Materials: Oxidizing agents, bases.
Hazardous Polymerization: High temperatures may liberate toxic gas.
Conditions to Avoid: Protect from light.
SECTION 11: TOXICOLOGICAL INFORMATION
Toxicity Data: Oral LD50 Rat = 1600 mg/kg
Suspected Cancer Agent: This product has NOT been identified as a carcinogen by NTP, IARC or OSHA.
MSDS 鈥? Midazolam HCl Syrup 2 mg/mL Page 4 of 5
Irritancy of Product: During normal use of product no eye contact should occur.
Sensitization to the Product: Not Known.
Reproductive Information: Although VERSED Syrup has not been studied in pregnant patients an increased risk of
congenital malformations associated with the use of benzodiazepine drugs (diazepam and chlordiazepoxide) have
been suggested in several studies. If this drug is used during pregnancy the patient should be apprised of the
potential hazard to the fetus.
Mutagenicity: ND
Embryotoxicity/Teratogenicity/Reproductive Toxicity: ND
ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs) associated with the
components of this product.
SECTION 12: ECOLOGICAL INFORMATION
All work practices must be aimed at eliminating environmental contamination.
Environmental Stability: This product will be relatively stable under ambient environmental conditions.
Effect of Materials on Plants/Animals/Aquatic Life: No information is currently available on the environmental impact
of this product.
SECTION 13: WASTE DISPOSAL
Preparing Wastes for Disposal: This is a DEA class IV product. Dispose of material according to local disposal
regulations or company operating procedures or DEA procedures
U.S. EPA Waste Number: None
SECTION 14: TRANSPORTATION INFORMATION
This Material is not Hazardous as Defined by 49 CFR 172.101 by the U. S. Department of Transportation
Proper Shipping Name: Not applicable
Hazard Class Number and Description: Not applicable
UN Identification Number: Not applicable
Packing Group: Not applicable
DOT Label(s) Required: Not applicable
North American Emergency Response Guidebook Number (1996): Not applicable.
MARINE POLLUTANT: No component of this product is listed as a Marine Pollutant (49 CFR 172.101, Appendix B)
Transport Canada Transportation of Dangerous Goods Regulations: Not applicable
SECTION 15: REGULATORY INFORMATION
U.S. REGULATIONS:
MSDS 鈥? Midazolam HCl Syrup 2 mg/mL Page 5 of 5
U.S. SARA Reporting Requirements: 311/312 Hazard Categories: Immediate Health, 313 Reportable Ingredients:
None
U.S. SARA Threshold Planning Quantity: Not applicable
U.S. CERCLA Reportable Quantities (RQ): Not applicable
U.S. TSCA Inventory Status: Midazolam HCl syrup is a 鈥渄rug鈥? as defined by the Federal Food, Drug and Cosmetic
Act and is therefore not a chemical substance under TSCA.
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): This product does NOT contain a
chemical known to the State of California to cause developmental and reproductive effects.
WARNING! Midazolam HCl 2 mg/mL syrup should be administered under the supervision of a qualified physician.
SECTION 16: OTHER INFORMATION
DEFINITIONS OF ABBREVATIONS USED:
ACGIH: American Conference of Governmental Industry Hygienists
CAS: Chemical Abstract Service
IARC: International Agency for Research on Cancer
IDLH: Immediately Dangerous to Life or Health Level
LC50: Medial Lethal Concentration
LD50: Medial Lethal Dose
MSHA: Mine Safety and Health Administration
N/A: Not Available
NIOSH: National Institute for Occupational Safety and Health
NTP: National Toxicology Program
OSHA: Occupational Safety and Health Administration
PEL: Permissible Exposure Limit
STEL: Short Term Exposure Limit
TLV: Threshold Limit Value
TWA: Time Weighted Average
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