Page 1 of 4 ?Hydromorphone Hydrochloride Tablets USP
IN CASE OF EMERGENCY
Emergency Phone: (614) 276-4000
Material Safety Data Sheet
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Common/Trade Name: Hydromorphone Hydrochloride Tablets USP
Chemical Name: 4,5-alpha-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride
Synonyms: None
Molecular Formula: C17H19NO3 ?HCl
Molecular Weight: 321.81
CAS No: 71-68-1
Chemical Family: Opioid analgesic
Product Use: Management of pain
Boehringer Ingelheim Roxane Inc.
Manufacturer's Name:
1809 Wilson Road
Address:
Columbus, Ohio 43228
2. COMPOSITION / INFORMATION ON INGREDIENTS
Composition CAS# Exposure Limit
Hydromorphone Hydrochloride (active ingredient) 71-68-1 None established
REFER to PHYSICIAN'S DESK REFERENCE for common components present as <1%
3. HAZARDS IDENTIFICATION
Emergency Physical State: Round tablets
Overview The 2 mg tablets are white, scored with "54 743" on one side.
The 4 mg tablets are white, scored with "54 609" on one side.
Odor: No data available
WARNING!
Hydromorphone Hydrochloride is an opioid analgesic.
May be harmful if swallowed.
Accidental ingestion of large amounts may be fatal.
Primary Route(s)
of Entry 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 in final pharmaceutical form.
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. Can cause respiratory depression, apnea, dizziness, and
nausea.
Toxicity Data: See Section 11
Effects of The potential for exposure is reduced in finished pharmaceutical form.
Overexposure: Overexposure may cause respiratory depression, extreme somnolence, skeletal muscle
flaccidity and pupil dilation. Severe overexposure can cause apnea, circulatory collapse,
cardiac arrest and death.
Target Organs: Central nervous system
4. FIRST AID MEASURES
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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.
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 N/A Upper: N/A
Lower:
Flash Point Not available
Extinguishing Media Use water spray, dry chemical, carbon dioxide or material appropriate for fire in
surrounding area
Special Fire Fighting
Procedures Wear full protective clothing and self-contained breathing apparatus.
Unusual Fire/Explosion
Hazards Not Applicable
Hazardous Combustion
Products Carbon dioxide, carbon monoxide, oxides of nitrogen, hydrogen chloride
6. ACCIDENTAL RELEASE INFORMATION
STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF PRODUCT IS SPILLED:
Use appropriate personal protective equipment (see Section 8). Sweep 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 Observe good industrial hygiene practices.
Handling Significant
Quantities:
Storage Store at 15?and 30癈 (59?to 86癋). Keep container closed tightly. Protect from light and
moisture. Store away from foodstuffs.
8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Exposure Limits None
Engineering Controls Not required when handling tablets or containers. Ventilation should be matched to
conditions.
Respiratory Not required when handling tablets 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 White, round tablets Melting point Not available Solubility in Soluble
water
Odor Not available Boiling point Not available Specific Gravity Not available
Taste Not available Vapor Pressure Not available Flashpoint Not available
pH Not available Density Not available Flammability Not available
Limits
10. STABILITY AND REACTIVITY DATA
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Stability Stable
Incompatibility Oxidizing agents, heavy metal salts
Hazardous
Decomposition Oxides of carbon, oxides of nitrogen, hydrogen chloride
Conditions to
Avoid Excessive heat, light
Hazardous
Polymerization Will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity:
Active Ingredient:
No data available
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: Drug Enforcement Administration controlled substances must be destroyed
following DEA Guidelines for witnessed destruction of the product beyond reclamation. 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: Hydromorphone Hydrochloride is a DEA Schedule II controlled substance.
FDA: Hydromorphone Hydrochloride 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. Hydromorphone Hydrochloride Tablets USP , Package Insert, Boehringer Ingelheim Roxane, Inc.,
Columbus, Ohio
2. RTECS No. QD2625000 - Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5'-alpha)-
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
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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.
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