MATERIAL SAFETY DATA SHEET



                              Hydromorphone Hydrochloride



PADDOCK LABORATORIES, INC.                    EMERGENCY ASSISTANCE:

3940 QUEBEC AVENUE NORTH                  CHEMTREC       800-424-9300

MINNEAPOLIS, MINNESOTA 55427                             202-483-7616

PHONE: (763)-546 -4676                    PADDOCK TECH. ASST. 800-328-5113

Date prepared: February 15, 1996 By: Matthew Greuel





         SECTION 1 - PRODUCT IDENTIFICATION AND HAZARDOUS COMPONENTS



PRODUCT NAME: Hydromorphone Hydrochloride



SYNONYMS: Dihydromorphinone Hydrochloride



MOLECULAR FORMULA: C17 H19NO3 HCl                                MOLECULAR WEIGHT: 322.5



CHEMICAL NAME: Morphinan-6-one,4,5-epoxy-3-hydroxy-17- methyl-,hydrochloride, (5 alpha)



CHEMICAL FAMILY: Morphinan derivative



INGREDIENT (CAS NUMBER)             %           OSHA PEL              ACGIH TLV

Hydromorphone Hydrochloride (71-68-1) 100      not established        not established





              SECTION 2 - PHYSICAL AND CHEMICAL CHARACTERISTICS

BOILING POINT:  N/A                   VAPOR PRESSURE: N/A



MELTING POINT: 305-315o C. w/Decomposition            VAPOR DENSITY:          N/A



SPECIFIC GRAVITY:          N/A                        EVAPORATION RATE: N/A

(WATER = 1)                                           (BUTYL ACETATE = 1)



WATER SOLUBILITY: Freely soluble                      WATER REACTIVE:           No



APPEARANCE AND ODOR: Fine, white or practically white, odorless, crystalline powder.





                     SECTION 3 - FIRE AND EXPLOSION DATA

FLASH POINT (METHOD): N/A           NFPA RATING: N/A



AUTOIGNITION TEMPERATURE: N/A

FLAMMABLE LIMITS: LOWER: N/A                    UPPER: N/A

EXTINGUISHING MEDIA: Water spray, carbon dioxide, dry chemical, or foam as appropriate for

surrounding fire conditions and materials. Class BC, ABC fire extinguishers



SPECIAL FIRE FIGHTING PROCEDURES: As with all fires, evacuate personnel to safe area. Firefighters

should use self- contained breathing equipment and protective clothing.



UNUSUAL FIRE AND EXPLOSION HAZARDS: This material is assumed to be combustible. As with all

dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the

potential buildup of static electricity. When heated to decomposition material emits toxic fumes of NOx and

HCl. Emits toxic fumes under fire conditions.





                               SECTION 4 - REACTIVITY HAZARD DATA

STABILITY: Stable ( X )        Unstable ( )



INCOMPATIBILITY (MATERIALS TO AVOID): Oxidizing agents, and heavy metal salts



HAZARDOUS DECOMPOSITION PRODUCTS: Produces toxic fumes ( NOx , and HCl ) when heated to

decomposition.



HAZARDOUS POLYMERIZATION: May Occur ( )                 Will Not Occur ( X )





                                 SECTION 5 - HEALTH HAZARD DATA

TOXICITY:             LD50 :        Subcutaneous (rat)   51mg/kg

                                    Subcutaneous (mouse) 120 mg/kg

                                    Intravenous (mouse)  55 mg/kg

                      LDLo:         Intravenous (cat)    3 mg/kg

                                    Intravenous (rabbit) 2500 micrograms/kg



Reproductive Effects Data [RTECS]

      The usual adult oral dose of hydromorphone hydrochloride is 2 mg every three to six hours as needed.

      Adverse effects include dizziness, sedation, nausea, vomiting, constipation, abdominal pain, skin rashes,

      lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, visual disturbances, liver

      dysfunction and palpitations. Central nervous system depression, respiratory depression, pinpoint pupils,

      coma, body temperature and blood pressure may fall. Possible allergic reaction to dust if inhaled,

      ingested or in contact with skin.



CARCINOGEN LISTED BY:                NTP      Yes ( ) No ( X )

                                     IARC     Yes ( ) No ( X )

                                     OSHA     Yes ( ) No ( X )

                                     Other    Yes ( ) No (X )

                                     ACGIH Other exposure

                                     TLV: n/a    Limits Used: n/a

SIGNS AND SYMPTOMS OF OVEREXPOSURE:



      INHALATION: Respiratory tract irritation possible. Remove to fresh air.



      EYE CONTACT: Possible Irritation, Flush with copious quantities of water, may cause narcotic effect

      exhibited by pupil contraction



      SKIN CONTACT: Possible Irritation, Flush with copious quantities of water.



      INGESTION: Narcotic. In addition to analgesic action, may cause gastric disturbance evidenced by

      nausea, vomiting, and constipation. Ingestion of large amounts may cause central nervous system

      depression, respiratory or cardiac collapse, coma and death.



CHRONIC EFFECTS OF OVEREXPOSURE: May cause addiction. Possible hypersensitization to this

material.



MEDICAL CONDITIONS AGGRAVATED BY OVEREXPOSURE: Sensitization may occur evidenced by

skin rashes, cough, stuffy nose, asthma and other allergic complaints.



OTHER PRECAUTIONS TO CONSIDER: Persons developing hypersensitivity (anaphylactic) reactions must

    receive immediate medical attention. Material may be irritating to mucous membranes and respiratory

    tract. Risk-benefit must be considered because opioid analgesics cross the placenta. Regular use during

    pregnancy may cause physical dependency in the fetus, leading to withdrawal symptoms (convulsions,

    irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing and

    yawning) in the neonate. Although teratogenic effects in humans have not been documented, controlled

    studies have not been done. Studies in animals have shown hydromorphone to be teratogenic in very

    high doses (FDA pregnancy Category C) [USP DI 9th ed. 1989]. As a general rule, when handling

    Hydromorphone Hydrochloride, avoid all contact and inhalation of dust, fumes, mists, and/or vapors

    associated with the material. Keep container tightly closed and use with adequate ventilation; wash

    thoroughly after handling. Individuals working with chemicals should consider all chemicals to be

    potentially hazardous even if their individual hazards may be uncharacterized or unknown.



EMERGENCY FIRST AID PROCEDURES:



      INHALATION: Seek immediate medical attention.



      EYE CONTACT: Flush with copious amounts of water. Obtain medical attention.



      SKIN CONTACT: Flush with copious amounts of water. Obtain medical attention.



      INGESTION: Seek immediate medical attention.



               SECTION 6 - CONTROL AND PROTECTIVE MEASURES

RESPIRATORY PROTECTION: NIOSH/MSHA approved respirator.

PROTECTIVE GLOVES: Rubber or Latex.



EYE PROTECTION: Safety goggles. Avoid wearing contact lenses when working with this or any chemical

due to the possibility of increased severity of eye damage.



VENTILATION: General or local exhaust recommended.



OTHER PROTECTIVE EQUIPMENT: Appropriate laboratory apparel. Protect exposed skin.



HYGIENIC WORK PRACTICES: Do not eat, drink or smoke near this material. Wash thoroughly after

handling and wash contaminated clothing before reuse.



                      SECTION 7 - HANDLING AND STORAGE PRECAUTIONS



STORAGE PRECAUTIONS: CONTROLLED SUBSTANCE (Schedule II). Storage location must comply

with all Drug Enforcement Administration regulations. Store in a tight container in a cool, dry, well ventilated

location.





                          SECTION 8 - SPILL AND DISPOSAL PROCEDURES



WASTE DISPOSAL METHOD: Dispose of in accordance with all applicable local, state, federal, and

environmental regulations.





                                        SECTION 9 - DISCLAIMER



__________________________________________________________________________________________

DEFINITIONS OF ABBREVIATIONS USED:



 ACGIH:        American Conference of Governmental Industrial Hygienists

 CAS:          Chemical Abstract Service

 IARC:         Internal Agency for Research on Cancer

 IDLH:         Immediately Dangerous to Life or Health level

 LC50 :        Median Lethal Concentration

 LD50 :        Median 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