Tramadol HCl BP/EP

MSDS Number: TRMLD * * * * * Effective Date: 01/15/01 * * * * * Supercedes: 06/01/99 TRAMADOL Analytical Research Standards

TRAMADOL Analytical Research Standards

1. Product Identification

Synonyms: Tramadol HCl ARS; Tramadol impurities;
CAS No.: Not applicable.
Molecular Weight: Not applicable.
Chemical Formula: Not applicable.
Product Codes: 1119, 2229, 3339, 4449, 5559

2. Composition/Information on Ingredients

  Ingredient                                CAS No         Percent   Hazardous                                       
  ---------------------------------------   ------------   -------   ---------        
  Tramadol hydrochloride impurities         N/A              100%       Yes                                                               

3. Hazards Identification

Emergency Overview

Potential Health Effects

Although there is no available information on the specific human health effects from exposure to Tramadol's degradation products and process impurities, the health effects are expected to be similar to Tramadol Hydrochloride. The health effects from exposure to Tramadol Hydrochloride are given below.

Narcotic. Can irritate the respiratory passages and cause sneezing or coughing but will also have an anesthetic effect. Inhalation of appreciable quantities may produce dizziness, somnolence, nausea, constipation, sweating, puritus. and respiratory difficulties. May act as a respiratory sensitizer. If sensitization to this product occurs, subsequent respiratory contact may result in rhinitis, conjunctivitis, or asthma.
Toxic. Narcotic. Human lethal dose estimated at 3 to 5 grams. In addition to its analgesic action, Tramadol HCl can cause, cyanosis, weak pulse, dizziness, somnolence, nausea, constipation, sweating, puritus, respiratory depression and seizure. Death from respiratory failure can occur.
Skin Contact:
Not expected to cause health effects, although the possibility of absorption exists under conditions of skin breakage or inflammation. May act as a skin sensitizer. If sensitization occurs, subsequent skin contact may result in contact dermatitis.
Eye Contact:
Mild irritant but will also have a strong narcotic effect (pupil contraction), if systemic absorption occurs.
Chronic Exposure:
When taken at therapeutic doses for extended periods, Tramadol can lead to habituation and addiction. This drug has been associated with craving, drug-seeking behavior and tolerance development.
Aggravation of Pre-existing Conditions:
Tramadol HCl should not be given to opioid-dependent patients. Can reinitiate physical dependence in patients that have been previously dependent or chronically using other opiods. Seizure risks are increased for individuals under the influence of alcohol or other CNS depressants.

4. First Aid Measures

Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact:
Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Call a physician, immediately. Wash clothing before reuse.
Eye Contact:
Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.

5. Fire Fighting Measures

As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Not considered to be an explosion hazard.
Fire Extinguishing Media:
Water spray, dry chemical, alcohol foam, or carbon dioxide.
Special Information:
In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full facepiece operated in the pressure demand or other positive pressure mode.

6. Accidental Release Measures

Ventilate area of leak or spill. Wear appropriate personal protective equipment as specified in Section 8. Spills: Sweep up and containerize for reclamation or disposal. Vacuuming or wet sweeping may be used to avoid dust dispersal.

7. Handling and Storage

Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage. Containers of this material may be hazardous when empty since they retain product residues (dust, solids); observe all warnings and precautions listed for the product.

8. Exposure Controls/Personal Protection

Airborne Exposure Limits:
None established.
Ventilation System:
A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
Personal Respirators (NIOSH Approved):
For conditions of use where exposure to the dust or mist is apparent, a half-face dust/mist respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
Skin Protection:
Wear protective gloves and clean body-covering clothing.
Eye Protection:
Use chemical safety goggles. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures:
Allergic responses in sensitive individuals will disappear if removed from exposure.

9. Physical and Chemical Properties

White crystals.
Soluble in water.
Not applicable.
No information found.
% Volatiles by volume @ 21C (70F):
No information found.
Boiling Point:
No information found.
Melting Point:
No information found.
Vapor Density (Air=1):
No information found.
Vapor Pressure (mm Hg):
No information found.
Evaporation Rate (BuAc=1):
No information found.

10. Stability and Reactivity

Discolors on exposure to light.
Hazardous Decomposition Products:
Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization:
Will not occur.
Alkalis, tannin, strong oxidizing agents, borax, ferric chloride, iodides, lead acetate, mercuric chloride, gold salts.
Conditions to Avoid:
No information found.

11. Toxicological Information

Tramadol HCl: Oral rat LD50: 228 mg/kg
  --------\Cancer Lists\------------------------------------------------------
                                         ---NTP Carcinogen---
  Ingredient                             Known    Anticipated    IARC Category
  ------------------------------------   -----    -----------    -------------
  Tramadol hydrochloride impurities       No          No            None

12. Ecological Information

Environmental Fate:
No information found.
Environmental Toxicity:
No information found.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing, use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements.

14. Transport Information

Not regulated.

15. Regulatory Information

  --------\Chemical Inventory Status - Part 1\---------------------------------
  Ingredient                                       TSCA  EC   Japan  Australia
  -----------------------------------------------  ----  ---  -----  ---------
  Tramadol hydrochloride impurities               Exempt No    No       No                                        
  --------\Chemical Inventory Status - Part 2\---------------------------------
  Ingredient                                       Korea  DSL   NDSL  Phil.
  -----------------------------------------------  -----  ---   ----  -----
  Tramadol hydrochloride impurities                 No    No    No     No                              
  --------\Federal, State & International Regulations - Part 1\----------------
                                             -SARA 302-    ------SARA 313------
  Ingredient                                 RQ    TPQ     List  Chemical Catg.
  -----------------------------------------  ---   -----   ----  --------------
  Tramadol hydrochloride impurities          No    No      No         No
  --------\Federal, State & International Regulations - Part 2\----------------
                                                        -RCRA-    -TSCA-
  Ingredient                                 CERCLA     261.33     8(d) 
  -----------------------------------------  ------     ------    ------
  Tramadol hydrochloride impurities          No         No         No                   
Chemical Weapons Convention:  No     TSCA 12(b):  No     CDTA:  No
SARA 311/312:  Acute: Yes      Chronic: Yes  Fire: No  Pressure: No
Reactivity: No          (Pure / Solid) 

Australian Hazchem Code: None Allocated.
Poison Schedule: None Allocated.
This MSDS has been prepared according to the hazard criteria of the Controlled Products Regulations (CPR) and the MSDS contains all of the information required by the CPR.

16. Other Information

NFPA Ratings: Health: 3 Flammability: 1 Reactivity: 0
Label Hazard Warning:
Label Precautions:
Avoid breathing dust.
Avoid contact with eyes, skin and clothing.
Keep container closed.
Wash thoroughly after handling.
Use with adequate ventilation.
Label First Aid:
In all cases call a physician immediately. If swallowed, induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person. If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. In case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes.
Product Use:
Analytical Research Standard. For FDA Regulated Use Only.
Revision Information:
MSDS Section(s) changed since last revision of document include: 3.
Mallinckrodt provides the information contained herein in good faith but makes no representation as to its comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose. MALLINCKRODT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, MALLINCKRODT WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION.
Prepared by: Strategic Services Division
Phone Number: (314) 654-1600 (U.S.A.)