Material Safety Data Sheet

Date Prepared: 10/17/03                                           X-GEN Pharmaceuticals

Prepared By: RC Park                                              PO Box 445

Technical Assistance: 607-562-2700                                Big Flats, NY 14814

ERYTHROMYCIN



                                        IDENTIFICATION



Common Name: Erythromycin

Chemical Name: Erythromycin

Synonym: Erythromycin A                                           Formula: C37H67NO13

CAS Number: 114-07-8                                              RTECS Number: KF4375000

Chemical Family: A Macrolide antibiotic

Therapeutic Category: Antibacterial

                                INGREDIENT INFORMATION



Principle Components                     Percent                            Exposure Limits

Erythromycin                             100 %                                    n/f



                            HEALTH HAZARD INFORMATION



Usual Adult Dose: The usual oral adult dose of erythromycin is 250 to 500 mg per day in divided

doses, not to exceed 4 grams daily. Erythromycin is also administered topically to the eye as a 0.5 to

1% ointment and to the skin as a 2 to 4% solution.



Adverse Effects: Adverse effects may include skin rash, redness, or itching; liver toxicity (fever,

nausea, skin rash, severe stomach pain, unusual tiredness or weakness, yellow eyes or skin,

vomiting); abdominal or stomach cramping or discomfort; diarrhea; nausea; vomiting; sore mouth or

tongue; white patches in mouth or on tongue; and genital itching or discharge. Possible allergic

reaction to material if inhaled, ingested or in contact with skin.



Overdose Effects: Symptoms of overdose include ringing in ears, severe gastrointestinal discomfort,

transient auditory impairment, and irregular heartbeat.

Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation.

Chronic: Possible hypersensitization, hepatoxicity, hearing loss, and superinfection.

Inhalation: May cause irritation. Remove to fresh air.

Eye: Causes mild irritation. Flush with copious quantities of water.

Skin: Causes irritation. Flush with copious quantities of soap and water.



n/f = not found

ERYTHROMYCIN



                       HEALTH HAZARD INFORMATION CONTINUED



Ingestion: May cause irritation and bitter taste. Flush out mouth with water. This material is variably

absorbed from the gastrointestinal tract.



Medical Conditions Aggravated by Exposure: Hypersensitivity to material, impaired liver

function, acute porphyria, and a history of cardiac arrhythmias or QT prolongation.



Cross Sensitivity: Persons sensitive to other erythromycins or macrolides may be sensitive to this

material also.



Pregnancy Comments: Adequate and well-controlled pregnancy studies have not been done in

humans. Erythromycin showed no evidence of birth defects or any other adverse effects on

reproduction in studies in female rats.



Pregnancy Category: B



                                     FIRST AID MEASURES



General: Remove from exposure. Remove contaminated clothing. Persons developing serious

hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If person is not

breathing give artificial respiration. If breathing is difficult give oxygen. Obtain medical attention.



Overdose Treatment: Overdose treatment may include the following:

1. Evacuate the stomach to eliminate unabsorbed material.

2. Administer epinephrine, corticosteroids, and antihistamines for allergic reactions.

3. Use supportive measures as needed.

4. Hemodialysis or peritoneal dialysis does not remove erythromycins. [USP DI 2001]



                             TOXICOLOGICAL INFORMATION



Oral Rat: LD50: 4600 mg/kg

Oral Mouse: LD50: 2580 mg/kg

Irritancy Data: n/f

Target Organ(s): Liver and gastrointestinal system

Listed as a Carcinogen? NTP: No                   IARC: No                  OSHA: No

                        Other: No



                                   FIREFIGHTING MEASURES



Flash Point: n/f                                            Upper Flammable Limit: n/f

Auto-Ignition Temperature: n/f                              Lower Flammable Limit: n/f

Extinguisher Media: Water spray, dry chemical, carbon dioxide or foam as appropriate for

surrounding fire and materials.





                                                                                                          2

n/f = not found

ERYTHROMYCIN



                          FIREFIGHTING MEASURES CONTINUED



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.



Firefighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should use

self-contained breathing equipment and protective clothing.



                                     PHYSICAL HAZARDS



Conditions to Avoid: Avoid exposure to heat and moisture.



Incompatibilities: Volatile organic solvents and acids.



Decomposition Products: When heated to decomposition material emits toxic fumes of NOx. Emits

toxic fumes under fire conditions.



Stable? Yes                      Hazardous Polymerization? No



                       HANDLING / SPILL / DISPOSAL MEASURES



Handling: As a general rule, when handling USP Reference Standards avoid all contact and

inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after handling.



Storage: Store in tight container as defined in the USP-NF. This material should be handled and

stored per label instructions to ensure product integrity. Store in a freezer.



Spill Response: Wear approved respiratory protection, chemically compatible gloves and protective

clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing

dust. Place spillage in appropriately labeled container for disposal. Wash spill site.



Disposal: Dispose of waste in accordance with all applicable Federal, State and local laws.



                  EXPOSURE CONTROLS / PERSONAL PROTECTION



 Respiratory Protection: When working with small quantities in a well-ventilated area, respiratory

protection may not be required. The use of an approved dust mask is recommended.



Ventilation: No special ventilation requirements.

Gloves: Rubber

Eye Protection: Safety Glasses

Protective Clothing: Protect exposed skin.









                                                                                                     3

n/f = not found

ERYTHROMYCIN





                        PHYSICAL AND CHEMICAL PROPERTIES



Appearance and Odor: White to pale yellow crystalline powder; odorless or practically odorless.

Melting Point: 135 - 140° C (resolidifies w/second m.p. @ 190 - 193° C)

Solubility in Water: Very slightly soluble                     Vapor Density: n/f

Solubility in Water: n/f                                       Evaporation Rate: n/f

Boiling Point: n/f                                             Evaporation Rate: n/f

Specific Gravity: n/f                                          Reactivity in Water: n/f

Vapor Pressure: n/f                                            % Volatile by Volume: n/f









                                                                                                  4

n/f = not found