SAFETY DATA SHEET

1. Identification
Product identifier

Prednisone

Other means of identification
Catalog number

1559006

CAS number53-03-2

Synonyms

1-Dehydrocortisone

Chemical name

Pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-

Recommended use

Specified quality tests and assay use only.

Recommended restrictions

Not for use as a drug. Not for administration to humans or animals.

Manufacturer/Importer/Supplier/Distributor information
Manufacturer
Company name
Address

Telephone
WebsiteE-mailEmergency phone number

U. S. Pharmacopeia
12601 Twinbrook Parkway
Rockville
MD20852-1790
United StatesRS Technical Services
www.usp.org
RSTECH@usp.org
CHEMTREC within US &CanadaCHEMTREC outside US &Canada301-816-8129

1-800-424-9300+1 703-527-3887

2. Hazard(s) identification
Physical hazards

Not classified.

Health hazards

Reproductive toxicity

Category 2

Specific target organ toxicity, repeatedexposure

Category 1 (endocrine system)

Environmental hazards

Not classified.

OSHA defined hazards

Not classified.

Label elements

Signal word

DangerHazard statement

Suspected of damaging fertility or the unborn child. Causes damage to organs (endocrine system)
through prolonged or repeated exposure.

Precautionary statement
Prevention

Obtain special instructions before use. Do not handle until all safety precautions have been readand understood. Do not breathe dust. Wash thoroughly after handling. Wear protective
gloves/protective clothing/eye protection/face protection.

Response

If exposed or concerned: Get medical advice/attention. Get medical advice/attention if you feelunwell.

Storage

Store locked up.

Disposal

Dispose of contents/container in accordance with local/regional/national/international regulations.

Hazard(s) not otherwiseclassified (HNOC)

None known.

Supplemental information

Potent pharmacologically active material.

3. Composition/information on ingredients
Substance
Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

USP SDS USIssue date: 08-20-2010

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Chemical namePrednisone

Common name and synonyms
1-Dehydrocortisone

CAS number%

53-03-2100

4. First-aid measures

Skin contact

Move to fresh air. If breathing is difficult, remove to fresh air and keep at rest in a position
comfortable for breathing. Call a physician if symptoms develop or persist.
Rinse skin with water/shower. Get medical attention if irritation develops and persists.

Eye contact

Rinse with water. Get medical attention if irritation develops and persists.

Ingestion

Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately.

Most important
symptoms/effects, acute anddelayed

Endocrine system effects. Potent pharmacologically active material. Occupational exposure tosmall amounts may cause physiological effects.

Indication of immediate
medical attention and special
treatment needed

Treat symptomatically. Treatment of corticosteroid overdose should be symptomatic andsupportive and may include the following: Toxicity is low after acute ingestion. Gastrointestinal
decontamination is generally not necessary. (Poisindex)

General information

Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance froman occupational health physician or other licensed health-care provider familiar with workplacechemical exposures. In the United States, the national poison control center phone number is
1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, giveoxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions mustreceive immediate medical attention.

Inhalation

5. Fire-fighting measures
Suitable extinguishing media
Unsuitable extinguishing
media

Water. Foam. Dry chemical or CO2. Use fire-extinguishing media appropriate for surrounding
materials.
None known.

Specific hazards arising fromthe chemical

No unusual fire or explosion hazards noted.

Special protective equipment
and precautions for firefighters

Wear suitable protective equipment.

Fire fighting
equipment/instructions

Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area.
Firefighters should use self-contained breathing equipment and protective clothing.

Specific methods

Use standard firefighting procedures and consider the hazards of other involved materials.

General fire hazards

No unusual fire or explosion hazards noted.

6. Accidental release measures
Personal precautions,protective equipment andemergency procedures
Methods and materials forcontainment and cleaning up
Environmental precautions

Keep unnecessary personnel away. Wear appropriate personal protective equipment. Avoid
inhalation of dust from the spilled material. Do not touch damaged containers or spilled material
unless wearing appropriate protective clothing. Ensure adequate ventilation. For personalprotection, see section 8 of the SDS.
For waste disposal, see section 13 of the SDS. Avoid the generation of dusts during clean-up.
Sweep up or vacuum up spillage and collect in suitable container for disposal. Clean surface
thoroughly to remove residual contamination.
Prevent further leakage or spillage if safe to do so. Avoid discharge into drains, water courses oronto the ground.

7. Handling and storage
Precautions for safe handling

Conditions for safe storage,including any incompatibilities

As a general rule, when handling USP Reference Standards, avoid all contact and inhalation ofdust, mists, and/or vapors associated with the material. Clean equipment and work surfaces withsuitable detergent or solvent after use. After removing gloves, wash hands and other exposed skinthoroughly. Select and use containment devices and personal protective equipment based on arisk assessment of material potency and exposure potential.
Store in tight container as defined in the USP-NF. This material should be handled and stored perlabel instructions to ensure product integrity.

8. Exposure controls/personal protection
Occupational exposure limits
The following constituents are the only constituents of the product which have a PEL, TLV or other recommended exposure limit.
At this time, the other constituents have no known exposure limits.
Exposure limit values
Industrial Use
Material
Prednisone (CAS 53-03-2)
Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

TypeValue

TWA

50 micrograms/m3
USP SDS USIssue date: 08-20-2010

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Biological limit values

No biological exposure limits noted for the ingredient(s).

Appropriate engineering
controls

No open handling. For laboratory operations, use approved ventilation or containment system(biological safety cabinet, ventilated balance enclosure, glovebox). Control exposures to below theoccupational exposure level (if available). Select and use containment devices and personal
protective equipment based on a risk assessment of exposure potential. Cover all containers forsolutions and slurries while being transferred.

Individual protection measures, such as personal protective equipment
Wear safety glasses with side shields, chemical splash goggles, or full face shield, if necessary.
Eye/face protection
Base the choice of protection on the job activity and potential for contact with eyes or face. An
emergency eye wash station should be available.
Skin protection
Hand protection

Other

Respiratory protection

Thermal hazards
General hygiene
considerations

Consider double gloves. Wear nitrile or other impervious gloves if skin contact is possible. Whenthe material is dissolved or suspended in an organic solvent, wear gloves that provide protection
against the solvent.
Train employees in proper gowning and degowning practices. Wear disposable lab coat,disposable sleeve covers and two pair of gloves as appropriate for the task. Base the choice ofskin protection on the job activity, potential for skin contact and solvents and reagents in use. Do
not wear protective garments in common areas (e.g., cafeterias) or out-of-doors.
Use a powered air-purifying respirator (PAPR) with HEPA filters, disposable outerware and head
cover for spill cleanup. Chose respiratory protection appropriate to the task and the level ofexisting engineering controls.
Wear appropriate thermal protective clothing, when necessary.
Pharmacological effects may be seen with occupational exposure. Handling practices in this SDS
are recommendations for laboratory use of reference standards. Procedures for any other uses orquantities should be determined after an appropriate assessment.

9. Physical and chemical properties
Appearance

Appearance descriptions are general information and not specific to any USP lot.

Physical stateSolid.

Form

Powder.

ColorWhite.

Odor

Odorless.

Odor threshold

Not available.

pH

Not available.

Melting point/freezing point

446 - 455 °F (230 - 235 °C) (decomposes)Initial boiling point and boilingrange

Not available.

Flash point

Not available.

Evaporation rate

Not available.

Flammability (solid, gas)

Not available.

Upper/lower flammability or explosive limits
Not available.
Flammability limit - lower(%)
Flammability limit - upper(%)

Not available.

Explosive limit - lower (%)

Not available.

Explosive limit - upper (%)

Not available.

Vapor pressure

Not available.

Vapor density

Not available.

Relative density

Not available.

Solubility(ies)
Solubility (water)

Very slightly soluble.

Solubility (other)

Methanol: Slightly soluble.
Ethanol: Slightly soluble.
Chloroform: Slightly soluble.

Partition coefficient(n-octanol/water)

1.46

Auto-ignition temperature

Not available.

Decomposition temperature

Not available.

Viscosity

Not available.

Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

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Issue date: 08-20-2010

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Other information
Chemical family

Corticosteroid.

Molecular formula

C21H26O5

Molecular weight358.44

10. Stability and reactivity
Reactivity

The product is stable and non-reactive under normal conditions of use, storage and transport.

Chemical stability

Material is stable under normal conditions.

Possibility of hazardous
reactions

No dangerous reaction known under conditions of normal use.

Conditions to avoid

Contact with incompatible materials.

Incompatible materials

Strong oxidizing agents.

Hazardous decomposition
products

Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions.

11. Toxicological information
Information on likely routes of exposure
Knowledge about health hazard is incomplete.
Inhalation
Skin contact

Knowledge about health hazard is incomplete.

Eye contact

Knowledge about health hazard is incomplete.

Ingestion

Based on information from therapeutic use, this material may cause: Endocrine effects.

Symptoms related to thephysical, chemical, andtoxicologicalcharacteristics

Corticosteroids: Fluid and electrolyte imbalance. Adrenal suppression. Immunosuppression.
Cushing's syndrome. High blood pressure. Gastrointestinal disturbances. Headache.
Lightheadedness. Weakness. Visual disturbances. Mood or mental status changes. Infection.
Thinning skin. Swelling. Bruising. Bone fractures. Back pain. Joint pain. Tremors. Menstrualirregularities. Impotence.

Information on toxicological effects
Acute toxicity

Not known.

Skin corrosion/irritation

Knowledge about health hazard is incomplete.

Serious eye damage/eyeirritation

Knowledge about health hazard is incomplete.

Respiratory or skin sensitization
Knowledge about health hazard is incomplete.
Respiratory sensitization
Skin sensitization

Knowledge about health hazard is incomplete.

Germ cell mutagenicity

Knowledge about mutagenicity is incomplete.

Mutagenicity
Ames test (Salmonella typhimurium)
Result: Negative
Mouse lymphoma assay
Result: Negative
Mutagenicity, In vivo chromosome aberration studies in rat
bone marrowResult: Negative
Knowledge about carcinogenicity is incomplete.
Carcinogenicity
5 mg/kg/day Carcinogenicity
Result: Negative
Species: Mouse
IARC Monographs. Overall Evaluation of Carcinogenicity
Prednisone (CAS 53-03-2)
3 Not classifiable as to carcinogenicity to humans.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not regulated.
US. National Toxicology Program (NTP) Report on Carcinogens
Not listed.
Suspected of damaging fertility or the unborn child. Most studies have concluded that therapeutic
Reproductive toxicity
use of corticosteroids by pregnant women does not cause adverse effects on the fetus. A small
increase in the incidence of cleft palate was seen in some human studies. Infants born to mothers
who received substantial doses of corticosteroids during pregnancy should be observed for signsof hypoadrenalism.

Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

USP SDS US

Issue date: 08-20-2010

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Reproductivity
10 mg/day Epidemiological study, Statistically significant
decrease in birth weights of term infants.
Result: PositiveSpecies: HumanSpecific target organ toxicity single exposureKnowledge about health hazard is incomplete.

Specific target organ toxicity repeated exposure

Causes damage to organs (endocrine system) through prolonged or repeated exposure.

Aspiration hazard

Based on available data, the classification criteria are not met.

Further information

Potent pharmacologically active material. Occupational exposure to small amounts may cause
physiological effects.

12. Ecological information
Ecotoxicity
ProductSpecies

Test Results

Algae

31 mg/l, 72 hours

Prednisone (CAS 53-03-2)
AquaticAcuteAlgae

IC50

Persistence and degradability

No data is available on the degradability of this product.

Bioaccumulative potential
Octanol/water partition coefficient log Kow
1.46
No data available.
Mobility in soil
Other adverse effects

No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.

13. Disposal considerations
Disposal instructions

Local disposal regulations
Hazardous waste code
Waste from residues / unusedproductsContaminated packaging

Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of theuser of the product to determine, at the time of disposal, whether the product meets RCRA criteria
for hazardous waste.
Dispose in accordance with all applicable regulations.
The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Empty containers or liners may retain some product residues. This material and its container must
be disposed of in a safe manner (see: Disposal instructions).
Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container isemptied.

14. Transport information
DOT
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
Not applicable.
Transport in bulk according toAnnex II of MARPOL 73/78 andthe IBC Code
General information

It is the shipper's responsibility to determine the correct transport classification at the time ofshipment.

15. Regulatory information
US federal regulations

This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication
Standard, 29 CFR 1910.1200.

TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.

Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

USP SDS US

Issue date: 08-20-2010

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OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not regulated.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
Immediate Hazard - No
Hazard categories
Delayed Hazard - Yes
Fire Hazard - No
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely hazardous substanceNot listed.
SARA 311/312 Hazardous
chemicalYes

SARA 313 (TRI reporting)
Not regulated.
Other federal regulations
Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Not regulated.
Safe Drinking Water Act(SDWA)
US state regulations

WARNING: This product contains a chemical known to the State of California to cause birthdefects or other reproductive harm.

International Inventories
Country(s) or region
Australia

Inventory name
Australian Inventory of Chemical Substances (AICS)

On inventory (yes/no)*Yes

CanadaDomestic Substances List (DSL)

No

CanadaNon-Domestic Substances List (NDSL)

Yes

China

Inventory of Existing Chemical Substances in China (IECSC)

No

EuropeEuropean Inventory of Existing Commercial Chemical
Substances (EINECS)

Yes

EuropeEuropean List of Notified Chemical Substances (ELINCS)

No

Japan

Inventory of Existing and New Chemical Substances (ENCS)

Yes

Korea

Existing Chemicals List (ECL)Yes

New Zealand

New Zealand Inventory

Yes

Philippines

Philippine Inventory of Chemicals and Chemical Substances(PICCS)

Yes

United States & Puerto Rico

Toxic Substances Control Act (TSCA) Inventory

Yes*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governingcountry(s).

16. Other information, including date of preparation or last revision
Issue date

08-20-2010

Revision date

01-11-2018

Version #04
USP Reference Standards are sold for chemical test and assay purposes only, and NOT for
human consumption. The information contained herein is applicable solely to the chemical
substance when used as a USP Reference Standard and does not necessarily relate to any otheruse of the substance described, (i.e. at different concentrations, in drug dosage forms, or in bulkquantities). USP Reference Standards are intended for use by persons having technical skill andat their own discretion and risk. This information has been developed by USP staff from sources
considered reliable but has not been independently verified by the USP. Therefore, the USPConvention cannot guarantee the accuracy of the information in these sources nor should thestatements contained herein be considered an official expression. NO REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE is made with respect to the information containedherein.

Disclaimer

Material name: Prednisone
1559006 Version #: 04 Revision date: 01-11-2018

USP SDS USIssue date: 08-20-2010

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