SAFETY DATA SHEET

1. Identification
Product identifier

Dissolution Performance Verification Standard - Prednisone

Other means of identification
Catalog number

1222818

Recommended use

For analytical laboratory 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 States
Customer Service
www.usp.org
RSTECH@usp.org
CHEMTREC within US &CanadaCHEMTREC outside US &Canada301-881-0666

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

2. Hazard(s) identification
Physical hazards

Not classified.

Health hazards

Serious eye damage/eye irritation

Category 2B

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

Causes eye irritation. Suspected of damaging fertility or the unborn child. Causes damage toorgans (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/fume/gas/mist/vapors/spray. Wash thoroughly after
handling. Wear protective gloves/protective clothing/eye protection/face protection.

Response

If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present andeasy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. If exposed orconcerned: Get medical advice/attention.

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.

Material name: Dissolution Performance Verification Standard - Prednisone1222818 Version #: 01 Issue date: 11-02-2022

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1 / 103. Composition/information on ingredients
MixtureChemical nameCommon name and synonyms

CAS number%

7757-93-9>40

Microcrystalline Cellulose

9004-34-6>40

Colloidal silicone dioxide

112945-52-5<10Dicalcium Phosphate Anhydrous

557-04-0<10Prednisone

Magnesium Stearate
1-Dehydrocortisone

53-03-2<10

Sodium Dodecyl Sulfate Fine

Sulfuric acid monododecyl ester sodiumsalt

151-21-3<109063-38-1<10Sodium Starch Glycolate Type A

Information provided in the SDS is not specific to the lot provided. Refer to the label and USP Certificate/Product Information Sheet for
the assigned value of a particular lot.

4. First-aid measures
Inhalation

Move to fresh air. Call a physician if symptoms develop or persist.

Skin contact

Wash off with soap and water. Get medical attention if irritation develops and persists.

Eye contact

Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
Rinse mouth. Get medical attention if symptoms occur. If ingestion of a large amount does occur,
call a poison control center immediately.
Potent pharmacologically active material. Occupational exposure to small amounts may cause
physiological effects. Endocrine system effects.

Ingestion
Most important
symptoms/effects, acute anddelayedIndication of immediate
medical attention and special
treatment needed

Provide general supportive measures and treat symptomatically.

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.

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 personal
protection, see section 8 of the SDS.
Avoid the generation of dusts during clean-up. Sweep up or vacuum up spillage and collect insuitable container for disposal. Clean surface thoroughly to remove residual contamination. For
waste disposal, see section 13 of the SDS.
Avoid discharge into drains, water courses or onto the ground.

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2 / 107. Handling and storage
Precautions for safe handling

Conditions for safe storage,
including any incompatibilities

As a general rule, when handling USP materials, avoid all contact and inhalation of dust, mists,
and/or vapors associated with the material. Clean equipment and work surfaces with suitable
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. This material should be handled and stored per label 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.
US. OSHA Table Z-1 Limits for Air Contaminants (29 CFR 1910.1000)
Components
Type
Microcrystalline Cellulose(CAS 9004-34-6)

PEL

US. OSHA Table Z-3 (29 CFR 1910.1000)
Components
Colloidal silicone dioxide(CAS 112945-52-5)

Value

Form

5 mg/m3

Respirable fraction.

15 mg/m3

Total dust.

Type

Value

TWA

0.8 mg/m3
20 mppcf

US. ACGIH Threshold Limit Values
Components
Magnesium Stearate (CAS557-04-0)
Microcrystalline Cellulose(CAS 9004-34-6)

Type

Value

Form

TWA

3 mg/m3

Respirable fraction.

10 mg/m3

Inhalable fraction.

TWA

US. NIOSH: Pocket Guide to Chemical Hazards
Components
Type
Colloidal silicone dioxide(CAS 112945-52-5)
Microcrystalline Cellulose(CAS 9004-34-6)
Exposure limit values
Industrial Use
Components
Prednisone (CAS 53-03-2)

10 mg/m3

Value

Form

TWA

6 mg/m3

TWA

5 mg/m3

Respirable.

10 mg/m3

Total

Type

Value

TWA

50 micrograms/m3

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

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.

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3 / 10OtherRespiratory protection

Thermal hazards
General hygiene
considerations

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. Choose 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 USP materials.

9. Physical and chemical properties
Appearance

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

Physical state

Solid.

Form

Tablet.

Color

White. Off-white.

Odor

Not available.

Odor threshold

Not available.

pH

Not available.

Melting point/freezing point

Not available.

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)

Not available.

Auto-ignition temperature

Not available.

Decomposition temperature

Not available.

Viscosity

Not available.

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. Fluorine.

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
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4 / 10Skin contact

Knowledge about health hazard is incomplete.

Eye contact

Causes eye irritation.

Ingestion

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

Symptoms related to thephysical, chemical andtoxicological characteristics

Mineralocorticoid effects: Swelling. Confusion. Lightheadedness. Nausea. Vomiting. Numbness.
Tremors.
Glucocorticoid effects: Bone fractures. Back pain. Joint pain or stiffness. Weakness. Increased
appetite. Infection. Delayed wound healing. Thinning skin. Bruising. Purple lines on skin.
Increased hair growth. Acne. Redistribution of body fat. Menstrual irregularities. Impotence.
Headache. Increased sweating. Eye pain. Change in vision. Mental or behavioral changes.
Withdrawal effects: Fever. Muscle pain. Joint pain. Malaise.

Information on toxicological effects
Acute toxicity
Components

Species

Test Results

Colloidal silicone dioxide (CAS 112945-52-5)
Acute
DermalLD50

Rabbit> 2000 mg/kg, 24 Hours

Oral
LD50

Rat

> 3300 mg/kg

Dicalcium Phosphate Anhydrous (CAS 7757-93-9)
Acute
DermalLD50

Rabbit> 7940 mg/kg> 2000 mg/kg, 24 Hours

Inhalation
Dust
LC50

Rat

> 2.6 mg/l, 4 Hours

Oral
LD50

Rat

> 10000 mg/kg> 2000 mg/kg

Microcrystalline Cellulose (CAS 9004-34-6)
Acute
DermalLD50

Rabbit> 2 g/kg

Inhalation
LC50

Rat

> 5.05 mg/l, 4 hours

Oral
LD50

Rat

> 5 g/kg

Sodium Dodecyl Sulfate Fine (CAS 151-21-3)
Inhalation
LC50

Rat

> 3900 mg/m3, 3 hours

DermalLD50

Rabbit> 2000 mg/kg

Oral
LD50

Rat

1200 mg/kg

Acute

Sodium Starch Glycolate Type A (CAS 9063-38-1)
Acute
Oral
LD50
Skin corrosion/irritation

Rat> 2000 mg/kg

Knowledge about health hazard is incomplete.

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5 / 10Serious eye damage/eye
irritation

Causes eye irritation.

Local effects
Colloidal silicone dioxide

Sodium Dodecyl Sulfate Fine

Magnesium Stearate
Microcrystalline Cellulose
Dicalcium Phosphate Anhydrous

Colloidal silicone dioxide

Sodium Dodecyl Sulfate Fine

Magnesium Stearate
Microcrystalline Cellulose

Draize Test
Result: Negative.
Species: Rabbit
Organ: Eye
Eye irritation (Draize)
Result: Irritant.
Species: Rabbit
Eye irritation (Draize)
Result: Irritant.
Species: Rabbit
Severity: Moderate.
Eye irritation (Draize)
Result: Irritant.
Species: Rabbit
Severity: Severe.
Eye irritation
Result: Negative.
Species: Rabbit
Eye irritation
Result: Negative.
Species: Rabbit
Irritancy test
Result: Mild
Species: Rabbit
Organ: Eye
Irritancy test
Result: Non-irritantSpecies: Rabbit
Organ: Skin
Irritation test
Result: Slight
Species: Rabbit
Organ: Skin
Skin irritation (Draize)
Result: Irritant.
Species: Human
Skin irritation (Draize)
Result: Irritant.
Species: Rabbit
Skin irritation
Result: Negative.
Species: Rabbit
Skin irritation
Result: Negative.
Species: Rabbit

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

Knowledge about sensitization hazard is incomplete.

Colloidal silicone dioxide

Guinea pig maximization test
Result: Negative.
Sodium Dodecyl Sulfate Fine
Maximisation Test
Result: Not sensitizing
Species: Guinea pig
Organ: Skin.
Microcrystalline Cellulose
Skin sensitization
Result: Negative.
Species: Guinea pig
Knowledge about mutagenicity is incomplete.
Germ cell mutagenicity
Mutagenicity
Prednisone
Sodium Dodecyl Sulfate Fine

Ames test (Salmonella typhimurium)
Result: Negative
Ames test (Salmonella typhimurium)
Result: Negative.

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6 / 10Mutagenicity
Colloidal silicone dioxide
Microcrystalline Cellulose
Colloidal silicone dioxide
Microcrystalline Cellulose
Prednisone
Microcrystalline Cellulose
Sodium Dodecyl Sulfate Fine
Prednisone
Sodium Dodecyl Sulfate Fine
Colloidal silicone dioxide
Microcrystalline Cellulose
Carcinogenicity
Microcrystalline Cellulose

Prednisone
Sodium Dodecyl Sulfate Fine

Colloidal silicone dioxide

Magnesium Stearate
Microcrystalline Cellulose

Ames test
Result: Negative.
Ames test
Result: Negative.
Chromosome aberration test (CHO)
Result: Negative.
Micronucleus test
Result: Negative.
Mouse lymphoma assay
Result: Negative
Mouse lymphoma assay
Result: Negative.
Mutagenicity, In vitro clastogenic assay (Chinese hamster
fibroblasts)
Result: Negative.
Mutagenicity, In vivo chromosome aberration studies in rat
bone marrow
Result: Negative
Mutagenicity, Sister chromatid exchange (Chinese hamster
ovary cells)
Result: Weakly positive.
Unscheduled DNA synthesis assay
Result: Negative.
Unscheduled DNA synthesis
Result: Negative.

Knowledge about carcinogenicity is incomplete.
30 % Oral feed study
Result: Negative.
Species: Rat
Test Duration: 72 weeks
5 mg/kg/day Carcinogenicity
Result: Negative
Species: Mouse
Carcinogenicity
Result: Negative.
Species: Dog
Test Duration: 1 years
Carcinogenicity, Dietary study (5%)
Result: Negative.
Species: Mouse
Carcinogenicity, Dietary study (5%)
Result: Negative.
Species: Rat
Carcinogenicity: Implanted mouse bladders
Result: Negative.
Carcinogenicity; subcutaneous implant
Result: Negative.
Species: Rat
Test Duration: 2 years

IARC Monographs. Overall Evaluation of Carcinogenicity
Colloidal silicone dioxide (CAS 112945-52-5)
3 Not classifiable as to carcinogenicity to humans.
Prednisone (CAS 53-03-2)
3 Not classifiable as to carcinogenicity to humans.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
US. National Toxicology Program (NTP) Report on Carcinogens
Not listed.
Suspected of damaging fertility or the unborn child.
Reproductive toxicity
Most studies have concluded that therapeutic use of corticosteroids by pregnant women does notcause adverse effects on the fetus. A small increase in the incidence of cleft palate was seen insome human studies. Infants born to mothers who received substantial doses of corticosteroids
during pregnancy should be observed for signs of hypoadrenalism.

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7 / 10Reproductivity
Prednisone

10 mg/day Epidemiological study, Statistically significant
decrease in birth weights of term infants.
Result: Positive
Species: Human
170 - 1700 mg/kg/day Reproductivity, Increased rates of fetal
malformation and death at maternally toxic doses (topical).
Species: Mouse
200 mg/kg/day Reproductivity, Increased rates of fetal
malformations and death at maternally toxic doses (oral).
Species: Mouse
4.6 mg/kg/day Reproductivity / developmental
Result: No adverse effects on the offspring observed.
Species: Rat
500 mg/kg Reproductivity
Result: No evidence of adverse effects.
Species: Rat

Sodium Dodecyl Sulfate Fine

Microcrystalline Cellulose
Colloidal silicone dioxide

Specific target organ toxicity single exposure

Knowledge 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
Components

Species

Test Results

Dicalcium Phosphate Anhydrous (CAS 7757-93-9)
Aquatic
Acute
Crustacea

EC50

Daphnia magna> 1000 mg/l

IC50

Algae

31 mg/l, 72 hours

Prednisone (CAS 53-03-2)
Aquatic
Acute
Algae

Sodium Dodecyl Sulfate Fine (CAS 151-21-3)
Aquatic
Crustacea

EC50

Water flea (Daphnia obtusa)

9.2 - 10.4 mg/l, 48 hours

Fish

LC50

Carp, hawk fish (Cirrhinus mrigala)1.36 mg/l, 96 hours

Persistence and degradability

No data is available on the degradability of any ingredients in the mixture.

Bioaccumulative potential
Octanol/water partition coefficient log Kow
Prednisone
Sodium Dodecyl Sulfate Fine
No data available.
Mobility in soil
Other adverse effects

1.46
1.6

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 / unused
products

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).

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8 / 10Contaminated packaging

Since emptied containers may retain product residue, follow label warnings even after container is
emptied.

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 of
shipment.

15. Regulatory information
US federal regulations

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

Toxic Substances Control Act (TSCA)
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.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1053)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA 302 Extremely hazardous substanceNot listed.
SARA 311/312 Hazardous
chemicalClassified hazard
categories

Yes
Serious eye damage or eye irritation
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)

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
California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material
is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. For
more information go to www.P65Warnings.ca.gov.
International Inventories
Country(s) or region
Australia

Inventory name
Australian Inventory of Chemical Substances (AICS)

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)

No

Material name: Dissolution Performance Verification Standard - Prednisone1222818 Version #: 01 Issue date: 11-02-2022

On inventory (yes/no)*Yes

USP SDS US

9 / 10Country(s) or region
EuropeInventory nameEuropean List of Notified Chemical Substances (ELINCS)

On inventory (yes/no)*
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

TaiwanTaiwan Chemical Substance Inventory (TCSI)

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 governing
country(s).

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

11-02-2022

Version #01
USP materials are sold for analytical laboratory use only, and NOT for human consumption. The
information contained herein is applicable solely to the chemical substance when used foranalytical laboratory use and does not necessarily relate to any other use of the substancedescribed, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP
materials are intended for use by persons having technical skill and at their own discretion andrisk. This information has been developed by USP staff from sources considered reliable but has
not been independently verified by the USP. Therefore, the USP Convention cannot guarantee theaccuracy of the information in these sources nor should the statements contained herein beconsidered 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 contained herein.

Disclaimer

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