Material Safety Data Sheet
12601 Twinbrook Parkway,
Rockville, MD 20852 USA
Phone Calls: 301-816-8129
8 a.m. to 5 p.m. EST Mon. - Fri.
ATTENTION !
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 other use of the substance
described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP Reference Standards are intended for use by persons having
technical skill and at 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 USP Convention cannot guarantee the accuracy of the information in these sources nor should the
statements 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 contained herein.
CAFFEINE
Catalog Number: 1085003
Revision Date:
December 19, 2006
SECTION 1 - PRODUCT AND COMPANY IDENTIFICATION
Common Name:
Caffeine
Manufacturer: U. S. Pharmacopeia
Responsible Party: Reference Standards Technical Services
Mailing Address: 12601 Twinbrook Parkway, Rockville, MD 20852 USA
Phone: 301-816-8129
Hours: 8 a.m. to 5 p.m. EST Mon. - Fri.
Product Use: USP Reference Standards and Authentic Substances are used for chemical tests and assays in analytical,
clinical, pharmaceutical, and research laboratories.
SECTION 2 - HAZARD INFORMATION
EMERGENCY OVERVIEW - Toxic.
Adverse Effects: Caffeine is naturally occurring in some beverages (such as coffee and tea) and, as a food additive, is generally
recognized as safe in small amounts. However, adverse effects may include nervousness, dizziness, trembling, nausea,
vomiting, diarrhea, fast heartbeat, increased urination, and trouble sleeping. Possible allergic reaction to material if
inhaled, ingested or in contact with skin.
Overdose Effects: Symptoms of overdose may include abdominal pain, nausea, vomiting (sometimes with blood), excitement, anxiety,
irritability, confusion or delirium, frequent urination, dehydration, fast or irregular heartbeat, fever, headache,
increased sensitivity to touch or pain, muscle twitching, ringing in ears, seeing flashes of light, trouble sleeping, rapid
breathing, cardiac arrest, and seizures. A single dose of between 5 and 10 grams may be fatal.
Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation.
Chronic: Possible hypersensitization; gastrointestinal, sensory, or cardiac disturbances; muscle tremor; insomnia; headache; mood or
mental changes; and habituation, psychological dependence, or tolerance.
Medical Conditions Aggravated by Exposure: Hypersensitivity to material, anxiety disorders, severe cardiac disease, impaired liver
function, hypertension, insomnia, or peptic ulcer.
Cross Sensitivity: Persons sensitive to other xanthines (aminophylline, dyphylline, oxtriphylline, theobromine, and theophylline) may be
sensitive to this material also.
Target Organs: Central nervous system, cardiovascular system
For additional information on toxicity, see Section 11.
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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CAFFEINE
Catalog Number: 1085003
Revision Date:
December 19, 2006
SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS
Common Name: Caffeine
Formula: C8H10N4O2
Synonym: 1,3,7-Trimethylxanthine
Chemical Name: 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethylCAS: 58-08-2
RTECS Number: EV6475000
Chemical Family: Methylated xanthine
Therapeutic Category: Stimulant (central)
Composition: Pure Material
SECTION 4 - FIRST AID MEASURES
Inhalation: May cause irritation. Remove to fresh air.
Eye: May cause irritation. Flush with copious quantities of water.
Skin: May cause irritation. Avoid contact. Flush with copious quantities of water. This material may be absorbed through the skin.
Ingestion: May cause irritation, bitter taste, and toxicity. Avoid ingestion. Flush out mouth with water. This material is readily absorbed
from the gastrointestinal tract.
General First Aid Procedures: 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.
Note to Physicians
Overdose Treatment: Treatment of overdose should be symptomatic and supportive and may include the following:
1. Do NOT induce vomiting.
2. Administer activated charcoal as a slurry.
3. For seizures, administer intravenous diazepam or lorazepam. If seizures recur, consider phenobarbital.
4. For gastrointestinal irritation in stable patients, administer liquid antacids, as needed.
5. Monitor fluid and electrolyte status and correct abnormalities. Hyperkalemia is common.
6. For rhabdomyolysis, ensure adequate hydration and urine output.
7. Treat life-threatening dysrhythmias and those that compromise hemodynamic status aggressively.
Dysrhythmias often respond to beta-blockers.
8. For ventricular dysrhythmias, institute continuous cardiac monitoring, obtain an ECG, and administer
oxygen. Evaluate for hypoxia, acidosis and electrolyte disorders. Lidocaine and amiodarone are first line agents
for stable monomorphic ventricular tachycardia, particularly in patients with underlying impaired cardiac
function. Sotalol is an alternative. Use amiodarone and sotalol with caution with prolongation of QT interval
and/or torsades de pointes. Unstable rhythms require cardioversion.
9. For severe tachycardia in hemodynamically unstable patients, treat with short acting cardioselective betablocker, like esmolol. Propranolol is an alternative.
10. For hypotension, infuse isotonic fluid. If hypotension persists, administer dopamine or norepinephrine.
11. Hemoperfusion is more effective than dialysis in enhancing elimination. [Meditext 2006]
SECTION 5 - FIREFIGHTING MEASURES
Extinguisher Media: Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.
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.
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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CAFFEINE
Catalog Number: 1085003
Revision Date:
December 19, 2006
SECTION 6 - ACCIDENTAL RELEASE MEASURES
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-labelled
container for disposal. Wash spill site.
SECTION 7 - HANDLING AND STORAGE
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, light-resistant container as defined in the USP-NF. This material should be handled and stored per label
instructions to ensure product integrity.
SECTION 8 - EXPOSURE CONTROL / PERSONAL PROTECTION
Engineering Controls: Engineering controls such as exhaust ventilation are recommended.
Respiratory Protection: Use a NIOSH-approved respirator, if it is determined to be necessary by an industrial hygiene survey
involving air monitoring. In the event that a respirator is not required, an approved dust mask should be used.
Gloves:
Chemically compatible
Eye Protection: Safety glasses or goggles
Protective Clothing: Protect exposed skin.
Exposure Limits: Industry: 200 micrograms/m3
SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES
Properties as indicated on the MSDS are general and not necessarily specific to the USP Reference Standard Lot provided.
Appearance and Odor: White crystalline powder or glistening needles; odorless.
Odor Threshold: n/f
pH: 5.5 - 6.5 (1% aqueous solution) at 20° C
Melting Range: 235 - 239° C
Boiling Point: 178° C (sublimes)
Flash Point: n/f
Autoignition Temperature: >600° C (DIN 51794)
Evaporation Rate: n/f
Upper Flammability Limit: n/f
Lower Flammability Limit: n/f
Vapor Pressure: 15 mmHg at 89° C
Vapor Density: n/f
Specific Gravity: 1.23
Solubility in Water: Sparingly soluble
Fat Solubility:
n/f
Other Solubility: Soluble in ethyl acetate; freely soluble in chloroform, in pyrrole, and in tetrahydrofuran containing 4% water; slightly
soluble in ether; sparingly soluble in alcohol
Partition Coefficient: n-octanol/water: -0.091 at 23° C
Percent Volatile: 0
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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CAFFEINE
Catalog Number: 1085003
Revision Date:
December 19, 2006
Reactivity in Water: n/f
Explosive Properties: n/f
Oxidizing Properties: n/f
Formula:
C8H10N4O2
Molecular Weight: 194.19
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
n/f = not found
Page 4 of 6
CAFFEINE
Catalog Number: 1085003
Revision Date:
December 19, 2006
SECTION 10 - STABILITY AND REACTIVITY
Conditions to Avoid: Avoid exposure to heat and light.
Strong oxidizers, iodine silver salts, tannins, strong caustic alkali solutions.
Incompatibilities:
Decomposition Products: When heated to decomposition material emits toxic fumes of NOx. Emits toxic fumes under fire conditions.
Stable? Yes
Hazardous Polymerization? No
SECTION 11 - TOXICOLOGICAL PROPERTIES
Oral Rat: LD50: 192 mg/kg
Oral Mouse:
LD50: 127 mg/kg
Other Toxicity Data: Oral Dog: LD50: 140 mg/kg
Irritancy Data:
Corrosivity:
Rabbit/skin: non-irritant; Rabbit/eye: non-irritant
n/f
Sensitization Data: n/f
Listed as a Carcinogen by:
NTP: No
IARC:
No
OSHA: No
Other Carcinogenicity Data: Caffeine is not classifiable as to its carcinogenicity in humans.
No increase in tumor incidence was found in rats administered caffeine in drinking water for two years at
doses up to 102 mg/kg (males) or up to 170 mg/kg (females). There is a weak positive relationship
between consumption of coffee (which contains caffeine) and the occurrence of bladder cancer.
Mutagenicity Data:
Salmonella and classic E. coli studies were negative in most mutagenicity tests. Special E. coli strains and
Saccharomyces showed positive results. In terms of gene mutation in mammalian cell cultures and UDS assays,
the results were consistently negative. Only at high doses were some indications of clastogenic activity in cell lines
found. In the majority of in vivo tests (micronucleus test, chromosome abberation assay, dominant lethal assay,
and host-mediated assay), negative results were obtained in terms of mutagenicity and clastogenicity. On the
whole, the conclusion is drawn that under exposure relavant conditions there are no indications of genotoxicity of
caffeine. [Organization for Economic Co-operation and Development, OECD, 2002]
Reproductive and Developmental Effects: Human developmental toxicity studies have had mixed results. Some studies have shown
abnormal cardiac and neurological function, increased miscarriages and stillbirths, and
birth defects; while others have found no adverse human reproductive effects from caffeine
consumption. Groups such as OTIS, March of Dimes, and Motherisk reviewed studies
examining caffeine intake during pregnancy and are in agreement that high caffeine intake
(>300 mg/day, equivalent to more than 3 cups of coffee/day) should be avoided during
pregnancy. There is also general agreement that low caffeine intake (<150 mg/day, about 1
1/2 cups of coffee) during pregnancy is not likely to harm the unborn child. However,
there is some disagreement regarding moderate caffeine intake. [Center for the Evaluation
of Risks to Human Reproduction, 2005]
SECTION 12 - ECOLOGICAL INFORMATION
Ecological Information: This material is moderately toxic to aquatic organisms.
This material is poorly biodegradable and has a low bioaccumulation potential.
SECTION 13 - DISPOSAL CONSIDERATIONS
Disposal:
Dispose of waste in accordance with all applicable Federal, State and local laws.
SECTION 14 -TRANSPORT INFORMATION
Shipping Name:
Alkaloids, solid, n.o.s. (Caffeine)
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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CAFFEINE
Catalog Number: 1085003
Class:
Revision Date:
December 19, 2006
6.1
UN Number: UN1544
Packing Group:
III
Additional Transport Information: n/f
SECTION 15 - REGULATORY INFORMATION
U.S. Regulatory Information:
n/f
International Regulatory Information: EINECS # 200-362-1
Hazard Code: Xn
Risk Phrases: R22
SECTION 16 - OTHER INFORMATION
Revision:
19-Dec-06
Previous Revision Date:
30-Jul-04
Copyright © 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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