Atorvastatin 杂质C 693793-53-2(Difluoro impurity, or

Material Safety Data Sheet 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.ATTENTION !12601 Twinbrook Parkway, Rockville, MD 20852 USA Phone Calls:301-816-81298 a.m. to 5 p.m. EST Mon. - Fri.

ATORVASTATIN RELATED COMPOUND C Catalog Number:1044549Revision Date:February 5, 2009SECTION 2 - HAZARD INFORMATION

Common Name:Atorvastatin Calcium Related Compound C

SECTION 1 - PRODUCT AND COMPANY IDENTIFICATION

EMERGENCY OVERVIEW : Reproductive Hazard

Information on the chemical, physical, and toxicological properties of this material is not readily available. Individuals working with this chemical should consider it to be potentially hazardous, even if its actual hazards may be uncharacterized or unknown. For reference, available information on a related item, atorvastatin, is provided.

Adverse Effects:Adverse effects of statins such as atorvastatin calcium, a related compound, may include muscle pain, weakness,

stiffness, or tenderness; numbness or tingling in arms or legs; fever; unusual tiredness or weakness; headache;

dizziness; constipation; diarrhea; gas; heartburn or indigestion; stomach pain; nausea; skin rash; decreased sexual

ability; trouble sleeping; and upper respiratory infection. It is not known if this compound causes the same effects.

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

Overdose Effects:n/f

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

Chronic:Possible hypersensitization and liver damage.

Medical Conditions Aggravated by Exposure:Hypersensitivity to material; active liver disease or history of; active alcoholism;

unexplained, persistent elevations in transaminase values; severe electrolyte,

endocrine, or metabolic disorders; severe infection; myopathy; uncontrolled seizures;

organ transplant with immunosuppressant therapy; kidney impairment; and

amyotrophic lateral sclerosis (ALS).

Cross Sensitivity:Persons sensitive to HMG-CoA reductase inhibitors (e.g., fluvastatin, lovastatin, pravastatin) may be sensitive to this

material also.

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.

For additional information on toxicity, see Section 11.

SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS

Common Name:Atorvastatin Calcium Related Compound C

Formula:C33H33F2N2O5 . 1/2 Ca

Synonym:Atorvastatin calcium difluoro impurity

Chemical Name:(3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt

CAS:693793-53-2

RTECS Number:n/f

Chemical Family:n/f

Therapeutic Category:n/f

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. Flush with copious quantities of water.

Ingestion:May cause irritation. Flush out mouth with water.

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 statin overdose should be symptomatic and supportive and may include the following:

1. Administer activated charcoal as an aqueous slurry.

2. For rhabdomyolysis, administer 0.9% saline to maintain urine output of 2 - 3 milliliters/kg/hour. Monitor fluid

balance, serum electrolytes, CPK, liver enzymes, and renal function. Administer diuretics if needed to maintain

urine output. Urinary alkalinization is not recommended.

3. Hemodialysis is not expected to enhance clearance. [Poisindex 2009]

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.

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 labeled

container for disposal. Wash spill site.

SECTION 7 - HANDLING AND STORAGEHandling: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. Store in a dry place. Store in a refrigerator. This material is hygroscopic.

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:n/f

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 granular powder

Odor Threshold:n/f

pH:n/f

Melting Range:n/f

Boiling Point:n/f

Flash Point:n/f

Autoignition Temperature:n/f

Evaporation Rate:n/f

Upper Flammability Limit:n/f

Lower Flammability Limit:n/f

Vapor Pressure:n/f

Vapor Density:n/f

Specific Gravity:n/f

Solubility in Water:n/f

Fat Solubility:n/f

Other Solubility:n/f

Partition Coefficient: n-octanol/water:n/f

Percent Volatile:n/f

Reactivity in Water:n/f

Explosive Properties:n/f

Oxidizing Properties:n/f

Formula:C33H33F2N2O5 . 1/2 Ca

Molecular Weight:595.67

Oral Rat:n/f

Oral Mouse:n/f

NTP:No IARC:No OSHA:No

Listed as a Carcinogen by:

Irritancy Data:

n/f SECTION 11 - TOXICOLOGICAL PROPERTIES

Other Toxicity Data:n/f

Corrosivity:n/f Sensitization Data:n/f

Other Carcinogenicity Data:n/f

Mutagenicity Data:n/f Reproductive and Developmental Effects:Therapeutic use of statins such as atorvastatin calcium, a related compound, during

pregnancy is not recommended because they decrease cholesterol and may decrease

cholesterol-derived substances essential for fetal development. Results of animal studies

indicate that many statins are associated with adverse fetal outcomes at maternally toxic

doses. It is not known if this compound causes the same effects.SECTION 12 - ECOLOGICAL INFORMATION

Ecological Information:n/f SECTION 13 - DISPOSAL CONSIDERATIONS

Disposal:Dispose of waste in accordance with all applicable Federal, State, and local laws.SECTION 14 -TRANSPORT INFORMATION

Shipping Name:

n/f

Class:n/f

UN Number:n/f

Packing Group:n/f Additional Transport Information:n/f SECTION 15 - REGULATORY INFORMATION

U.S. Regulatory Information:n/f

International Regulatory Information:n/f SECTION 16 - OTHER INFORMATION

Stable?Yes Conditions to Avoid:Light, heat, and moisture.

Incompatibilities:n/f

Decomposition Products:When heated to decomposition, material emits toxic fumes of NOx and HF. Emits toxic fumes under fire

conditions.

Hazardous Polymerization?No SECTION 10 - STABILITY AND REACTIVITY

Previous Revision Date:15-Oct-08