泰诺-USP说明书

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: 301-816-8129 8 a.m. to 5 p.m. EST Mon. - Fri. TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 SECTION 2 - HAZARD INFORMATION Common Name: Tenofovir Disoproxil Fumarate SECTION 1 - PRODUCT AND COMPANY IDENTIFICATION SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS EMERGENCY OVERVIEW : Irritant Adverse Effects: Adverse effects may include rash, diarrhea, headache, depression, nausea, abdominal pain, gas, vomiting, fatigue, dizziness, lack of strength, and loss of appetite. 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, lactic acidosis and liver damage. Medical Conditions Aggravated by Exposure: Hypersensitivity to material, liver disease, kidney impairment, and bone problems. Cross Sensitivity: n/f Target Organs: n/f For additional information on toxicity, see Section 11. Common Name: Tenofovir Disoproxil Fumarate Formula: C19H30N5O10P . C4H4O4 Synonym: n/f 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. Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 1 of 6 TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 SECTION 6 - ACCIDENTAL RELEASE MEASURES SECTION 5 - FIREFIGHTING MEASURES SECTION 4 - FIRST AID MEASURES Extinguisher Media: Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials. Firefighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. 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. SECTION 7 - HANDLING AND STORAGE Chemical Name: 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1) CAS: 202138-50-9 RTECS Number: SZ6563700 Chemical Family: n/f Therapeutic Category: Nucleotide analog HIV-1 reverse transcriptase and HBV polymerase inhibitor Composition: Pure Material Inhalation: May cause irritation. Remove to fresh air. Eye: Causes severe irritation. Flush with copious quantities of water for at least 15 minutes. Skin: May cause irritation. Flush with copious quantities of soap and water. Ingestion: May cause irritation. Flush out mouth with water. General First Aid Procedures: Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider familiar with workplace chemical 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, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. Note to Physicians Overdose Treatment: Treatment of tenofovir overdose should be symptomatic and supportive and may include the following: 1. Administer activated charcoal as a slurry. 2. For seizures, administer benzodiazepine IV. Consider phenobarbital or propofol if seizures recur. Monitor for hypotension, dysrthymias, respiratory depression, and need for endotracheal intubation. Evaluate for hypoglycemia, electrolyte disturbances, hypoxia. 3. Severe metabolic acidosis should be corrected with IV sodium bicarbonate. Monitor blood gases to guide bicarbonate therapy. Riboflavin and L-carnitine should be used to treat patients with lactic acidosis associated with nucleoside analogs. 4. Monitor complete blood counts, serum electrolytes, renal and liver function tests, pancreatic enzymes and CPK, and peripheral neuropathy. Cardiac monitoring is recommended. [Meditext, 2009] 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. 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. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly. Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 2 of 6 TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 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. Respiratory Protection: Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Gloves: Chemically compatible. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. This material is extremely irritating to skin. To reduce the risk of contamination of skin and surfaces, wear two pairs of gloves. Remove the outer gloves after handling and cleanup of the material, and remove the inner gloves only after removing other personal protective equipment. Eye Protection: Safety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area. Protective Clothing: For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take-home contamination. SECTION 8 - EXPOSURE CONTROL / PERSONAL PROTECTION SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Melting Range: n/f Boiling Point: n/f Specific Gravity: n/f Vapor Pressure: n/f Vapor Density: n/f Solubility in Water: Sparingly soluble Appearance and Odor: White to off-white crystalline powder; odorless. Evaporation Rate: n/f Engineering Controls: Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials. Avoid any open handling of this material, particularly for grinding, crushing, weighing, or other dust-generating or aerosol-generating procedures. Use a laboratory fume hood, vented enclosure, glovebox, or other effective containment. Exposure Limits: n/f Properties as indicated on the MSDS are general and not necessarily specific to the USP Reference Standard Lot provided. Odor Threshold: n/f pH: n/f Flash Point: n/f Upper Flammability Limit: n/f Lower Flammability Limit: n/f Fat Solubility: n/f Autoignition Temperature: >200 ° C Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 3 of 6 TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 Percent Volatile: n/f Reactivity in Water: n/f Other Solubility: Freely soluble in dimethylformamide; soluble in methanol, in acid hydrochloride (0.1 N HCL), and in ethanol; sparingly soluble in acetone and in isopropanol; slightly soluble in acetonitrile and in ethyl acetate; insoluble in dichloromethane, in hexane, in diethyl ether, in di-n-butyl ether, and in isopropylether. Partition Coefficient: n-octanol/water: Explosive Properties: n/f Oxidizing Properties: n/f Molecular Weight: 635.51 Formula: C19H30N5O10P . C4H4O4 Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 4 of 6 TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 Oral Rat: LD50: >950 mg/kg Oral Mouse: n/f NTP: No IARC: No OSHA: NoListed as a Carcinogen by: Irritancy Data: Eye/rabbit: severe Skin/rabbit: slight SECTION 11 - TOXICOLOGICAL PROPERTIES Other Toxicity Data: n/f Corrosivity: n/f Sensitization Data: Skin/guinea pig: not a contact sensitizer Other Carcinogenicity Data: Long-term oral carcinogenicity studies of tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to approximately 16 times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV-1 infection. At the high dose in female mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic findings at exposures up to 5 times that observed in humans at the therapeutic dose. Mutagenicity Data: Tenofovir disoproxil fumarate was mutagenic in an in-vitro mouse L5178Y lymphoma cell assay and in ex-vivo assay for unscheduled DNA synthesis in rat hepatocytes, but it was negative in in-vitro bacterial assays for gene mutation and an in-vivo mouse micronucleus test for chromosomal damage. Reproductive and Developmental Effects: Reproduction studies have been performed in rats and rabbits at doses higher than 600 mg/kg/day and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir. In pregnancy exposure studies to tenofovir in the first trimester, no increases in birth defects have been observed. 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 Stable? Yes Conditions to Avoid: Heat Incompatibilities: n/f Decomposition Products: When heated to decomposition, material emits toxic fumes of NOx. Emits toxic fumes under fire conditions. Hazardous Polymerization? No SECTION 10 - STABILITY AND REACTIVITY Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 5 of 6 TENOFOVIR DISOPROXIL FUMARATE Catalog Number: 1643656 Revision Date: December 2, 2009 International Regulatory Information: n/f SECTION 16 - OTHER INFORMATION Revision: 02-Dec-09 Previous Revision Date: 20-May-09 Copyright © 2010 The United States Pharmacopeial Convention, Inc. All Rights Reserved. n/f = not found Page 6 of 6