رفرنس استاندارد بکلومتازون دی پروپیونات Beclomethasone dipropionate 1048506

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1048506

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Beclomethasone dipropionate

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United States Pharmacopeia (USP) Reference Standard

Synonym(s):9-Chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionateEmpirical Formula (Hill Notation):C28H37ClO7CAS Number:5534-09-8Molecular Weight:521.04MDL number:MFCD00135613PubChem Substance ID:329749099NACRES:NA.24

Beclomethasone Dipropionate (200 mg)

Catalog No:1048506CAS RN®5534-09-8Molecular Formula:C28H37ClO7Product Type:Reference Standard

Current Lot Information

• Current Lot: R066J0
• CAS RN® 5534-09-8
• Harmonized System (HS) Code *: 293722
• UN No: N/A
• NDC No: N/A
• Molecular Formula: C28H37ClO7
• Container Type: VIAL
• Base Control Substance (substance %): N/A

Product InformationSDS: Safety data sheet.pdfUSP Certificates/Product Information Sheets and Valid Use DatesLot NoUSP Certificate or Product Information SheetValid Use DateCountry of Origin*Material Origin *R066J0 (Current)1048506 - R066J0CurrentItalyChemical SynthesisM0L2761048506 - M0L27631-JAN-2019PortugalChemical SynthesisL0D3121048506 - L0D31230-JUN-2014United KingdomChemical SynthesisKNot Available28-FEB-2006PortugalChemical SynthesisJNot Available31-DEC-2000PortugalChemical Synthesis* Certain Material Origins (i.e. Animal, Plant, Fish) may require special country importation requirements. USP recommends you contact your country competent authorities to determine if any certifications, permits or licenses may be required prior to ordering. Material Origins are found within the Product under Origin Information.*Disclaimer:* The Harmonized System (HS) code provided on this webpage is for informational purposes only and is subject to change without notice. The exporter and/or importer of record is responsible for determining the accuracy of items at the time of export/import per U.S. regulations. USP is not responsible for the accuracy or completeness of the information furnished.* USP procures materials worldwide and most foreign materials do not undergo a fundamental change during the packaging process at USP that would substantially transform the item resulting in a country of origin change from the foreign origin to the United States. Under the Rules of Origin the original foreign country of origin would remain.

1. Identification Product identifier Beclomethasone Dipropionate Other means of identification Catalog number 1048506 CAS number 5534-09-8 Synonyms Beclomethasone 17,21-dipropionate Pregna-1,4-diene-3,20-dione, 9-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)- Chemical name 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 U. S. Pharmacopeia Address 12601 Twinbrook Parkway Company name MD 20852-1790 Website Telephone RS Technical Services 301-816-8129 Emergency phone number CHEMTREC within US & Canada 1-800-424-9300 CHEMTREC outside US & Canada +1 703-527-3887 E-mail United States www.usp.org RSTECH@usp.org Rockville 2. Hazard(s) identification Physical hazards Not classified. Health hazards Reproductive toxicity Category 2 Specific target organ toxicity, repeated Category 1 (endocrine system) exposure Environmental hazards Not classified. OSHA defined hazards Not classified. Label elements Signal word Danger Hazard 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 read and 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 exposed or concerned: Get medical advice/attention. Get medical advice/attention if you feel unwell. Storage Store locked up. Disposal Dispose of contents/container in accordance with local/regional/national/international regulations. 1 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Hazard(s) not otherwise classified (HNOC) None known. Supplemental information Potent pharmacologically active material. 3. Composition/information on ingredients Substance Chemical name Common name and synonyms CAS number % Beclomethasone Dipropionate Beclomethasone 17, 21- dipropionate 5534-09-8 100 4. First-aid measures 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. Inhalation Skin contact 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. Endocrine system effects. Potent pharmacologically active material. Occupational exposure to small amounts may cause physiological effects. Most important symptoms/effects, acute and delayed Provide general supportive measures and treat symptomatically. Treatment of corticosteroid overdose may include the following: Toxicity is low after acute ingestion. Gastrointestinal decontamination is generally not necessary. Indication of immediate medical attention and special treatment needed 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. General information 5. Fire-fighting measures Water. Foam. Dry chemical or CO2. Use fire-extinguishing media appropriate for surrounding materials. Suitable extinguishing media Unsuitable extinguishing None known. media Specific hazards arising from No unusual fire or explosion hazards noted. the chemical Special protective equipment Wear suitable protective equipment. and precautions for firefighters 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. Fire fighting equipment/instructions Use standard firefighting procedures and consider the hazards of other involved materials. Cool containers exposed to flames with water until well after the fire is out. Specific methods General fire hazards No unusual fire or explosion hazards noted. 6. Accidental release measures 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. Personal precautions, protective equipment and emergency procedures 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. Methods and materials for containment and cleaning up Environmental precautions Avoid discharge into drains, water courses or onto the ground. 7. Handling and storage 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. Select and use containment devices and personal protective equipment based on a risk assessment of material potency and exposure potential. Precautions for safe handling 2 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Store in tight container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. Conditions for safe storage, including any incompatibilities 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 Type Value Beclometha sone TWA 6 micrograms/m3 Dipropiona te (CAS 5534-09-8) Biological limit values No biological exposure limits noted for the ingredient(s). No open handling. For laboratory operations, use approved ventilation or containment system (biological safety cabinet, ventilated balance enclosure, glovebox). Control exposures to below the occupational exposure level (if available). Select and use containment devices and personal protective equipment based on a risk assessment of exposure potential. Cover all containers for solutions and slurries while being transferred. Appropriate engineering controls Individual protection measures, such as personal protective equipment Wear safety glasses with side shields, chemical splash goggles, or full face shield, if necessary. 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. Eye/face protection Skin protection Consider double gloves. Wear nitrile or other impervious gloves if skin contact is possible. When the material is dissolved or suspended in an organic solvent, wear gloves that provide protection against the solvent. Hand protection 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 of skin 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. Other 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 of existing engineering controls. Respiratory protection Thermal hazards Wear appropriate thermal protective clothing, when necessary. Handle in accordance with good industrial hygiene and safety practice. 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 or quantities should be determined after an appropriate assessment. General hygiene considerations 9. Physical and chemical properties Appearance Appearance descriptions are general information and not specific to any USP lot. Physical state Solid. Form Powder. Color White. Cream. Odor Odorless. Odor threshold Not available. pH Not available. Melting point/freezing point 393.8 - 406.4 °F (201 - 208 °C) (decomposes) Initial boiling point and boiling range Not available. Flash point Not available. Evaporation rate Not available. Flammability (solid, gas) Not available. Upper/lower flammability or explosive limits Flammability limit - lower (%) Not available. 3 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Flammability limit - upper (%) Not available. Explosive limit - lower (%) Not available. Explosive limit - upper (%) Not available. Vapor pressure < 0.0000001 kPa at 25 °C Vapor density Not available. Relative density Not available. Solubility(ies) Solubility (water) Very slightly soluble. Solubility (other) Acetone: Freely soluble. Chloroform: Very soluble. Alcohol: Freely soluble. Partition coefficient (n-octanol/water) 3.49 Auto-ignition temperature Not available. Decomposition temperature Not available. Viscosity Not available. Other information Chemical family Corticosteroid. Molecular formula C28H37ClO7 Molecular weight 521.04 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 No dangerous reaction known under conditions of normal use. reactions Conditions to avoid Contact with incompatible materials. Incompatible materials Strong oxidizing agents. Hazardous decomposition Cl-. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. products 11. Toxicological information Information on likely routes of exposure Inhalation Based on information from therapeutic use, this material may cause: Endocrine effects. Skin contact Knowledge about health hazard is incomplete. Eye contact Knowledge about health hazard is incomplete. Ingestion Knowledge about health hazard is incomplete. Symptoms related to the physical, chemical, and toxicological characteristics 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. Menstrual irregularities. Impotence. Information on toxicological effects Acute toxicity Product Species Test Results Beclomethasone Dipropionate (CAS 5534-09-8) Inhalation Acute LC50 Rat > 51.6 mg/l, 2 hours Oral LD50 Mouse > 5 g/kg Rat > 3750 mg/kg 4 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Skin corrosion/irritation Knowledge about health hazard is incomplete. Serious eye damage/eye Knowledge about health hazard is incomplete. irritation Respiratory or skin sensitization Respiratory sensitization Knowledge about health hazard is incomplete. Skin sensitization Knowledge about health hazard is incomplete. Germ cell mutagenicity Knowledge about mutagenicity is incomplete. Mutagenicity Micronucleus test Result: Negative. Species: Mouse Mutagenicity: Chinese hamster ovary cells Result: Negative. Carcinogenicity Based on available data, the classification criteria are not met. Carcinogenicity, administered orally and by inhalation Result: Negative. Species: Rat Test Duration: 95 weeks IARC Monographs. Overall Evaluation of Carcinogenicity Not listed. 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 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 signs of hypoadrenalism. Reproductive toxicity Reproductivity 0.1 mg/kg/day Reproductivity / Developmental, administered subcutaneously Result: Birth defects and fetal death. Species: Mouse 0.25 mg/kg/day Reproductivity / Developmental, administered subcutaneously Result: Birth defects and fetal death. Species: Rabbit 0.33 mg/kg/day Fertility study, administered by inhalation Result: No impaired fertility. Species: Dog 0.5 mg/kg/day Fertility study, administered orally Result: Impaired fertility. Species: Dog 15 mg/kg/day Reproductivity / Developmental, administered by inhalation Result: No birth defects or fetal death. Species: Rat Reproductivity / Developmental; administered orally in mice and rats Result: Birth defects including cleft palate. 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 The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment. Ecotoxicity 5 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Persistence and degradability Not readily biodegradable. Bioaccumulative potential Octanol/water partition coefficient log Kow 3.49 Mobility in soil No data available. 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 Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria for hazardous waste. Disposal instructions Local disposal regulations 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. Hazardous waste code 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). Waste from residues / unused products 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 is emptied. Contaminated packaging 14. Transport information DOT Not regulated as dangerous goods. IATA Not regulated as dangerous goods. Transport in bulk according to Not applicable. Annex II of MARPOL 73/78 and the IBC Code It is the shipper's responsibility to determine the correct transport classification at the time of shipment. General information 15. Regulatory information This product is a "Hazardous Chemical" as defined by the OSHA Hazard Communication Standard, 29 CFR 1910.1200. US federal regulations 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 1910.1001-1050) Not regulated. Superfund Amendments and Reauthorization Act of 1986 (SARA) Immediate Hazard - No Delayed Hazard - Yes Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No Hazard categories SARA 302 Extremely hazardous substance Not listed. SARA 311/312 Hazardous Yes chemical SARA 313 (TRI reporting) Not regulated. Other federal regulations Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List Not regulated. 6 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010 USP SDS US Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130) Not regulated. Safe Drinking Water Act Not regulated. (SDWA) US state regulations US - California Proposition 65 - CRT: Listed date/Developmental toxin Beclomethasone Dipropionate (CAS 5534-09-8) Listed: May 15, 1998 US. California. Candidate Chemicals List. Safer Consumer Products Regulations (Cal. Code Regs, tit. 22, 69502.3, subd. (a)) Beclomethasone Dipropionate (CAS 5534-09-8) International Inventories Country(s) or region Inventory name On inventory (yes/no)* Australia Australian Inventory of Chemical Substances (AICS) Yes Canada Domestic Substances List (DSL) Yes Canada Non-Domestic Substances List (NDSL) No China Inventory of Existing Chemical Substances in China (IECSC) No Europe European Inventory of Existing Commercial Chemical Yes Substances (EINECS) Europe European List of Notified Chemical Substances (ELINCS) No Japan Inventory of Existing and New Chemical Substances (ENCS) No Korea Existing Chemicals List (ECL) No New Zealand New Zealand Inventory Yes Philippines Philippine Inventory of Chemicals and Chemical Substances Yes (PICCS) United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No *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 07-30-2010 Revision date 11-15-2018 Version # 03 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. Disclaimer 7 / 7 Material name: Beclomethasone Dipropionate 1048506 Version #: 03 Revision date: 11-15-2018 Issue date: 07-30-2010