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Capecitabine msds

The material safety data sheet (MSDS) of Capecitabine
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  • Company Profile

    The material safety data sheet (MSDS) is one important component for product stewardship and workplace safety. You could refer to its for more detailed product information. And Capecitabine msds below is provided by Nanjing Aily Biotechnology Co.,Ltd., which is one leading Capecitabine product producer and experienced in chemical manufacturing and custom synthesis. 

    Capecitabine

    1. Product and Company Identification

    Product name: Capecitabine

    2. Composition/Information on ingredients


    Characterization: pharmaceutical active substance in the group of fluorinated
    cytosines
    Chemical name:- 5’-Deoxy-5-fluoro-N4-pentyloxycarbonyl-cytidine
    Synonyms- XELODA
                   - NeoFurtulon successor
                   - N-[1-(5-Deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl]-n-pentyl carbamate
    CAS number: 154361-50-9
    UN number: 3077
    Roche number: Ro0091978-000
    Empirical formula: C15H22FN3O6

    3. Hazards identification

    Most important hazards
    - Irritating to eyes and skin.
    - May cause cancer.
    - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
    - May cause harm to the unborn child.

    Note
    - Cytostatics in general have to be classified as potentially carcinogenic, teratogenic and mutagenic. During handling any occupational exposure as well as environmental contamination have to be avoided.

    4. First-aid measures

    Eye contact
    - rinse immediately with tap water for 10 minutes - open eyelids forcibly
    - consult a physician if irritation persists

    Skin contact
    - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents
    - consult a physician if skin irritation persists

    Inhalation
    - remove the casualty to fresh air and keep him/her calm
    - consult physician

    Ingestion
    - summon a physician immediately
    - let drink repeatedly plenty of water and induce vomiting (only if conscious), repeat several times

    Note to physician
    - treat symptomatically
    - in case of accidental exposure, keep a sample of urine in order to determine the content of fluoro-β-alanine

    5. Fire-fighting measures

    Suitable extinguishing media
    - water spray jet, dry powder, foam, carbon dioxide

    Specific hazards
    - formation of toxic and corrosive combustion gases (hydrogen fluoride, nitrogen oxides) possible
    - consider danger for the environment: dike spilled liquid
    - consider dust explosion hazard

    Protection of fire-fighters
    - precipitate gases/vapours/mists with water spray
    - use self-contained breathing apparatus
    - avoid skin contact

    6. Accidental release measures

    Personal precautions
    - evacuate area, remove sources of ignition, ventilate
    - keep people away and stay on the upwind side

    Environmental protection
    - avoid release to the environment

    Methods for cleaning up
    -- collect spilled material (avoid dust formation) and hand over to waste removal in sealed containers
    - clean floors and contaminated objects with plenty of water
    - collect spilled solutions with inert adsorbent and hand over to waste removal

    7. Handling and storage

    Handling
    Technical measures
    - processing in closed systems, if possible superposed by inert gas (e.g. nitrogen)
    - local exhaust ventilation necessary
    - avoid dust formation; very high dust explosion hazard
    - take precautionary measures against electrostatic charging

    Storage
    Storage conditions
    - room temperature
    - store in a dry place

    Validity
    - 24 months, at room temperature
    - see expiry date on the label

    Packaging materials
    - tightly closing; material: stainless steel, aluminium, enamel, glass, plastic

    8. Exposure controls/Personal protection

    Engineering Measures
    - see 7.

    Monitoring Threshold value (Roche) air
    - IOEL (Internal Occupational Exposure Limit): 0.01 mg/m3 (definedas 8-hour time-weighted average)

    Personal protective equipment

    Respiratory protection
    - in case of open handling or accidental release: particle mask or respirator with independent air supply

    Hand protection
    - protective gloves (eg made of neoprene, nitrile or butyl rubber

    Eye protection
    - safety glasses

    Body protection
    - protective clothing

    General protective and hygiene measures
    - instruction of employees mandatory
    - shower after work recommended

    9. Physical and chemical properties

    Colour: white to light yellow

    Form: powder

    Odour: odourless

    Bulk density: ~ 0.2 g/cm3

    Solubility:
    26’000 mg/l, water (20 °C)
    207’000 mg/l, ethanol (20 °C)
    > 40 %, methanol
    11.8 %, acetonitrile
    > 59 %, dimethyl formamide
    2.5 %, ethyl acetate
    Partition coefficient: log Pow ~ 4.5 (n-octanol/water) pH 7.4

    Dissociation constant: pK1 =8.8 (acidic group(s))

    Melting temperature: 116 to 117 °C

    10. Stability and reactivity

    Stability
    - stable under the conditions mentioned in chapter 7

    Conditions to avoid
    - temperatures above 100 °C (decomposition)

    Materials to avoid
    - strong acids (hydrolysis)

    11. Toxicological information

    Sensitization
    - slightly sensitizing (several species)

    Subchronic toxicity
    - high doses may damage proliferating cells (e.g., bone marrow,
    leukocytes)

    Mutagenicity
    - may cause mutations in vitro (clastogenic effect in lymphocytes)
    - lymphocyte test; evidence of clastogenicity

    Reproduction toxicity
    - suspected to be teratogenic and to lower parental fertility
    - decreased weight of testis and epididymis, decrease and
    degeneration of spermatocytes and spermatids (760 mg/kg/d;
    oral, mouse, male)
    - reduced mating ability and fertility rate (760 mg/kg/d; oral, mouse,
    female)

    NOTE
    - may cause diarrhoea, nausea, vomiting, loss of appetite, irritation of mucous membranes and alteration of the haemopoietic system (leukopenia) in dependance of the dose
    - cytostatics are potentially carcinogenic

    12. Ecological information

    Inherent biodegradability
    - inherently biodegradable evidence for prior abiotic primary degradation as a rate-limiting process
    29 %, 28 d
    44 %, 56 d
    55 %, 84 d
    (MITI Test II, OECD No. 302 C)

    Abiotic degradation
    - slow degradation, probably ester hydrolysis (30 mg/l; HPLC)
    t1/2 ~ 21 d, ~ 22 °C, pH ~ 7
    - rapid degradation only at very acidic pH (1000 mg/l, water; HPLC)
    t1/2 ≥ 60 h, ~ 22 °C, pH 2
    t1/2 ~ 6 h, ~ 22 °C, pH 1
    t1/2 < 2 h, ~ 22 °C, pH 0.5
    t1/2 ~ 1 h, 30 °C, pH 0.5

    Ecotoxicity
    - strongly toxic for algae (Selenastrum capricornutum)
    EbC50 (72 h) 0.58 mg/l
    ErC50 (72 h) 2.0 mg/l
    NOEC (72 h) 0.14 mg/l
    (OECD No. 201)
    - barely toxic for planktonic crustaceans (Daphnia magna)
    EC50 (48 h) > 850 mg/l
    NOEC (48 h) 500 mg/l
    - barely toxic for fish (rainbow trout)
    LC50 (96 h) > 867 mg/l
    NOEC (96 h) 867 mg/l
    - barely inhibitory on aerobic bacterial respiration
    EC50 > 1000 mg/l
    (Activated Sludge Respir. Inhib. Test, OECD No. 209)

    Mobility
    - medium adsorption to activated sludge, medium mobility (water-activated sludge, 3 h)Kd = 272 l/kg (activated sludge)(Adsorption to activated sludge in biodegradability test)

    Note
    - strictly avoid contamination of the environment

    13. Disposal considerations

    Waste from residues
    - observe local/national regulations regarding waste disposal
    - incinerate in qualified installation with flue gas scrubbing

    14. Other information

    Use
    - pharmaceutical active substance (cytostatic)

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