Scribd Logo
Upload

Welcome to Scribd!

  • 40 views

    Yttrium Y 90 Ibritumomab Tiuxetan Injection

    Uploaded by

    Kasidit Sornchai
    1) Yttrium Y 90 Ibritumomab Tiuxetan Injection is a sterile, nonpyrogenic preparation of the immunoconjugate of ibritumomab and tiuxetan that is labeled with 90Y and is suitable for intravenous administration. 2) It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 90Y as the ibritumomab complex, expressed in megabecquerels (or millicuries) per mL at the time indicated in the labeling. 3) The Injection meets requirements for injectable drug products and radioactive components except that sterility testing may begin on the date of manufacture rather than

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Yttrium Y 90 Ibritumomab Tiuxetan Injection

    Uploaded by

    Kasidit Sornchai
    40 views1 page
    1) Yttrium Y 90 Ibritumomab Tiuxetan Injection is a sterile, nonpyrogenic preparation of the immunoconjugate of ibritumomab and tiuxetan that is labeled with 90Y and is suitable for intravenous administration. 2) It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 90Y as the ibritumomab complex, expressed in megabecquerels (or millicuries) per mL at the time indicated in the labeling. 3) The Injection meets requirements for injectable drug products and radioactive components except that sterility testing may begin on the date of manufacture rather than

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    1) Yttrium Y 90 Ibritumomab Tiuxetan Injection is a sterile, nonpyrogenic preparation of the immunoconjugate of ibritumomab and tiuxetan that is labeled with 90Y and is suitable for intravenous administration. 2) It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 90Y as the ibritumomab complex, expressed in megabecquerels (or millicuries) per mL at the time indicated in the labeling. 3) The Injection meets requirements for injectable drug products and radioactive components except that sterility testing may begin on the date of manufacture rather than

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    40 views1 page

    Yttrium Y 90 Ibritumomab Tiuxetan Injection

    Uploaded by

    Kasidit Sornchai
    1) Yttrium Y 90 Ibritumomab Tiuxetan Injection is a sterile, nonpyrogenic preparation of the immunoconjugate of ibritumomab and tiuxetan that is labeled with 90Y and is suitable for intravenous administration. 2) It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 90Y as the ibritumomab complex, expressed in megabecquerels (or millicuries) per mL at the time indicated in the labeling. 3) The Injection meets requirements for injectable drug products and radioactive components except that sterility testing may begin on the date of manufacture rather than

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 1

    Printed on: Tue Aug 03 2021, 07:35:59 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-560A332F-4F03-46CB-A198-B0E8DE7DD778_3_en-US

    (EST)
    Printed by: Le Tran Official Date: Official as of 01-May-2018 Document Type: USP @2021 USPC
    1

    Radionuclide identification (see Radioactivity á821ñ)—


    Yttrium Y 90 Ibritumomab Tiuxetan A: The beta radiation of the Injection shows a mass
    Injection absorption coefficient within 5% of the value found for a
    known standard of the 90Y when tested under the same
    counting conditions.
    » Ibritumomab Tiuxetan is the immunoconjugate B: The beta-ray spectrum, obtained on an energy
    resulting from a stable thiourea covalent bond calibrated beta spectrometer, is identical to that of the
    between the monoclonal antibody ibritumomab spectrum of 90Y of known purity, showing a maximum beta
    particle energy (E max) at about 2280 keV. [NOTE—Because of
    and the linker-chelator tiuxetan
    the inherent difficulty in measuring beta radiation, a second
    [N-[2-bis(carboxymethyl)amino]- comparative test should be performed.]
    3-(p-isothiocyanatophenyl) Bacterial Endotoxins Test á85ñ—The limit of endotoxin
    propyl]-[N-[2-bis(carboxymethyl)amino]- content is not more than 175/V USP Endotoxin Units per mL
    2-(methyl)ethyl)glycine. This chelate provides a of the Injection, when compared with the USP Endotoxin RS,
    high-affinity, conformationally restricted chelation in which V is the maximum recommended total dose, in mL,
    at the expiration date or time.
    site for 90Y and 111In. The approximate molecular pH á791ñ: between 5.5 and 7.5.
    weight of Ibritumomab Tiuxetan is 148 kD.
    Radiochemical purity—
    Ibritumomab is a murine IgG1 kappa monoclonal Adsorbent: 1- × 8-cm instant silica gel strip.
    antibody directed against the CD20 antigen, Test solution: the Injection.
    which is found on the surface of normal and Application volume: 10 µL.
    malignant B lymphocytes. Ibritumomab is Developing solvent system: 0.9% sodium chloride solution.

    al
    produced in Chinese hamster ovary cells and is Procedure—Proceed as directed for Thin-Layer
    Chromatography under Chromatography á621ñ by ascending
    composed of two murine gamma 1 heavy chains chromatography. Determine the distribution of radioactivity
    of 445 amino acids each and two kappa light on the chromatogram by scanning with a suitable collimated
    chains of 213 amino acids each. ci radiochromatogram strip scanner, and determine the
    Yttrium Y 90 Ibritumomab Tiuxetan Injection is a percentage of radiochemical purity of the test specimen. Not
    less than 95% of the 90Y activity is present as a band between
    sterile, nonpyrogenic preparation of the the R F values of 0.0 and 0.1.
    immunoconjugate of ibritumomab and tiuxetan Radionuclidic purity (Content of 90Sr in an yttrium Y
    that is labeled with 90Y and is suitable for 90 chloride solution) (see Radioactivity á821ñ)—Prepare a
    ffi
    intravenous administration. It contains not less strontium/yttrium carrier solution containing 0.34 mg of
    than 90.0 percent and not more than 110.0 yttrium chloride (YCl3 · 6H2O) and 0.30 mg of strontium
    percent of the labeled amount of 90Y as the chloride (SrCl2 · 6H2O) per mL of 0.1 N hydrochloric acid.
    Apply about 50 µL of this solution at the origin of a 2- × 19-cm
    ibritumomab complex, expressed in cellulose phosphate chromatographic strip (see
    megabecquerels (or millicuries) per mL at the time Chromatography á621ñ), and allow to dry. Apply about 5 µL of
    O

    indicated in the labeling. It may contain buffers and the yttrium Y 90 chloride radiolabeling solution at the origin,
    stabilizers. It contains no antimicrobial agents. and develop the chromatogram by ascending
    Other chemical forms of radioactivity do not chromatography over a period of about 1.25 hours, using 3 N
    hydrochloric acid as the developing solvent, until the solvent
    exceed 5 percent of the total radioactivity. The front migrates to the 15-cm mark. Allow to dry. Cut the strip
    immunoreactive fraction, as determined by a at the 8-cm mark, and place the upper section (solvent front)
    validated method, is not less than 90 percent. in a suitable liquid scintillation solvent. Using a suitable
    counting assembly, determine the radioactivity, in KBq (or
    Packaging and storage—Preserve in single-dose µCi) per mL of yttrium Y 90 chloride solution. The total
    containers, and store in a refrigerator for not more than 8 radioactivity of 90Sr is not greater than 740 KBq per 37 GBq
    hours. [NOTE—Translucent protein particles may develop, (or 20 µCi per Ci) of 90Y at the expiration date as stated on the
    which are removed by filtration prior to administration using a labeling.
    0.22-µm low-protein-binding filter.] Other requirements—It meets the requirements under
    Labeling—Label it to include the following in addition to the Injections and Implanted Drug Products á1ñ, except that the
    information specified for Labeling á7ñ, Labels and Labeling for radioactive component may be distributed or dispensed prior
    Injectable Products: the time and date of calibration; the to completion of the test for Sterility, the latter test being
    amount of Yttrium Y 90 ibritumomab tiuxetan as total MBq started on the date of manufacture.
    (or mCi) and concentration of yttrium 90Y ibritumomab Assay for radioactivity (see Radioactivity á821ñ)—Using a
    tiuxetan, in MBq (or mCi) per mL, at the time of calibration; suitable counting assembly, determine the total radioactivity,
    the expiration date and time; the storage temperature; and in MBq (or µCi), of the unshielded Injection, using a calibrated
    the statement, “Caution—Radioactive Material.” The labeling system.
    indicates that, in making dosage calculations, correction is to
    be made for radioactive decay, and also indicates that the
    radioactive half-life of 90Y is 64.1 hours.

    https://online.uspnf.com/uspnf/document/1_GUID-560A332F-4F03-46CB-A198-B0E8DE7DD778_3_en-US 1/1

    You might also like