Scribd Logo
Upload

Welcome to Scribd!

  • 37 views

    Reference Material Certificate I S O 1 7 0 3 4

    Uploaded by

    alexis
    Analytical techniques like HPLC were used to characterize the reference material. The certificate provides traceability, production, and quality assurance details in accordance with ISO 17034 and ISO 17025 standards.

    Copyright:

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

    Reference Material Certificate I S O 1 7 0 3 4

    Uploaded by

    alexis
    37 views2 pages
    Analytical techniques like HPLC were used to characterize the reference material. The certificate provides traceability, production, and quality assurance details in accordance with ISO 17034 and ISO 17025 standards.

    Original Title

    Untitled

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Analytical techniques like HPLC were used to characterize the reference material. The certificate provides traceability, production, and quality assurance details in accordance with ISO 17034 and ISO 17025 standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    37 views2 pages

    Reference Material Certificate I S O 1 7 0 3 4

    Uploaded by

    alexis
    Analytical techniques like HPLC were used to characterize the reference material. The certificate provides traceability, production, and quality assurance details in accordance with ISO 17034 and ISO 17025 standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    REFERENCE MATERIAL CERTIFICATE ISO 17034

    Reference Material
    This certificate is designed in accordance with ISO 17034 and ISO Guide 31. This reference material (RM) was designed,
    produced and verified in accordance with ISO/IEC 17025, ISO 17034 and a registered quality management system ISO
    9001.

    Product Name
    Famoxadone

    Product Code Lot Number


    DRE-C13399000 G1123479
    CAS No. Format
    131807-57-3 Neat
    Mol. Weight Expiry Date
    374.39 22 Jan 2025
    Mol. Formula Storage Temp
    C22H18N2O4 20°C ± 4°C

    CERTIFIED CERTIFIED
    Purity Expanded Uncertainty (U)
    98.37% (g/g) 0.30% (g/g)

    Uncertainty
    The certified value(s) and uncertainty(ies) are determined in accordance with ISO 17034 with an 95% confidence level (k=2).
    Uncertainty is based on the Total Combined Uncertainty, including uncertainties of characterisation, homogeneity and
    stability testing. Stability values are based on real evidence opposed to simulation.

    The producer certifies that this reference material meets the specification stated in this certificate until the expiry date,
    provided it is stored unopened at the recommended temperature herein. Product warranties for this reference material are
    set out in the terms and conditions of purchase.

    CERTIFIED BY CERTIFIED ON
    RM Release
    N. Müller 22 Jan 2021

    Version 1 Page 1 of 2
    REFERENCE MATERIAL CERTIFICATE ISO 17034

    Instrument
    CHROMATOGRAM

    HPLC/DAD

    Detection
    DAD

    Column
    ReproSil 100 C18 5 µm 250 x 3 mm

    Method Details
    Acetonitrile:Water
    4:1

    Inj.-Vol.
    5.0 µL

    Flow
    1 mL/min

    Method of Characterisation
    Purity = 100% – Assay impurities – Water content (KF) – Residual Solvents (NMR)

    Method of Identification
    EA, NMR, RT, IR, MS, UV

    Batch Information
    Water Content: <0.10% (g/g) by Karl-Fischer-Titration (U(exp) = 0.08% (g/g)).

    Intended Use the balances is verified daily internally Instructions for use
    This RM is intended for use in a and annually by an external accredited It is recommended to use 1 mg as the
    laboratory as a calibration and quality calibration service. Chromatographic minimum sample size and if less
    control standard or in method methods are traceable to the material is used, to increase the
    development for analytical International System of Units (SI). certified uncertainty by a factor of two
    techniques. for half sample and four for a quarter
    Homogeneity of sample. If storage after opening is
    Safety Random replicate samples of the final necessary, the RM should be tightly
    Proper precautions should be packaged RM have been analysed to closed and kept from light and
    observed while handling. See Safety prove homogeneity compliant with moisture. If the RM was in a sealed
    Data Sheet. ISO 17034. ampoule, it should be transferred to a
    vial with minimum head space. Visit
    Traceability Storage the support section of our website
    The balances used for gravimetric The RM should be stored in the lgcstandards.com for a series of
    measurements are calibrated with original sealed container at the Dr. Ehrenstorfer Tech Tip videos and
    weights traceable to the national indicated temperature. frequently asked questions.
    standards (DKD). The calibration of

    LGC Labor GmbH


    Bgm.-Schlosser-Straße 6A LGC Labor GmbH is accreditated by
    86199 Augsburg, Germany DAkkS accreditation numbers
    T | +49 821 906080 D-RM-19883-01-00 & D-PL-19883-01-00
    F | +49 821 9060888 on ISO 17034:2017 & ISO/IEC 17025:2018
    E | [email protected]

    Version 1 Page 2 of 2

    You might also like