Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 46 views

    Certificate of Analysis: Print Date

    Uploaded by

    Christian SF
    This certificate of analysis summarizes the test results for a batch of Pyrogent-5000 Bulk Kit. The batch passed all specifications tests, including sterility, endotoxin activity, and coefficient of variation. The bulk kit contains 100 vials with a material number of T50-600U and expiration date of March 4, 2024. It was manufactured on May 24, 2022.

    Copyright:

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

    Certificate of Analysis: Print Date

    Uploaded by

    Christian SF
    46 views2 pages
    This certificate of analysis summarizes the test results for a batch of Pyrogent-5000 Bulk Kit. The batch passed all specifications tests, including sterility, endotoxin activity, and coefficient of variation. The bulk kit contains 100 vials with a material number of T50-600U and expiration date of March 4, 2024. It was manufactured on May 24, 2022.

    Original Title

    T50-600U-0001124156

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This certificate of analysis summarizes the test results for a batch of Pyrogent-5000 Bulk Kit. The batch passed all specifications tests, including sterility, endotoxin activity, and coefficient of variation. The bulk kit contains 100 vials with a material number of T50-600U and expiration date of March 4, 2024. It was manufactured on May 24, 2022.

    Copyright:

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

    Certificate of Analysis: Print Date

    Uploaded by

    Christian SF
    This certificate of analysis summarizes the test results for a batch of Pyrogent-5000 Bulk Kit. The batch passed all specifications tests, including sterility, endotoxin activity, and coefficient of variation. The bulk kit contains 100 vials with a material number of T50-600U and expiration date of March 4, 2024. It was manufactured on May 24, 2022.

    Copyright:

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

    Page 1 of 2

    Certificate of Analysis

    eShop Dummy Customer MX Print Date: 19-Dec-2022


    used in eShop only
    MEXICO

    ____________________________________________________________________________

    Product Name: Pyrogent-5000 Bulk Kit


    100 Vials/Kit
    Material Number: T50-600U
    Batch No: 0001124156
    Manufacturing Date: 24-May-2022
    Expiration Date: 04-Mar-2024

    ____________________________________________________________________________

    SPECIFICATION
    Test RESULT MIN MAX UNIT
    ____________________________________________________________________________
    T50-600 Matched to 7460
    Lysate Product Number: T50-600
    Lysate Lot Number YL024D01T6
    Lysate Sterility:
    Bulk Negative NEGATIVE ***
    Final Container Negative NEGATIVE ***
    CSE Product Number: 7460
    CSE Lot Number 0001097402
    Bacterial Strain: E. coli O55:B5
    RSE/CSE Ratio (EU/ng) 6 *** ***
    CSE Reconstituted is 100 EU/ml
    1 EU/ml = 1 IU/ml
    CSE Reconstitution Volume (ml) 6.5 2.0 10.0
    Final Release Test:
    Linearity Pass *** r <=-0.980
    Enzyme Activity (Reaction Time)
    Blank - 0.01 EU/ml (seconds) Pass >= 300 ***
    0.01 EU/ml (seconds) Pass *** <= 5100
    1.0 EU/ml (seconds) Pass *** <= 1500

    This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
    Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
    and thus handwritten signatures are not required. 8830 Biggs Ford Road
    Walkersville, MD 21793 8415
    For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
    Fax (301) 845 4024
    Page 2 of 2

    Certificate of Analysis

    eShop Dummy Customer MX Print Date: 19-Dec-2022


    used in eShop only
    MEXICO

    ____________________________________________________________________________

    Product Name: Pyrogent-5000 Bulk Kit


    100 Vials/Kit
    Material Number: T50-600U
    Batch No: 0001124156
    Manufacturing Date: 24-May-2022
    Expiration Date: 04-Mar-2024

    ____________________________________________________________________________

    SPECIFICATION
    Test RESULT MIN MAX UNIT
    ____________________________________________________________________________
    Coefficient of Variation (%) Pass *** <= 10

    Additional Information:
    The FDA has stated that the use of a Certificate of Analysis exempts a firm from having to perform the RSE/CSE
    comparison in their own laboratories. However, firms should understand exactly how the LAL manufacturer
    performs the test. The procedure detailed below represents the test method currently used at Lonza. Duplicate
    samples from independent endotoxin dilution series are prepared from four (4) separate vials of test CSE. These
    samples are tested against an endotoxin standard curve prepared from the RSE with the specified lot of LAL reagent.
    The predicted potency, adjusted for dilution, for each CSE dilution falling within the limits of the RSE standard
    curve is determined. The overall average potency of all such CSE dilutions is used to determine the reconstitution
    volume to yield an endotoxin solution containing 100 EU/ml.

    Susan Thomas
    Electronically signed by Susan Thomas
    Date: 26-MAY-2022 07:57:26 EST
    Release ( Inspection Lot: Usage Decision )

    This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
    Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
    and thus handwritten signatures are not required. 8830 Biggs Ford Road
    Walkersville, MD 21793 8415
    For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
    Fax (301) 845 4024

    You might also like