Batch Record Sample

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  • 7/28/2019 Batch Record Sample

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    Page 1 of 3

    M.I. NO.

    62150

    COMPOUNDING INSTRUCTIONS:

    6 Molar Hydrochloric Acid (HCl)

    STD. YIELD

    LOT NO.

    XXXX -

    EFFECTIVE DATE

    DRAFT

    SUPERSEDES

    NEW

    ACTUAL YIELD

    *** APPROVALS ***

    Development Manufacturing Operations Quality Assurance

    By JoeBeaker Mary ErhlenmeyerMary ErhlenmeyerMary ErhlenmeyerMary Erhlenmeyer Nick Translation Megan Codon

    Date 5/6/99 7/2/99 7/1/99 6/3/99

    C O N F I D E N T I A L

    QA Issued By Date

    HAZARD COMMUNICATION:

    Hydrochlori c Acid, 6M

    DANGER: CORROSIVE. AVOID CONTACT WITH SKIN AND EYES. AVOID INHALATIONOF VAPOR AND MIST. DO NOT MIX WITH CAUSTICS OR OTHER REACTIVES.

    Water For Injection

    WARNING: HOT. WFI IS MAINTAINED AT A TEMPERATURE OF 80-95C. TAKENECESSARY PRECAUTIONS TO AVOID SKIN CONTACT AS BURNING MAYOCCUR. WEAR PROTECTIVE GLOVES WHILE PERFORMING PREVENTIVEMAINTENANCE ON THE STILL, TANKS AND PIPING OR HANDLING THEWATER IN PRODUCTION.

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    Page 2 of 3

    M.I. NO.

    62150

    COMPOUNDING INSTRUCTIONS:

    6 Molar Hydrochloric Acid (HCl)

    LOT NO.

    XXXX -

    EFFECTIVE DATE

    DRAFT

    SUPERSEDES

    NEW

    C O N F I D E N T I A L

    PROCEDURE

    1. Into a clean, calibrated container, collect approximately 100 L of water for injection (WFI) and cover the

    container. Let cool to ambient temperature.

    Vessel ID Wagner 6253

    Amt WFI Collected 102 L

    Collected By J DS

    Date/Time 7/25/00 /1:30 AM/PM

    Temperature at Collection

    Verified By PDS

    2. Slowly add 200 L (236kg) of 36-38% [~12 M] HCl into the vessel containing the WFI and stir slowly.

    Temperature of WFI 82 F Ambient Temperature 70 F

    Rec #HCl Good Chem 55624 HCl Added By J DS

    Balance ID Bettler 20000K Date/Time 7/25/00 /2:32 AM/PM

    Amt Weighed 236 kg Addition Verified By PDS

    Weighed By J DS Volume 298 L

    Date/Time 7/25/00 /1:47 AM/PM

    Weight/Volume Verified By PDS

    NOTE: Collected water must be used.

    3. QS with WFI to 400 L. Add WFI slowly.

    * Amt WFI Added 158 L

    Added By J DS

    Date/Time 7/25/00 /3:55 AM/PMFinal Vol in Container 400 L

    Verified By

    (* Final Volume - Volume at end ofStep 2.)

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    Page 3 of 3

    M.I. NO.

    62150

    COMPOUNDING INSTRUCTIONS:

    6 Molar Hydrochloric Acid (HCl)

    LOT NO.

    XXXX -

    EFFECTIVE DATE

    DRAFT

    SUPERSEDES

    NEW

    C O N F I D E N T I A L

    4. Complete vessel identification tag as follows and attach to tank.

    QA Reviewed By Peter D. Sodium

    HCl 6M

    ID# _72500A___

    Date Compounded:

    7/25/00

    Compounded By:

    James B. Dalton

    EXPIRY:

    30 days from compounding