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7/28/2019 Batch Record Sample
1/3
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.
7/28/2019 Batch Record Sample
2/3
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.)
7/28/2019 Batch Record Sample
3/3
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