‫ م‬4:41 2023/‫‏‬7/‫‏‬11 SOP for Shimadzu LabSolutions

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USP 2021 (United State Pharmacopeia

Home  Quality Control  SOP for Shimadzu LabSolutions
44 - NF 39)
 January 09, 2022

SOP for Shimadzu LabSolutions

USP 2023 (USP 46 –NF 41)
 Anonymous  June 17, 2022
 May 23, 2023

OBJECTIVE
To promote the effective use of the Shimadzu LabSolutions Software for HPLC to Types of Tooling in Compression
establish an instrumental method and analyze the chromatogram obtained. Machine
 May 28, 2020

SCOPE
This is applicable to the operation of Shimadzu LabSolutions Software for HPLC. SOP for Preparation of Master
Formula Record (MFR)
RESPONSIBILITY  January 13, 2022

It is the responsibility of the QC Executive.

Tablet Scoring Study of Azithromycin
ACCOUNTABILITY Tablets USP 500mg (Tablet Breakline
Manager – Quality Control Study)
Manager – Quality  January 04, 2022

SOP for Entry, Exit and Gowning

PROCEDURE
procedure for Powder Processing
Area
Turning on the instrument:
 May 25, 2023

• Turn on UPS
• Power on the controller/Pump A. Power on the modules other than the system  ACCOUNTS 11 POSTS
controller in any sequence
• Turn on the computer and Printer
 AHU 5 POSTS

 AUDIT 16 POSTS
Purging the mobile phase:
Put the mobile phase in the reservoir tray and then:  BUSINESS 25 POSTS

1. Open the drain valve of the pump module  CALIBRATION 1 POSTS

2. Push the purge button

 CLEANING 3 POSTS
3. Purging will start and it will automatically stop after 3 minutes. To stop purging
before 3 minutes press the purge button again and close the drain valve. If  COSTING 4 POSTS
purging stops automatically only close the drain valve.
 EXPORT 1 POSTS

 FACEMASK 10 POSTS

 GPAT 1 POSTS

 HUMAN RESOURCES 6 POSTS

 INTERVIEW 9 POSTS

 STERILE 4 POSTS

 VALIDATION 34 POSTS

• Double-click the (LabSolutions) icon on the Desktop.

USP 2021 (United State Pharmacopeia 44 - NF 39)
 January 09, 2022

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‫ م‬4:41 2023/‫‏‬7/‫‏‬11 SOP for Shimadzu LabSolutions
•Select [Admin] in the [User ID] list for the first login to the system, and click [OK].
The [LabSolutions Main] window opens.

• Click the icon. USP 2023 (USP 46 –NF 41)

 May 23, 2023
• Select and double-click the instrument that will be used for data acquisition. The
[Realtime Analysis] program opens. A beep sound will be heard if the software is
successfully connected to the instrument. Types of Tooling in Compression
Machine
 May 28, 2020
Note: If the Data Acquisition) icon is not displayed, click on
the title of the assistant bar.
SOP for Preparation of Master
• Ensure that [Ready] is displayed on the status display in the [Data Acquisition] Formula Record (MFR)
window.  January 13, 2022

SOP for Analytical Data Review

PEOPLE ALSO READ: SOP for Calibration of Shimadzu HPLC (Prominence – i LC – 2030)
 May 19, 2023

Set the Instrument Parameters:

• Click [Advanced] to open the [Advanced] sub-window. Tablet Scoring Study of Azithromycin
• Click [Data Acquisition] and set end time Tablets USP 500mg (Tablet Breakline
Study)
•Click [Pump]: Select mode: Binary gradient, set Total flow: 2mL/min, Set B Conc:  January 04, 2022
50%, Set Maximum Pressure for Pump A & B: 250 kgf/cm2
• Click [Detector] Accounts AHU Analytical Method Audit

Books Business Calibration Cleaning

Set Wavelength CH 1: 325 nm
Cosmetics Costing COVID-19
• Click [Column Oven] and Set Oven Temperature: 40℃ [Ambient +15℃ or 40℃]
Dexamethasone Engineering Export
• Click [Save Method File As] on the [File] menu.
Facemask GPAT HPLC Human Resources
• Enter the file name and click [Save].
Insurance Interview Maintenance
• Click .
Marketing Microbiology Packing

• Click the (Instrument On/Off) button on the toolbar. Pharma Education Pharmacopeia

Product Development Production Qualification

Single Run
Quality Assurance Quality Control sterile

• Click the (Start Single Run) icon on the [Acquisition] assistant bar. Trading Validation Video Warehouse

• Set the acquisition conditions, and click [OK]. ZyCoV-D

1. Enter the data file name.

Jun 2022 (34)
2. Select [Auto-increment] and the number type. The data file name is
automatically appended with an incremental number.
3. Enter the position of the sample for [Vial#] and [Tray]:1

4. Enter the sample injection volume: 10µL

5. A single run is started. Data acquisition ends when the data acquisition time in
the method file has elapsed.

Change the End Time during Data Acquisition

• Click [Change Acquisition Time] on the [Acquisition] menu.
• Enter an [Acquisition Time], and click [OK].

Stop Single Run

• Click the (Stop) icon on the [Acquisition] assistant bar. Data acquisition
is stopped, and a data file is created for the data so far.

Realtime Batch

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‫ م‬4:41 2023/‫‏‬7/‫‏‬11 SOP for Shimadzu LabSolutions

•Click the (Realtime Batch) icon on the [Main] assistant bar in the
[Realtime Analysis]
• Program to display the Batch Table.

PEOPLE ALSO READ: SOP for Operation of Shimadzu HPLC (Prominence – i LC– 2030)

• Enter the sample information, vial #, Tray#, Sample Name, Sample ID, method
file name, data file name and Injection Volume in a Batch Table to sequentially
acquire data from multiple samples.

1. Click [New] at [Batch Table] to create a new Batch Table file.

2. Right Click and then click [Add row] to add rows to the currently displayed
Batch Table.
3. Enter the sample information, vial #, Tray#, Sample Name, Sample ID, Sample
type, method file name, and data file name and Injection Volume in a Batch Table
to sequentially acquire data from multiple samples.
4. Save the Batch Table

Data Acquisition Using Batch Tables

• Select the row numbers to be analyzed.

•Click the (Start Realtime Batch) icon on the [Realtime Batch] assistant
bar.
• Check [Selected Row(s)], and click [Start].
• In this screen, click [OK]. Batch processing of the selected rows is executed.

Stop Realtime Batch

• Click the (Stop) icon on the [Realtime Batch] assistant bar.

• Select the processes to stop, and click [OK]. Batch processing is stopped.

Pause Realtime Batch to Edit the Batch Table

•During realtime batch, click the (Edit Table/Restart) icon on the [Realtime
Batch] assistant bar.
• Set the row where realtime batch is to be paused, and click [OK]. Data
acquisition goes into the standby state at the selected row, and batch processing
is paused.
•Select the row to be deleted on the Batch Table, right-click on the selected row,
and click [Delete Row].

• Click the (Save) button on the toolbar.

•Click the (Edit Table/Restart) icon on the [Realtime Batch] assistant bar.
Batch processing is resumed from the paused row.

Shutdown Analytical Instruments After Data Acquisition

• Click the (Settings) icon on the [Realtime Batch] assistant bar.

•Click the [Shutdown] tab, enter the conditions for automatic shutdown of the
analytical instruments, and click [OK].

1. Select [Shutdown].

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2. Select [Shutdown Method File], and enter the name of the method file that
contains the parameters for shutdown of the analytical instruments.

• Click the (Save) button on the toolbar.

Calculation:

• Click the icon in the [LabSolutions] Main window.

• Double-click [Postrun].

• Click the (Data Analysis) icon assistant bar to open the [Data Analysis]
window.
• By Data Explorer, find out the Data file(Where it was Saved)
• Open a Standard Data By Double click on it,
• Click Wizard, A window Will appear
• Set Width: = 5, Slope=200, Mim Area/ Height= 100000 or other.
• Click Next
• Select Box by its Retention time
• Click Next
• Set Quantitative Method = External Standard, # of calibration level[If you use one
standard concentration give 1(one-point calibration), If you use two different
standard concentrations give 2 (two-point calibration), If you use three different
standard concentrations give 3(3 point calibration)], unit: ppm
• Click Next
• Click Next
• Type Name: Retinol and set conc. of Std
• Click FINISH
• Click APPLY TO METHOD. Click Yes. Click Yes. Save Method As window appears.
Give a method file name and click Save.
• Click Yes or OK all the time if other things appear.
• Click Postrun Batch on the Assistant Bar
• Click File>New Batch File to create a batch file for calculation.
• Click Data Tab on the Data Explorer. Select one standard data file and drag it to
the first row.
• Right-click mouse keeping the mouse on the batch Table. Click ADD ROW to add
another row in the table.
• Click Data Tab on the Data Explorer
• Drag the unknown data file to the last row created
• Right Click on batch table
• Click Table Style
• Select Dilution Factor from the left panel and click the Right directed arrow.
• Enter the values of the item in the batch table as shown below.
• Click file. Then Save Batch File As and Give a file name. Then Click Save
•Click Start Postrun Batch. The batch Calculation process will start. If any other
windows appear after clicking Start, click OK or Yes.

Dilution Factor, D.F (or Multiplication Factor):

For Single Components,

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Where
W= Average Weight of Sample (Unknown)
V2 = Second dilution of Standard
V2’ = Second dilution of Sample
V4 = Injection volume
P= Potency =93.5% i.e. 93.5/100 etc.

Reports:
REPORT (External Standard):
• Click Report Format on Assistant Bar
• Click File. Then click Open Report Format File and open report format.
• Drag & drop one of the Data file on the Sample Information Table
•Drag & drop the several Data file on the Summery Compound Table for
Standard.
• Drag & drop the several Data file on the Summery Compound Table for Sample.

Print Report:
Click the Print Icon and then OK to complete printing.

ABBREVIATION
SOP: Standard Operating Procedure

ANNEXURE
Nil

REVISION HISTORY
Nil

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