SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
Prepared By
Concerned Dept
1.
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/QC/022
Page No.
:
1 of 4
Supersedes
:
New
Revision No.
:
00
Effective Date
Review Date
Objective
To define the procedure for Operating and Calibration of UV and Visible
Spectrophotometer.
2.
Scope
This procedure is applicable to Quality Control department at Solitaire Pharmacia Pvt. Ltd.,
Baddi.
3.
Responsibility
Executive Quality Control
4.
Accountability
Head Quality Control
5.
Procedure
5.1.
Instrument Detail:
Name
UV- SPECTROPHOTOMETER
Make
SHIMADZU
Model
UV-1800
Sr.No.
A11454703180
Instrument ID.
QCD/UVS/002
Location
Instrument Lab.
5.2.
Operation Procedure:
5.2.1.
Ensure that instrument is clean and free from dust.
5.2.2.
Switch “ON” the main supply by pressing “ON/OFF” switch.
5.2.3.
Now switch on the instrument by pressing “ON/OFF” switch just back of the
instrument.
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
5.2.4.
It takes some time form initialization.
5.2.5.
After initialization main window will display.
5.2.6.
Before start analysis by UV check date and time.
SOP. No.
:
SPL/ SOP/QC/022
Page No.
:
2 of 4
Supersedes
:
New
Revision No.
:
00
Effective Date
Review Date
5.3.
For Traspetancy (%T):
5.3.1.
Click single wavelength > Click %T.
5.3.2.
For Single Wavelength:
5.3.3.
Click Photometer > Single wavelength.
5.3.4.
Enter the required wavelength.
5.3.5.
Click OK.
5.4
For Wavelength Scan:
5.4.1.
Click Transpetance > wavelength Scan on main menu.
5.4.2.
Enter the required range of wavelength.
5.4.3.
Click OK.
5.5.
Calibration Procedure:
5.5.1.
Control of wavelength:
Sample Preparation: Prepare a 4% w/v of Holium Oxide in 1.4M Perchloric Acid.
Sr.
No.
01
02
03
04
5.5.2.
Wavelength
241.15 nm
287.50 nm
361.50 nm
536.30 nm
Observed Wavelength
Acceptance Criteria
240.15 to 242.15 nm
286.15 to 288.15 nm
360.15 to 362.50 nm
533.30 to 539.30 nm
Control of Absorbance:
Sample Preparation: 57.0 to 63.0mg of Potassium diChromate→1000 ml with 0.005M
Sulphuric Acid
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
Sr. Wavelength
No.
01
02
03
04
Observed
Absorbance
SOP. No.
:
SPL/ SOP/QC/022
Page No.
:
3 of 4
Supersedes
:
New
Revision No.
:
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QA-Head
Effective Date
Calculate
Absorbance
(1%,1cm)
Standard
Absorbance
(1%,1cm)
124.50
144.00
48.00
106.60
235 nm
257 nm
313 nm
350 nm
Calculation: Absorbance (1%, 1cm)
Review Date
Maximum
Tolerance
Limit
122.90 to 126.22
142.40 to 145.70
47.0 to 50.30
104.90 to 108.20
Absorbance x 100 x 100
Wt of Potassium dichromate
Sample Preparation: 57.0 to 63.0 mg of Potassium dichromate →100 ml with 0.005M
Sulphuric Acid
Sr. Wavelength
No.
01
Observed
Absorbance
=
Calculate
Absorbance
(1%,1cm)
430 nm
Calculation: Absorbance (1%, 1cm)
=
Standard
Absorbance
(1%,1cm)
Maximum
Tolerance
Limit
15.90
15.70 to 16.10
Absorbance x 100 x 10
Wt of Potassium dichromate
Limit of Stray Light:
Sample Preparation: Dissolved 1.2 gm of Potassium Chloride in 100 ml with water
Absorbance at 200 nm
=………..
Limit =
Greater than 2.0
Resolution Power:
Sample Preparation: Dissolved 2.0 ml of Toluene with Hexane in 100 ml of volumetric
flask→ further take 1.0 ml →100 ml with Hexane in 100 ml volumetric flask..
i. Maximum at 269 nm
Absorbance =
…..
ii Minimum at 266 nm
Absorbance =
…..
Ratio of Absorbance =
……………..
(Limit: NLT 1.5)
If instrument is working under satisfactory condition then affix Calibration Label.
If it is not working under satisfactory condition then inform maintenance department.
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
Prepared By
Concerned Dept
6.
7.
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/QC/022
Page No.
:
4 of 4
Supersedes
:
New
Revision No.
:
00
Effective Date
Records/Formats:
SPL/QC/032
-
Log book for UV and Visible Spectrophotometer
SPL/QC/033
-
Calibration of UV and Visible Spectrophotometer
Annexure:
NA
8.
Reference:
Nil
9.
10.
Abbreviations:
SPL
-
Solitaire Pharmacia Pvt. Ltd., Baddi
QC
-
Quality Control
SOP
-
Standard Operating Procedure
Revision History:
Revision No
00
Format No.SPL/QA/001
Effective date
Reason for Revision
New Document
Review Date
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
:
SPL/ SOP/QC/022
Approved By
QA-Head
Log book for UV and Visible Spectrophotometer
Format No : SPL/QC/032
Operation Time
Sr. No.
Date
Format No.SPL/QA/001
Product Name
Batch No.
On
Time
Off
Time
Operated
By
Check
By
Remarks
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
:
SPL/ SOP/QC/022
Approved By
QA-Head
Calibration of UV and Visible Spectrophotometer
Format No : SPL/QC/033
Date of Calibration:
Next Due Date:
Name of Instrument
:
UV and Visible Spectrophotometer
Make
:
Shimadzu
Model No.
:
UV-1800
User Department
:
Quality Control
Instrument Code
:
QCD/UVS/002
Calibration Schedule
:
Monthly
Control of Wavelength:
Sample Preparation: Prepare a 4% w/v of Holium Oxide in 1.4M Perchloric Acid
Sr. No.
Wavelength
01
241.15 nm
02
287.50 nm
03
361.50 nm
04
536.30 nm
Control of Absorbance:
Observed Wavelength
Acceptance Criteria
240.15 to 242.15 nm
286.15 to 288.15 nm
360.15 to 362.50 nm
533.30 to 539.30 nm
Sample Preparation: ……….. mg of Potassium diChromate→1000 ml with 0.005M Sulphuric Acid
Sr. No.
Wavelength
01
02
03
04
235 nm
257 nm
313 nm
350 nm
Observed
Absorbance
Calculation: Absorbance (1%,1cm)
=
Calculate
Absorbance
(1%,1cm)
Standard
Absorbance
(1%,1cm)
124.50
144.00
48.00
106.60
Maximum
Tolerance
Limit
122.90 to 126.22
142.40 to 145.70
47.0 to 50.30
104.90 to 108.20
Absorbance x 100 x 100
Wt of Potassium dichromate
Sample Preparation: ……… mg of Potassium dichromate →100 ml with 0.005M Sulphuric Acid
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Operation & Calibration of UV & Visible Spectrophotometer
SOP. No.
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
Calculation: Absorbance (1%,1cm)
:
SPL/ SOP/QC/022
Approved By
QA-Head
=
Absorbance x 100 x 10
Wt of Potassium dichromate
Limit of Stray Light:
Sample Preparation: Dissolved …………. gm of Potassium Chloride in 100 ml with water.
Absorbance at 200 nm
=
………..
Limit =
Greater than 2.0
Resolution Power:
Sample Preparation: Dissolved 2.0 ml of Toluene with Hexane in 100 ml of volumetric
flask→further take 1.0 ml →100 ml with Hexane in 100 ml volumetric flask..
i. Maximum at 269 nm
Absorbance
=
…..
ii Minimum at 266 nm
Absorbance
=
…..
Ratio of Absorbance
=
……………..
(Limit: NLT 1.5)
Remark: The instrument is working/ not working under satisfactory condition.
Analyzed By:
Checked By:
Approved By:
Date
Date
Date
:
Format No.SPL/QA/001
:
: