This document provides guidelines for qualification of analytical balances and pH meters used in official medicines control laboratories (OMCLs). It discusses the requirements for selection, installation, calibration and ongoing testing of balances and pH meters. Key points include checking that balances are installed in stable, vibration-free locations with controlled temperature and humidity; calibrating balances and pH meters upon installation and on a defined frequency; and conducting tests to verify accuracy, precision, linearity and other performance characteristics. Proper management and calibration of pH electrodes is also covered. The document aims to ensure analytical instruments are qualified and meet performance standards for their intended use in chemical and biological testing.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
The analyst is required to analyze a number of QC samples throughout the run where there are decisions to be made based on a window of acceptance for each QC sample analyzed.
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The objective of any chemical analytical measurement is to get consistent, reliable and accurate data.
Proper functioning and performance of analytical instruments and computer systems plays a major role in achieving this goal.
Therefore, analytical instrument qualification (AIQ) and calibration should be part of any good analytical practice.
Validation of lab instruments and quantitative test methods Mostafa Mahmoud
This lecture shows the procedures applied when going to validate your laboratory instruments and quantitative test methods also either FDA approved or laboratory developed tests.
Anti viral drugs are a class of medication used specifically for treating viral infections.Viruses are obligate intracellular parasites, smallest of all self replicating organisms, able to pass through filter that retain the smallest bacteria.Virus conduct no metabolic process on their own.They invade the host cell which may be bacteria, animal or plant cell.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
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2. • “Validation of an analytical procedure is the
process by which it is established, by laboratory
studies, that the performance characteristics of
the procedure meet the requirements for the
intendedanalyticalapplications.”
• Qualification is part of validation, but the
individual qualification steps alone do not
constituteprocessvalidation
• Qualification deals with components or
elements ofa process
• Validation deals with the entire manufacturing
processofaproduct
3. QUALIFICATIONOFBALANCES
• 8th Annex to the core document “Qualification
of Equipment”, which together should be used
when planning, performing and documenting the
qualification processof balances.
• The core document contains the introduction
and general forms for Level I and II of
qualification, which are common to all types of
instruments.
4. • This guideline describes the
requirements for balances
(electronic - digital) used in
chemical and biological tests
in OMCLs (Official Medicines
Control Laboratory).
• The following types of
balances are considered in
this guideline.
Type Ordinaryname Numberof digits
after
decimalposition
(g)
Accuracy
Class
1. UltraMicroBalances 7 I
2. MicroBalances 6 I
3. Semi-micro Balances 5 I
4. AnalyticalBalances 4 I
5. PrecisionBalances 1to3 II
6. TechnicalBalances 0to1 III
5. ConsiderationsFor
Level I And IIof
Equipment
Qualification
AtLevelI ofthequalificationofbalances(selectionof
instrumentsandsuppliers),itisrecommendedtoselect
a manufacturerofbalancesthatcan satisfytheneedsof
thelaboratoryandworksunder ISO9001 certification.
AtLevelIIofthequalificationofbalances(installation
and releaseforuse),itisrecommendedtocheckall
the requirementssetduringtheselectionofthe
instrument and
Calibrationshouldbeperformedbeforeputtinginto
servicebyanaccreditedexternalservicesupplier,or
internallybyappropriatelyqualifiedpersonnel,using
certifiedreferenceweightsaccordingtoanapproved
procedure
6. RequirementsForBalance
Use
LocationoftheBalance
• The accuracy and precision of weighing results are
closelyassociatedwiththelocationof thebalance.
• OMCLs should ensure that the balance can work
under optimal conditions (weighing room/laboratory,
weighing bench,temperature,light, air,etc.)
• It should be ensured that the weighing bench is
stable, no matter from what material it is made. The
weighing bench should not deform when work is
carried out on it and it must be vibration-proof or the
transfer of vibrations must not influence the weighing
process.
7. Temperature
• As weighing results are influenced by temperature, OMCLs should ensure a
constant temperature is maintained in weighing rooms/laboratories. The
deviation shouldnotexceedmorethan5°Cper hour.
Atmospheric humidity
• The optimum relative humidity (% RH) during a weighing process is between
40 %to60%
• 80 % in cases where the accuracy and linearity of measurements are not
affected.
Light
• Balancesshouldbeprotectedfromdirectsunlight (heat).
Air
• OMCLs should not place balances in the airflow of air conditioners or devices
with ventilatorsnexttodoorwaysorinareasofhigh traffic.
Weighingvessel
• OMCLsmustensure that:
Thesmallest possibleweighingvessels are used.
Ifthematerials thattheweighingvessel ismadeofhaveahigh
degree ofelectricalinsulationthey arenotelectrostatically
charged.
8. Frequency ofQualification
• OMCLs must ensure that qualification/calibration of balances is
done on receipt (i.e. immediately after delivery) or prior to their first
useandafterany repairormove.
• The frequency of qualification/calibration depends on the extent
ofuseofthebalancesandisatthe discretionofindividualOMCLs.
• Qualification/calibrationmustbeperformedin accordancewith a
pre-determinedprotocolin which acceptancecriteriaaredefined
k=correlationcoefficient
SD=standarddeviation
RSD=relativestandarddeviation
9. Parametertobe
checked
Frequency Typicaltolerancelimit
Levelling everydaybefore weighing
begins Acceptancelimitsofthebalance
Internalcalibration
(adjustment) (automaticormanual)
everydaybefore
weighingbegins
Automaticacceptancelimitsof
thebalance
Verification(in
use control)
Atleastoncea week
OMCLsshalldefinetheir
own acceptancecriteria
Accuracy
Frequencytobedefined by
OMCL,typicallyonce a
year
OMCLsshalldefinetheirown
acceptancecriteria
Linearity
Frequencytobedefined by
OMCL,typicallyonce a
year
OMCLsshalldefinetheirown
acceptancecriteria
(k=1±0.0001)
Precision
Frequencytobedefined by
OMCL,typicallyonce a
year
OMCLsshalldefinetheirown
acceptancecriteria
(SD= maximum5*d)
Eccentricity
FrequencytobedefinedbyOMCL,typically
once ayear
OMCLsshalldefinetheirownacceptance
criteria (RSD= 0.05%)
10. • Verification:
Verification of the balance is performed byplacing a suitable weight in the center of
the weighing pan once and comparing the result with pre-defined acceptance
criteria. The same weight should always be used in these verifications. The
acceptancecriteriashallbedefinedbyeachindividual OMCL.
• Accuracy:
The accuracy of the balance is checked by weighing at least three different certified
weights that cover the usual weighing rangeof the balance. It is recommendedthat
the weights have approximately 5%, 50% and 100% of the maximum capacity of
the balance depending on the type of balance.It is recommendedthat the weighing
is repeated atleast5 timesforevery weight,
• Linearity:
The results obtained from a series of accuracy checks can be used to calculate the
correlation coefficient and to check for linearity. The correlation coefficient is
calculated by comparing the nominal and measured masses of the weights. The
acceptance criteria for the correlation coefficient shall be defined by each individual
OMCL.
11. • Precision:
The precision of the balance should be verified by weighing at
least 5timesa weight that isequivalent to approximately50%of
the maximum capacity of the balance. It is recommended to
repeat the test with a weight that is equivalent to approximately
5% of the maximum capacity of the balance, if the balance is
used at the lower range (Proposed criterion: SD = max 5*d,
whered=(actual)scaleinterval(e.g. d=0.1mg)).
• Eccentricity:
The eccentricity test should be carried out using a weight
equivalent to at least 30% of the maximum capacity of the
balance) The weight should be placed between halfway to ¾ of
thedistancefromthe centreofthepantoits edge
12. CALIBRATION/QUALIFICATIONOF
PH- METERS
• This document is the 9th Annex to the core document
“Qualification of Equipment”, which taken together should
be used when planning, performing and documenting the
qualification processofpH meters.
• The core document contains the introduction and general
forms for Level I and II of qualification, which are common
toalltypesof instruments
13. Aim and Scopeof the Guideline
• This guideline describes the requirements for pH meters used for
determination of pH in aqueous solutions. If measurements are
made of test solutions of a non-aqueous or partially non-aqueous
character, suspensions or emulsions, on a system calibrated as
described above, the pH reading can only be considered to be an
approximation of the true value (apparent pH). Appropriate
electrodesshould beusedforsuchtypesof measurement.
14. Considerationsforlevel I and II of
Equipment Qualification
• At level I of the qualification of a pH meter (selection of
instruments and suppliers) it is recommended to select a
manufacturer of pH meters that can satisfy the needs of
the laboratory and works under ISO 9001 certification.
• At level II of the qualification of a pH meter (installation
and release for use) it is recommended to check all
requirements set during the selection of the instrument,
and calibration should be performed before putting into
service by an accredited external service supplier, or
internally by appropriately qualified personnel, using
certified reference buffers according to an approved
procedure
15. ManagementofElectrodes
• Before measurement, the electrode(s) is (are) checked visually. The
electrodes should be appropriately stored according to recommendations of
the manufacturer . Refillable electrodes should be checked to ensure that
the level of the inner electrolyte is satisfactory and no bubbles are present in
the glass bulb. The diaphragm of the reference electrode should also be
checked. Before first use, or if it has been stored out of electrolyte, it is
usually necessary to condition the electrode according to the
recommendationofthemanufacturer.
• If the stabilization of pH is too slow (long response time) or if there are
difficulties in calibration, the electrode will probably need to be cleaned or
replaced. Cleaning procedure depends on the type of sample used as
prescribedin the manual.Regularcleaning is recommended.
16. CalibrationandMeasurement Conditions
• The calibration consists of the determination of the slope and the offset of the measuring system.
Unless otherwise prescribed in the method, all measurements are performed at the same
temperature (± 2.5 °C) usually between 20 and 25 °C. For the temperature correction, when
necessary,followthemanufacturer’sinstructions.
• The apparatus is usually calibrated with two buffer solutions which should be chosen so that the
expectedpHvalueofthetestsample liesin betweenthepHvaluesof thebuffersolutions.The range
shouldbeatleast2pHunits.
• The pH of a third buffer solution of intermediate pH read off on the scale must not differ by more
than 0.05 pH units from the value corresponding to this solution. If the deviation is greater than +/-
0.05 units,this maybe because the range of the bufferschosen was too broad and recalibration with
a different system of buffers may be necessary. Alternatively, a multi-point calibration may be
performedtocovera widerpH-range
17. • In that case it may be necessary to use more than one buffer
solution for the verification depending on the expected pH
valuesofthetestsamples.
• Immerse the electrodes in the solution to be examined and
take the reading in the same conditions as for the buffer
solution.
• Store buffer solutions in suitable chemically resistant, tight
containers, such as type I glass bottles or plastic containers
suitableforaqueous solutions.
Storageof buffer solutions
18. Level IIIand IV Qualificationof pHMeters
• Most commercial pH meters offer a “self test” or “start-up test” where e.g. slope are tested and
comparedtothemanufacturer`s specifications.
Testtobe
performed
Frequency Tolerance Who
Calibration
or verification
of
thermometer
everytwoyears
Manufactures
specification or
OMCL
externalservice
supplieror
OMCL
LevelIII
20. QUALIFICATIONOFUV-VISIBLE
SPECTROPHOTOMETERS
• ThirdAnnex of the coredocument “Qualification of Equipment”,and
it should be used in combination with it when planning, performing
and documenting the UV-Visible spectrophotometer qualification
process The core document contains the Introduction and general
formsforLevelI andII ofqualification,which arecommontoall type
ofinstruments.
• For UV-Visible spectrometers, an example has been added to give
instrument-specificproposalsthatmay beused in combinationwith
the general requirements presented in the core document
“Qualificationof Equipment”,when drawingupaLevel Ichecklist.
21. Level I.Selection ofinstrumentsand suppliers
• This check-list, containing examples of attributes
that can be considered in the selection of an
instrumentand supplier
Level IIof EquipmentQualification:
• Installationandreleaseforuse
Level III.Periodicandmotivatedinstrument checks
22. Examplesofrequirements forUV-Visible spectrophotometers
P a r a m e t e r to be c h e c k e d Typical tolerance limits
1. Spectral slit-width (if applicable)
± 1 0 %
2. Wavelength accuracy
1 n m for the U V range
3 n m for the Visible range
3. Wavelength precision
(for mechanically set wavelengths)
S e e manufacturer’s specifications
4. Photometric accuracy
(Control of absorbance)
S e e A n n e x I
5. Photometric linearity
r2 0 . 9 9 9
6. Limit of stray light
A > 2 . 0 at 1 9 8 n m
7. Baseline noise
± 0 . 0 0 2 A b s o r b a n c e units ( 5 0 0 nm) or
± 0 . 0 1 A b s o r b a n c e units (200, 3 0 0 , 4 0 0 nm)
8. Photometric drift
± 0 . 0 0 1 A b s o r b a n c e units/h ( 2 5 0 nm) or
± 0 . 0 0 2 A b s o r b a n c e units/h ( 5 0 0 nm)
23. LevelIV.In-useinstrumentchecks
• Examples ofrequirements forUV-Visible spectrophotometers
Parameters Tolerance
1. System suitability check of the method
• E.g. Repeatability
• Resolution
According to MAH dossier or Validated in
house method
2. Absorption Cells Absorbance Difference 0.005
24. Level III. Periodic and
motivated instrument
checks
This Annex contains practical
examples of tests and their
associated tolerance limits for
several parameters related to
the performance of a UV-
Visiblespectrophotometer
GENERAL CONSIDERATIONS
• Measurements made by comparing samples against
external standards should be made under conditions
during which temperature is held constant. This is
particularly relevant where the carrier solvent is
organic, and measurements may be distorted by
expansionorevaporationofthe solvent.
• It is recommended to perform the qualification within
the spectral range corresponding to the region of
analytical interest.
• Ensure that the spectrophotometer has stabilized,
according to the manufacturer’s recommendations,
beforestartingthe qualificationtests.
25. 1. SPECTRALSLIT WIDTH(ifapplicable)
• When using an instrument on which the slit- width is variable at the selected
wavelength, the slit-width must be small compared with the half- width of
the absorption band, but it must be as large as possible to obtain a high value
of I0. Therefore, a slit-width is chosen such that further reduction does not
result ina changein absorbancereading.
MethodandLimits:
• Switch the systemonand startthe Scanmodule.
26. • Start a scan and examine the trace for a spectral
peak around 656.1 nm. If no peak is seen or it is
less than50%T,increasethe gain.
• Ifthesignalexceeds100%T,reducethe gain.
• Measure the width of the peak (in nanometres)
athalftheheightofthe peak.
• This represents the spectral bandwidth and
should be within ± 10% of that selected via the
computer.
28. 2.WAVELENGTH ACCURACY
• If the determination is performed by using the specific absorbance , the frequency of this
checkshouldbe higher.
Materials:
• Verifythewavelengthaccuracyusingtheabsorption maximaof holmiumperchloratesolution
Rprepared
• Ifavailable,thebuilt-inmercurylampoftheinstrumentmaybeused forthistest.
• Alternatively, use suitable filters typically made incorporating rare earth metal oxides. Ideally
thecalibrantshoulddemonstrate traceabilitytonational orinternationalstandardsandshould
carrya statementabouttheassociated uncertainty.
30. 3.WAVELENGTH PRECISION
Materials:
• For this test, the same materials of the previous test can be used: Holmium perchlorate solution
R prepared
• If available, the built-in mercury lamp of the instrument may be used for this test. Alternatively,
suitablecommercialcertifiedfiltersmaybe used
Method:Carryout6 measurementsoftheabsorbancemaxima.
Limits:
• Repeatability: the relative standard deviation of the absorbance maxima should satisfy the
manufacturer’sspecifications.
• The difference between the 6 individual peaks should comply with the manufacturer’s
specifications(e.g. <0.5nm).
• Where old instruments are involved, the wavelength may be set by turning a wheel until the
selected wavelength is reached. Where this is the case, mechanical wear may result in a
different wavelength being selected depending on whether starting above or below the target
wavelength. Examinethevariationby settinga wavelengthfromaboveandbelowand seeing if
thereisa difference.
31. 4. PHOTOMETRIC ACCURACY (CONTROL OF
ABSORBANCE)
• Note: if the determination is performed by using the
specific absorbance the frequency of this check should be
higher.
• Materials:
• Solution of potassium dichromate R, previously dried to
constantmassat130 °C.Forthecontrolofabsorbanceat 235
nm, 257 nm, 313 nm and 350 nm, dissolve 57.0-63.0 mg of
potassium dichromate R in 0.005 M sulphuric acid and
dilute to 1000.0 ml with the same acid. For the control of
absorbance at 430 nm, dissolve 57.0-63.0 mg of potassium
dichromate R in 0.005 M sulphuric acid and dilute to 100.0
mlwiththesame acid.
• Alternatively, suitable commercial certified filters may be
used
32. Method:
• Check the absorbance using the solution of potassium dichromate R or the certified filters at
the wavelengths indicated in the table below, which gives for each wavelength the exact
valuesandthepermittedlimits ofthespecific absorbance.
Wavelength SpecificAbsorbance Max.Tolerance
235 124.5 122.9to126.2
257 144.5 142.8to146.2
313 48.6 47.0to50.3
350 107.3 105.6to109.0
430 15.9 15.7to16.1
33. Photometric
Linearity
Materials:
• A series of solutions of a suitable absorbing compound (e.g.
potassium dichromate) spanning the concentration range of
interest. The absorbing solutions need to be stable. The
concentrations should be regularly spaced (1, 2, 3, 4, 5) rather
than doubling (1, 2, 4, 8, 16) in order to reduce the leverage
effectswhenfittingthe line.
Method:
• Measure the net absorbance of the solutions against a blank
at 235,
• 313,257and350nm.
• Make 3 measurements for each solution. Calculate the
meanvalue andthelinearityofthe
• concentration of each solution against the measured
absorbanceat thecontrol wavelengths.
• Limits:Ateachwavelength:r2≥ 0.999
35. REFERENCES
1. Guidance on Equipment Qualification of Analytical Instruments: UV-
VisibleSpectro(photo)meters (UV-Vis). Valid Analytical Measurement (VAM)
Programme
2. OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT ,
EDQM
3. B. Gouthami, Gattu Venkateshwarlu, Calibration and Validation of HPLC, GC and UV-
VIS Spectroscopy, International Journal of Modern Chemistry and Applied Science
2014,1(4),27–34
