QUALIFICATION OF UV-

VISIBLE
SPECTROPHOTOMETER
By
Student Name-Gitanjali Sahu
Roll No-21ph204a03
Branch- Pharamaceutical Analysis
Under the guidance of
Dr G.Kiran
CONTENT
1. Qualification
2. Instrumentation of UV Visible
spectrophotometer 
3. Level II installation procedure 
4. Level III Performance qualification
parameters
5. Level IV in use instrument checks
QUALIFICATION-
It is an act or process to assure something complies with some
conditions, standards or specific conditions.
 Types
 Design Qualification- document which shows that plant
design agrees with the design specifications of the customer.
 Installation Qualification-documented evidence is given that
all parts of equipment are installed according to the
equipment supplier's  and purchase specifications.
 Operational Qualification-documented evidence which
shows that all parts of plant and equipment work with in their
specifications and process parameters.
 Performance Qualification-document evidence that all parts
of plant and other processes produce products of specified
quality under conditions of normal production for a
longer period  of time.
INSTRUMENTATION OF UV
VISIBLE
SPECTROPHOTOMETER
LEVEL II INSTALLATION
PROCEDURE
 When the UV instrument was shipped after the precise adjustment and inspection at the factory,
it is recommended to install according to procedure to provide optimum performance.
 Installation site-
 Room temperature during use of 15 to 30°c
 Out of direct sunlight
 No strong vibration or continuous weak vibration
 No strong magnetic fields
 No corrosive gases or organic or inorganic gases with absorptivity in the UV region
 Small amount of dust
 Humidity of 45 to 80%
LEVEL III PERFORMANCE
QUALIFICATION
PARAMETERS
Parameters to be checked
               
Typical acceptance limits

•  Spectral silt width              ±10%

• Wavelength accuracy 0.05nm

• Wavelength precision 0.01nm

• Absorbance accuracy

• Photometric linearity

• Limit of stray light

• Baseline noise ±0.002AU

• Photometric drift ±0.001AU

PERFORMANCE
QUALIFICATION PARAMETERS

• Spectral silt width- the silt width must

be small compared with half width of
the absorption band but it must be large
as possible to obtain high value of I0
SPECTRAL SILT WIDTH
 Method and limits

1. Switch the system on and start the Scan module. 

2. Select SETUP and set the following parameters:
•      X Mode = Nanometers 
•      Start wavelength = 660.0 nm 
•      Stop wavelength = 650.0 nm
•      Y Mode = % T 
•      Scan rate = 10 nm/min 
•      Gain = (100) see 4 below

3. Select Options tab and set the  following parameters: 

•       SBW = 4 nm 
•       Beam mode = Single front
•        Lamps on = Deuterium 
•       Source change = 700.0 nm
 SPECTRAL SILT WIDTH
 Method and limits

4.   Start scan and examine the trace for a peak around 656.1 nm.

5.   Measure spectral band width which should be with in ± 10%

6.   Check the calibration at a silt width of 0.2nm If silt width is too small –instrument have more photometric
noise.
 WAVELENGTH PRECISION
 It is defined as deviation of wavelength reading at an absorption band and emission band from the
wavelength band.
 Materials -
   Holonium perchlorate solution R -40g/L of Holonium oxide in 14g/L solution of perchloric acid.
 Mercury lamp
 Certified filters
 Method - Carry out 6 measurements of absorption maxima.
 Limit -
 Repeatability - The RSD of absorption maxima should satisfy manufacture specifications.
      the difference between 6 individual absorption maxima should be < 0.5nm.
BASELINE NOISE
 The flat baseline test shows the ability of instrument to normalize light intensity measurements
and spectral output at different wavelength throughout spectral range.
 Method
 Make 61 absorbance measurements with an integration time of one second at wavelength of
500nm, with no sample in the sample chamber and calculate the mean. 
 Acceptance limit is <0.01 AU.
PHOTOMETRIC DRIFT  
 It should be checked in both UV and Visible region ,at appropriate wavelength.
 It is determined by comparing difference between measured absorbance of reference material
and established value.
 Method-
 As routine test the drift is measured at 250 nm over a period of 2 hours by using the time scan
mode of instrument, with no sample in the chamber.
 Limit-   ±0.001AU
 LEVEL IV IN USE
INSTRUMENT CHECKS
Parameter to be checked Typical acceptance limits

System suitability check of the method - According to Ph. Eur. 

 e.g. Repeatability 
 e.g. Resolution (if required for qualitative analysis) 
                                                            

Control of cuvettes According to ph..Eur.

LEVEL IV IN USE
INSTRUMENT CHECKS
 SYSTEM SUITABILITY TEST OF THE METHOD
 REPEATABILITY (for quantitative analysis)
  RESOLUTION (for both qualitative and quantitative analysis)
  Method- repeatability 
 Measure concentrations of 6 independently prepared sample solutions of 100%of the assay test
concentrations.
 Limit 
 The RSD is NMT1% for drug substance
                     NMT 2% for drug product
                     NMT 20%for impurity analysis
THANK YOU