Definition of calibration & validation and calibration of IR
Size: 326.04 KB
Language: en
Added: Mar 09, 2021
Slides: 16 pages
Slide Content
Presented By: Netra Prasad Neupane 17BPH080 B.Pharmacy (8 th semester) Presented To: Prof. ( Dr.) P. Malairajan FHS, SIHAS SHUATS Presentation on: CALIBRATION OF IR SPECTROPHOTOMETER . SAM HIGGINBOTTOM UNIVERSITY OF AGRICULTURE TECHNOLOGY AND SCIENCES, PRAYAGRAJ ADVANCED INSTRUMENTATION TECHNIQUES BP811ET 8 March 2021 1
INTRODUCTION Validation : 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 intended analytical applications. Equipment validation: Demonstrate that equipment used in validation studies is suitable for use and is comparable to equipment used for routine analysis Calibrated (as applicable) Qualifications should have been performed. Installation Qualification Operation Qualification Performance Qualification 8 March 2021 2
Method validation: Process Validation: It is documented program which provides a high degree of assurance that a specific process will consistently produce a desired result/ product meeting its predetermined specifications and quality characteristics. It is the process of demonstrating that analytical procedures are suitable for their intended use. 8 March 2021 3
DEFINATION According to ICH : Calibration: It demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements. Validation : 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 intended analytical applications. 8 March 2021 4
Why should be Calibrated? These should be calibrated for the following ways. To ensure the Reliability of the instrument. To determine the accurancy of the instrument. To ensure the Reading are consistent with other instrument. 8 March 2021 5
Need for calibration Calibration can be called for: With a new instrument When a specified time period is elapsed. When a specified usage (operating hours) has elapsed. When an instrument has had a shock or vibration which potentially may have put it out of calibration. 9 March 2021 6
Sudden changes in weather. Whenever observations appear questionable. 9 March 2021 7
IR Spectrophotometer IR spectroscopy is the spectroscopy that deals with the infrared region of the electromagnetic spectrum, that is light with a longer wavelength and lower frequency than visible light. Infrared spectroscopy (IR) measures the bond vibration frequencies in a molecule and is used to determine the functional groups. The infrared region of the spectrum encompasses radiation with wave numbers ranging from about 12,500 to 50 cm -1 (or) wavelengths from 0.8 to 200 µ. Infrared region lies between visible and microwave region. Infrared spectroscopy is the analysis of infrared light interacting with a molecule. It is based on absorption spectroscopy. 8 March 2021 8
Infrared Region Near infrared region 0.8- 2.5 µ (12,500-4000 cm-1) Main infrared region 2.5-15 µ (4,000-667 cm-1) Far infrared region 15-200 µ (667-100 cm-1) 9 March 2021 9
Calibration of IR spectroscopy Wave number verification Resolution performance 9 March 2021 10
Wave number verification Prepare polystyrene film with thickness 0.04 mm and verify the wave number. 9 March 2021 11 Observed wavenumber Minimum tolerance Maximum tolerance 3058.5 3061.5 2848.0 2851.0 1941.4 1944.4 1600.2 1602.2 1582.0 1584.0 1153.5 1155.5 1027.3 1029.3
Resolution performance Difference between % T at 2851 Cm-1 and 2870 Cm-1 Difference between % T at 1583 Cm -1 and 1589 Cm-1 Limit NLT 18% NLT 12% Actual 9 March 2021 12
Application of IR spectroscopy Structure determination 9 March 2021 13
Identification of substances Determination of molecular structure . Detection of impurities Progress of reactions Presence of water in sample Application in industry 9 March 2021 14
REFERENCE Aparna C, Gowrisankar D. a Review on Calibration of Analytical Instruments. Int J Pharm Chem Biol Sci. 2015;5(3):573–82. Günzler , Helmut, and Hans-Ulrich Gremlich . "IR spectroscopy. An introduction." (2002). 9 March 2021 15