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PHARMACEUTICAL ANALYSIS ---KUNAL BHAMARE.pptx

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PHARMACEUTICAL ANALYSIS ---KUNAL BHAMARE.pptx

  1. 1. PRACTICE SCHOOL
  2. 2.  PHARMACEUTICAL ANALYSIS Different Analytical Instrument
  3. 3. Review Article By: Bhamare Kunal Shivaji Final Year B. Pharmacy P.R.N NO- (2052811823003) Guided By: Prof. Kalyani Dhavale
  4. 4.  Pharmaceutical Analysis Of Different Analytical Instrument
  5. 5.  ANALYTICAL TECHNIQUE  AIM  INTRODUCTION  DIFFERENT ANALYTICAL INSTRUMENT  REGULATORY GUIDELINES  QC/QA/GLP INTRODUCTION ICH GUIDELINES  CONCLUSION  REFERANCE
  6. 6. Pharmaceutical analysis = is a broader term which can be defined in many ways. It is the series of processes that are used for identification, determination, separation, purification, and structure elucidation of the given compound used in the formulation of pharmaceutical products. Qualitative Analysis Quantitative Analysis
  7. 7.  it is a method used to determine a chemical or physical property of a chemical substance, chemical element, or mixture  There is a wide variety of techniques used for analysis, from simple weighing to advanced techniques using highly specialized instrumentation.
  8. 8.  U.V  FLAME PHOTOMETRY  PH METER
  9. 9. Ultraviolet-visible (UV-Vis) spectrophotometer is a technique used to measure light absorbance across the ultraviolet and visible ranges of the electromagnetic spectrum
  10. 10.  In a double beam UV visible spectrophotometer, only light of a specific wavelength is extracted from the double beams or resulting spectrum. The light rays are extracted from the exit slit opening of the spectrophotometer device. The monochromatic light intensity irradiates the samples and intensity is detected.
  11. 11.  The double beam spectrophotometer uses an infrared thermometer and photometers to measure absorbance versus wavelength to detect the color of the sample. The absorbance measurement is the ratio of the sample to the reference beams
  12. 12.  Calibration determines that a device or instrument is producing accurate results within the specified limits compared to those produced by a traceable standard.
  13. 13.  Validation is the procedure which authorizing documentary evidences that prove, the following process/ method or activity will consistently produce the product which leads to the expected result (predetermined requirements).  Types of validation:  Analytical validation  Process validation  Cleaning validation  Equipment validation
  14. 14.  INTRODUCTION- Flame photometry is defined as the measurement of intensity of the light emitted when any alkali or earth metal is introduced into the flame. Because of the emission of radiation, it is also known as flame emission spectroscopy.
  15. 15.  Flame Photometry works by measuring the intensity of light emitted (measured using a wavelength of a colour ) when the element is exposed to a Flame. Flame Photometer Components: There are four basic components to a Flame Photometer– a flame, nebulizer and mixing chamber, colour filters, and a photo detector.
  16. 16. The photometers have to be calibrated to get a correlation between signal and concentration or to compare readings among different photometers. Therefore a method must be established that produces a stable and reproducible readout.
  17. 17.  A pH meter is an instrument used to measure acidity or alkalinity of a solution - also know as PH. PH is the unit of measure that describes the degree of acidity or alkalinity.
  18. 18.  A PH meter works by measuring the electrical potential (voltage) produced by the solution being tested, using the potential difference to determine the PH.
  19. 19.  A pH calibration is the process of adjusting your pH meter by measuring solutions of a known PH value. This is because the characteristics of your electrode will change over time and this needs to be compensated for. A calibration does this by matching your pH meter to the current characteristics of your pH sensor.
  20. 20.  Regulatory Guidelines means applicable rules, guidance, manuals, protocols, codes, guidelines, treaties, policies, notices, directions, decrees, judgments, awards or requirements, in each case of any Regulatory Authority to the extent that the foregoing do not have the force of law.
  21. 21. The term quality control refers to the sum of procedures undertaken to ensure the identity and purity of a particular pharmaceutical product.
  22. 22. Quality Assurance (QA) activities include a planned system of review procedures conducted by personnel not directly involved in the inventory development process.
  23. 23. Good Laboratory Practices is a quality system concerned with the organizational process and the conditions under which a study is planned, performed , monitored, recorded, archived and reported.
  24. 24.  1 Stability  2 Analytical validation  3 Impurities  4 Pharmacopoeias  5 Qaulity of Biotechnological product  6 Specifications  7 GMP  8 Pharmaceutical Development  9 Quality Risk Management  10 Pharmaceutical Qaulity System  11 Development And Manufacture Of Drug Substances  12 Lifecycle management  13 Continuous Manufacturing Of Drug Substances And Drug Product  14 Analytical Procedure Development
  25. 25.  In this review attempt is made to incorporate various analytical instruments and their principle with their detail instrument analytical Instruments like i.e. Ultraviolet spectroscopy, flame photometer, PH meter, They are used often because of its speed,simplicity and availability. It has applications in various chemical and drug analysis.
  26. 26.  R. Chatwal, Sham K. Anand; A text book of instrumental methods of chemical analysis; Page. No:1.2-1.3, 2.367-2.377.,2.340-2.3452.  Jeffe Gurdeep r.y, G. H., Basset, J., Mendham, J., Denney, R. In; Vogel’s Textbook of Quantitative Analysis, 5thEdn., Longman Scientific and Technical, 1999, 10.  Pavia, D. L., Lampman, G. M., Kriz, G. S.,Introduction to Spectroscopy,3rdEdn., Harcourt College Publishers 2006, 353.  Connor, K. A., Text Book of Pharmaceutical Analysis,2ndEdn., Mac Publishing Co., Pennsylvania1980, 173.
  27. 27.  Instrumental method of analysis Popular PrakashanMumbai.Page no.192-198. A PanchumarthyRavisankar A Review on Step-by-Step SupriyaS.Mahajan nalytical Method Validation, IOSR Journal Of Pharmacy (Volume 5, Issue 10 (October 2015), PP. 07-19.  Dhurba Giri from laboratoryinfo.com. July 2015.  Md. JahaSultana,A Complete Review On Nuclear  Magnetic Resonance (Nmr) Pharmatutor-Art-2076 Y.Anjaneyulu, K.chandra Sekhar Valli Manikam; A  Text book of Analytical Chemistry; Page. No: 682 – 712.)  Willard, Merritt Dean; seltte; Instrumental method of analysis; 6th edition; Page. No: 422 –454.

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