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IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY

IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY. TOTAL QUALITY CONTROL (TQC ). CONVENTIONAL QUALITY CONTROL: End Product TOTAL QUALITY CONTROL: At every stage of the process FOR OTHER INDUSTRY TQC IS A BUSINESS TOOL

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IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY

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  1. IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY Presented at PITTCON 2003, March 9-14 Orlando Florida

  2. TOTAL QUALITY CONTROL (TQC) • CONVENTIONAL QUALITY CONTROL: End Product • TOTAL QUALITY CONTROL: At every stage of the process • FOR OTHER INDUSTRY TQC IS A BUSINESS TOOL • PHARMACEUTICAL INDUSTRYTQCIS LEGAL REQUIRMENT; USA FEDERAL FOOD, DRUG AND COSMETIC ACT Presented at PITTCON 2003, March 9-14 Orlando Florida

  3. TECHNIQUES • LISTED IN UNITED STATES PHARMACOPEIA • WET CHEMSITRY • IR,VIS,UV, ABSORPTION/FLUORESCENCE • SPECTROMETRY • LIGHT SCATTERING • MASS SPECTROMETRY • CHROMATOGRAPHY • NMR (CW/FTR) • X-RAY FLUORESCENCE/DIFFRACTION Presented at PITTCON 2003, March 9-14 Orlando Florida

  4. WHY NEW TECHNIQUE • All these techniques need sample preparation • Most of the operating costs and time are spent on the preparation of the sample for injection in the measurement device • Waste storage, segregation and disposal of chemicals/solvents • We need a technique which needs no sample preparation Presented at PITTCON 2003, March 9-14 Orlando Florida

  5. LASER INDUCED BREAKDOWN SPECTROSCOPY(LIBS) • Almost no sample preparation • Several elements can be monitored simultaneously • Results are available almost immediately • Optical fibers make it more convenient Presented at PITTCON 2003, March 9-14 Orlando Florida

  6. PROBLEMS WITH LIBS • Process involved • ablation, atomization and excitation are complex and difficult to reproduce • Careful optimization of experimental parameters to achieve detection limits and accuracy better /comparable with the alternate techniques Presented at PITTCON 2003, March 9-14 Orlando Florida

  7. SAMPLES • . • wt% inwt% inwt% inwt% in • Amount of brand Abrand Bbrand Cbrand D • 99.99% • CaCO3 • Ca NaCaCa MgCa • 10 tablets+0g 14.20 0.2515.8015.10 3.1218.53 • 10 tablets+1.00g 15.43 0.2417.6216.02 2.8820.09 • 10 tablets+2.00g 16.54 0.2319.1917.59 2.8021.43 • 10 tablets+3.00g 17.56 0.22 20.5518.29 2.6222.66 • 10 tablets+4.00g 18.48 0.21 21.7419.51 2.5324.85 • 10 tablets+5.00g 19.36 0.20 22.8420.24 2.4025.58 Presented at PITTCON 2003, March 9-14 Orlando Florida

  8. EXPERIMENTAL SETUP Presented at PITTCON 2003, March 9-14 Orlando Florida

  9. OPTIMIZATION OF FOCAL SPOT Presented at PITTCON 2003, March 9-14 Orlando Florida

  10. DELAY TIME Presented at PITTCON 2003, March 9-14 Orlando Florida

  11. SAMPLE ROTATION Presented at PITTCON 2003, March 9-14 Orlando Florida

  12. Absolute Intensity • Iji = nX(hc/lji){gj/Q(T)}Aji Exp[-Ej/kT] • Or • Iji = nXK • Which is a linear relation Presented at PITTCON 2003, March 9-14 Orlando Florida

  13. INTENSITY RATIO • (Iji)x = nX(hc/lji)x[{gj/Q(T)}Aji]x Exp[-Ej/kT]x • (Imn)y=nY(hc/lmn)Y[{gm/Q(T)}Amn]Y Exp[-Em/kT]Y • Temperature dependence of Q is neglected • T(x) =T(Y) ~Te • [(Iji)x]/[(Imn)y= constant[nX/nY] Presented at PITTCON 2003, March 9-14 Orlando Florida

  14. LIBS SPECTRUM IN 380-400 nm REGION Presented at PITTCON 2003, March 9-14 Orlando Florida

  15. LIBS SPECTRUM IN 320-340 nm REGION Presented at PITTCON 2003, March 9-14 Orlando Florida

  16. CALIBRATION FOR ACTIVE INGREDIENT Ca Presented at PITTCON 2003, March 9-14 Orlando Florida

  17. CALIBRATION FOR ACTIVE INGREDIENT Mg Presented at PITTCON 2003, March 9-14 Orlando Florida

  18. CALIBRATION FOR IN-ACTIVE INGREDIENT Na Presented at PITTCON 2003, March 9-14 Orlando Florida

  19. CALIBRATION FOR IMPURITY Al Presented at PITTCON 2003, March 9-14 Orlando Florida

  20. CONCLUSIONS • LIBS CAN BE USED IN TQC TO: • SIMULTANEOUSLY MONITOR ON-LINE • 1. ACTIVE INGREDIENTS • 2. INACTIVE INGREDIENTS • 3. IMPURITIES • OF PHARMACEUTICAL PRODUCTS Presented at PITTCON 2003, March 9-14 Orlando Florida

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