Q.P. CODE : 9294
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
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LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Explain the bioassay of the following:
(a) Chorionic gonadotropin.
(b) Vasopressor activity.
(c) Urokinase. - Explain the various techniques of microbiological assay of antibiotics with any one suitable example.
- Give an account on the validation of HPLC analytical method as per ICH guidelines.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write methodology of sterility testing.
- Write the quality control tests for any two radiopharmaceuticals.
- What is the principle of Differential Thermal analysis? How does it differ from Differential Scanning Calorimetry? Explain Differential Thermogram and application of Differential Thermal analysis specifically to formulation development.
- Write the principle and the technique of microbiological assay of vitamins by turbidimetry by taking any one vitamin as example.
- Explain the production and chemical nature of pyrogen and LAL test.
- Explain the applications of mass spectrometry to the quantitative analysis.
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SHORT NOTES 2 X5 = 10 Marks
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- Endotoxin and exotoxin.
- Refractive index.
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