Contrôle qualité 02 (40-82)

40. What is QC in pharmaceutical industrials?

41. Which one of these is a physicochemical property of Drug substance (raw materials)?

42. Which one of these is a physicochemical property of Drug product (finished product)?

43. Which form of drug formulation has disintegration time?

44. Which one of these is a microbiological property of Drug product (finished product)?

45. Which one of these is a microbiological property of Drug product (finished product)?

46. Which form of drug formulation need to evaluate for dissolution percentage?

47. Which one is the correct sequence for drug absorption through the oral route?

48. Which form of drug formulation has pH in specification?

49. Which one of these is a physicochemical test of Drug substance (Raw materials)?

50. Which one of these is a physicochemical test of Drug product (finished product)?

51. Which one of these is a physicochemical test of Drug product (finished product)?

52. Which one of these is a physicochemical test of Drug product (finished product)?

53. Which of the following is not correct about High pressure liquid chromatography (HPLC)?

54. Which one of these is a physicochemical test of Drug substance (Raw materials)?

55. Which one of these physicochemical tests, is not test of Drug product (finished product)?

56. Which one of these physicochemical tests, is not test of Drug product (finished product)?

57. Which one of these physicochemical tests, is not test of Drug product (finished product)?

58. Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?

59. Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?

60. Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?

61. Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?

62. Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?

63. Which statement best describes a standard operating procedure (SOP)?

64. Why are standard operating procedures important?

65. When need calibration of glassware? Choose incorrect answer.

66. The methodology of calibration of glassware are? Choose incorrect answer.

67. The calibration based on the direct mass measurement of water delivered by a pipet or contained in a volumetric flask and conversion to volume with the density, at the specified temperature is the methodology of?

68. The calibration based on a calibrated vessel is used as a reference in the calibration of an unknown vessel, is sometime used when many glassware items are to be calibrated is the methodology of?

69. The parameters need to be validated for new analytical method development in order to identification of chemical compounds is?

70. The parameters need to be validated for new analytical method development in order to testing for limit of impurities are?

71. The parameters need to be validated for new analytical method development in order to assay of chemical compounds are included, except?

72. The ability of an analytical method to distinguish analyte from everything else that might be in the sample is the definition of?

73. The ability of an analytical method to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample is the definition of?

74. The ability of an analytical method to demonstrate how closely the result of an experiment agrees with the expected result is the definition of?

75. The ability of an analytical method is how well replicate measurements agree with one another, usually expressed as a standard deviation is the definition of?

76. The ability of an analytical method is how well replicate measurements agree with one another, usually expressed as a standard deviation, express within-laboratories variations: different days, different analysts, different equipment, etc. Is the definition of?

77. The ability of an analytical method is how well replicate measurements agree with one another, usually expressed as a standard deviation, express under the same operating conditions over a short interval of time, etc. Is the definition of?

78. The ability of an analytical method is the lowest amount of analyte in a sample which can be detected, is the definition of?

79. The ability of an analytical method is the lowest concentration of analyte that can be measured in the sample matrix at an acceptable level of precision and accuracy, is the definition of?

80. The interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity, is the definition of?

81. The range of concentration for analytical method validation is normally set between?

82. In the validation method for assay of paracetamol tablet by spectrophotometer at wavelength 257nm, the solution to be prepared are? Except