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ContrΓ΄le QualitΓ© Pharmaceutique Preparation (Pr. Tout Sokhom)

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1) Why are standard operating procedures important?

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2) 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?

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3) αžαžΎαž™αžΎαž„αž€αŸ†αžŽαžαŸ‹ αž…αŸ†αž“αž½αž“αž“αžΆαž‘αžΈαž“αž·αž„αž‡αž»αŸ† αž‘αŸ…αž›αžΎαž§αž”αž€αžšαžŽαŸβ€‹ Friability tester αžŠαžΌαž…αž˜αŸ’αžαŸαž…αž˜αž»αž“αž–αŸαž›αž…αžΆαž”αŸ‹αž•αŸ’αžαžΎαž˜αžŠαŸ†αžŽαžΎαžšαž€αžΆαžš?

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4) αžαžΎαž€αžΆαžšαž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Dissolution αžαŸ’αžšαžΌαžœαž’αž“αž»αžœαžαŸ’αžαž“αŸαž”αžΆαž“αž“αŸ…αžŸαžΈαžαž»αžŽαŸ’αž αž—αžΆαž–αž”αŸ‰αž»αž“αŸ’αž˜αžΆαž“?

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5) αžαžΎαž“αŸ…αž–αŸαž›αžŽαžΆαž‘αžΎαž”αž’αŸ’αž“αž€αž’αžΆαž…αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžαžΆαž±αžŸαžαžŠαŸ‚αž›αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž αž‡αžΆαž”αŸ‹ Uniformity of weight?

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6) αž€αŸ’αž“αž»αž„αž€αžšαžŽαžΈαž’αŸ’αž“αž€αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Disintegration αž…αŸ†αž“αž½αž“ 6 αž‚αŸ’αžšαžΆαž”αŸ‹ αž˜αžΆαž“αŸ‘αž‚αŸ’αžšαžΆαž”αŸ‹αž’αŸ’αž›αžΆαž€αŸ‹αž…αŸαž‰αž–αžΈ Limit acceptable αŸ” αžαžΎαž’αŸ’αž“αž€αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžŠαžΌαž…αž˜αŸ’αžαŸαž…?

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7) αžαžΎαž±αžŸαžαž”αŸ’αžšαž—αŸαž‘αžŽαžΆαžαŸ’αž›αŸ‡αžαž˜αŸ’αžšαžΌαžœαž±αŸ’αž™αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Uniformity of weight? (αžšαž€αž…αž˜αŸ’αž›αžΎαž™αžαž»αžŸ)

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8) The requirements of the test disintegration are met if not less than 16 of the 18 dosage units
tested have disintegrated for uncoated tablet?

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

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10) αžαžΎαž“αŸ…αž–αŸαž›αžŽαžΆαž‘αžΎαž”αž™αžΎαž„αž’αŸ„αž™αž›αž‘αŸ’αž’αž•αž›αž‡αžΆαž”αŸ‹αžαŸαžŸαŸ’αž Friability?

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11) αžŠαžΎαž˜αŸ’αž”αžΈαžœαž·αž—αžΆαž‚αžšαž€αž”αžšαž·αž˜αžΆαžŽαžŸαžΆαžšαž’αžΆαžαž»αžŸαž€αž˜αŸ’αž˜αž±αžŸαž (Dossage/Assay) αžαžΎαž˜αžΆαž“αžœαž·αž’αžΈαžŸαžΆαžŸαŸ’αžšαŸ’αž (Method) αž’αŸ’αžœαžΈαžαŸ’αž›αŸ‡?

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12) Which one is the correct sequence for drug absorption through the oral route?

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13) What is QC in pharmaceutical industrials?

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14) For identification of the unknown sample by spectrophotometry, what is the information we
need from the measurement?

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

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

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17) 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?

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

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19) 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?

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20) What is the Concentration in C% (W/V) of 4g NaOH, 100ml?

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21) Test Dissolution αž‚αžΊαž’αŸ’αžœαžΎαžŠαžΎαž˜αŸ’αž”αžΈ?

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22) La référentiels de la qualité des matières premières peut trouver dans ?

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23) Test Disintegration αž‚αžΊαž’αŸ’αžœαžΎαžŠαžΎαž˜αŸ’αž”αžΈ?

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

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25) What is the Concentration in mol/L of 0.1g NaOH , 250ml?

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26) The range of concentration for analytical method validation is normally set between?

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

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

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29) Test microbiologique (qualitΓ© microbienne) des produits pharmaceutiques est un test qui ?

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30) αžαžΎαž€αžΆαžšαž€αŸ†αžŽαžαŸ‹ Limit acceptable αž“αŸ…αž€αŸ’αž“αž»αž„ Uniformity of weight αž‚αŸαž€αŸ†αžŽαžαŸ‹αž‘αžΎαž„αžŠαžΌαž…αž˜αŸ’αžαŸαž…αžαŸ’αž›αŸ‡ αž…αŸ†αž–αŸ„αŸ‡αž‘αŸ†αžšαž„αŸ‹αž±αžŸαžαž“αžΈαž˜αž½αž™αŸ—?

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

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32) In the assay of paracetamol tablet, what are the solutions need to run in spectrophotometer?

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33) 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?

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34) αž€αŸ’αž“αž»αž„αž€αžšαžŽαžΈαž’αŸ’αž“αž€αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αžβ€‹ Disintegration αž…αŸ†αž“αž½αž“ 6 αž‚αŸ’αžšαžΆαž”αŸ‹ αž˜αžΆαž“αŸ£αž‚αŸ’αžšαžΆαž”αŸ‹αž’αŸ’αž›αžΆαž€αŸ‹αž…αŸαž‰αž–αžΈ Limit acceptableαŸ” αžαžΎαž’αŸ’αž“αž€αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžŠαžΌαž…αž˜αŸ’αžαŸαž…?

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

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36) 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?

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37) αž€αŸ’αž“αž»αž„αž€αžšαžŽαžΈαž’αŸ’αž“αž€αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Uniformity of weight αž…αŸ†αž“αž½αž“αŸ’αŸ αž‚αŸ’αžšαžΆαž”αŸ‹αž˜αžΆαž“αŸ£αž‚αŸ’αžšαžΆαž”αŸ‹αž’αŸ’αž›αžΆαž€αŸ‹αž…αŸαž‰αž–αžΈ Limit αž‘αžΈαŸ‘αŸ” αžαžΎαž’αŸ’αž“αž€αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžŠαžΌαž…αž˜αŸ’αžαŸαž…?

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38) The methodology of calibration of glassware are? Choose incorrect answer.

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

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40) La monographie est ?

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

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42) 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?

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

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44) DΓ©finition de la spΓ©cification ?

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45) 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?

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46) Which form of drug formulation has pH in specification?

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47) αžαžΎαž€αžΆαžšαž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Disintegration αžαŸ’αžšαžΌαžœαž’αž“αž»αžœαžαŸ’αžαž“αŸαž”αžΆαž“αž“αŸ…αžŸαžΈαžαž»αžŽαŸ’αž αž—αžΆαž–αž”αŸ‰αž»αž“αŸ’αž˜αžΆαž“?

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48) The finished products containing active ingredients should comply with ……………….
composition of the marketing authorization.?

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49) Which form of drug formulation has disintegration time?

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

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

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52) αž€αŸ’αž“αž»αž„αž€αžšαžŽαžΈαž™αžΎαž„αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Friability αž–αŸαž›αž§αž”αž€αžšαžŽαŸαžŠαŸ†αžŽαžΎαžšαž€αžΆαžšαž…αž”αŸ‹ αž˜αžΆαž“αžαŸ’αž“αžΆαŸ†αŸ‘αž‚αŸ’αžšαžΆαž”αŸ‹αž”αŸ‚αž€αž‡αžΆαŸ’ αžαžΎαž™αžΎαž„αž•αŸ’αžαž›αŸ‹αž›αž‘αŸ’αž‹αž•αž›αžŠαžΌαž…αž˜αŸ’αžαŸαž…?

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53) αžαžΎαž“αŸ…αž–αŸαž›αžŽαžΆαž‘αžΎαž”αž’αŸ’αž“αž€αž’αžΆαž…αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžαžΆαž±αžŸαžαžŠαŸ‚αž›αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž αž’αŸ’αž›αžΆαž€αŸ‹ Uniformity of weight?

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

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

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

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57) 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?

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58) When need calibration of glassware? Choose incorrect answer.

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59) We prepare the indicator solution of potassium chromate (K2CrO4, MM = 194.19 g/mol) 5%
(W/V) in 100ml of water, we weight mK2CrO4 ?

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

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61) 35- Test uniformity of weight, the deviation of individual masses from the average mass 80 mg to
250 mg should not exceed the limits given below?

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62) In process control (ContrΓ΄le en cours de la fabrication) αž’αŸ’αžœαžΎαžŠαžΎαž˜αŸ’αž”αžΈ?

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

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64) La Module 3 du dossier CTD (ou ACTD) est dΓ©crit des informations concernent ?

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65) Test uniformity of weight, the deviation of individual masses from the average mass less than 80
mg should not exceed the limits given below?

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66) The requirements of the test disintegration are met if not less than 16 of the 18 dosage units
tested have disintegrated for coated tablet?

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67) Les paramΓ¨tres doivent Γͺtre Γ©crit dans la monographie sont suivent, excepte ?

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

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69) αž“αŸ…αž–αŸαž›αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Disintegration αžαžΎαž’αŸ’αž“αž€αžŸαž„αŸ’αž€αŸαžαž˜αžΎαž›αžšαž”αŸ€αž”αž˜αž·αž… αž‘αžΎαž”αž€αžαŸ‹αž™αž€αž“αžΆαž‘αžΈαž‡αžΆαž›αž‘αŸ’αž’αž•αž›?

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

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71) 36- Test uniformity of weight, the deviation of individual masses from the average mass more
than 250 mg should not exceed the limits given below?

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

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

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74) αžŠαžΎαž˜αŸ’αž”αžΈαžšαž€αž—αžΆαž‚αžšαž™αž“αŸƒαž—αžΆαž–αžŸαž»αž‘αŸ’αž’ (Purity) αžšαž”αžŸαŸ‹αžœαžαŸ’αžαž»αž’αžΆαžαž»αžŠαžΎαž˜ αž™αžΎαž„αžαŸ’αžšαžΌαžœαž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž?

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75) What is Conformance to specification means?

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

77 / 82

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

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78) αžαžΎαž™αžΎαž„αžαŸ’αžšαžΌαžœαž™αž€αžαŸ’αž“αžΆαŸ†αž”αŸ‰αž»αž“αŸ’αž˜αžΆαž“αž‚αŸ’αžšαžΆαž”αŸ‹αž‘αŸ…αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αž Friability? αžŸαžΌαž˜αž”αž‰αŸ’αž‡αžΆαž€αŸ‹

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

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80) Analytical method can be divided into two main types?

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81) Which form of drug formulation need to evaluate for dissolution percentage?

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82) αž€αŸ’αž“αž»αž„αž€αžšαžŽαžΈαž’αŸ’αž“αž€αž”αžΆαž“αž’αŸ’αžœαžΎαžαŸαžŸαŸ’αžβ€‹ Uniformity of weight αž…αŸ†αž“αž½αž“αŸ’αŸ αž‚αŸ’αžšαžΆαž”αŸ‹ αž˜αžΆαž“αŸ‘αž‚αŸ’αžšαžΆαž”αŸ‹αž’αŸ’αž›αžΆαž€αŸ‹αž…αŸαž‰αž–αžΈ Limit αž‘αžΈαŸ’αŸ” αžαžΎαž’αŸ’αž“αž€αžŸαž“αŸ’αž“αž·αžŠαŸ’αž‹αžΆαž“αžŠαž½αž…αž˜αŸ’αžαŸαž…?

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