ContrΓ΄le QualitΓ© Pharmaceutique Test

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ContrΓ΄le QualitΓ© Pharmaceutique Test

 

1 / 60

What is Conformance to specification means?

2 / 60

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

3 / 60

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‹

4 / 60

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

5 / 60

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

6 / 60

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?

7 / 60

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

8 / 60

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

9 / 60

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

10 / 60

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?

11 / 60

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?

12 / 60

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?

13 / 60

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

14 / 60

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

15 / 60

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?

16 / 60

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?

17 / 60

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)

18 / 60

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

19 / 60

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

20 / 60

Which form of drug formulation has pH in specification?

21 / 60

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

22 / 60

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

23 / 60

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…?

24 / 60

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?

25 / 60

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

26 / 60

DΓ©finition de la spΓ©cification ?

27 / 60

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?

28 / 60

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—?

29 / 60

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

30 / 60

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

31 / 60

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?

32 / 60

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

33 / 60

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?

34 / 60

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

35 / 60

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

36 / 60

Which form of drug formulation has disintegration time?

37 / 60

What is QC in pharmaceutical industrials?

38 / 60

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

39 / 60

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?

40 / 60

When need calibration of glassware? Choose incorrect answer.

41 / 60

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

42 / 60

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?

43 / 60

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

44 / 60

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?

45 / 60

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?

46 / 60

Why are standard operating procedures important?

47 / 60

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?

48 / 60

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

49 / 60

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

50 / 60

La monographie est ?

51 / 60

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

52 / 60

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

53 / 60

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

54 / 60

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

55 / 60

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…?

56 / 60

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

57 / 60

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

58 / 60

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

59 / 60

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

60 / 60

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

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