ContrΓ΄le QualitΓ© Pharmaceutique Test

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ContrΓ΄le QualitΓ© Pharmaceutique Test

 

1 / 60

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

2 / 60

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

3 / 60

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

4 / 60

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

5 / 60

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

6 / 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…?

7 / 60

Analytical method can be divided into two main types?

8 / 60

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

9 / 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?

10 / 60

What is Conformance to specification means?

11 / 60

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›?

12 / 60

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

13 / 60

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

14 / 60

Which form of drug formulation has pH in specification?

15 / 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?

16 / 60

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

17 / 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?

18 / 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…?

19 / 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?

20 / 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?

21 / 60

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

22 / 60

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

23 / 60

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

24 / 60

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

25 / 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?

26 / 60

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

27 / 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?

28 / 60

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

29 / 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‹

30 / 60

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

31 / 60

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

32 / 60

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

33 / 60

Why are standard operating procedures important?

34 / 60

Which form of drug formulation has disintegration time?

35 / 60

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…?

36 / 60

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

37 / 60

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

38 / 60

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

39 / 60

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

40 / 60

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

41 / 60

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

42 / 60

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

43 / 60

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‡?

44 / 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—?

45 / 60

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

46 / 60

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

47 / 60

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

48 / 60

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

49 / 60

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

50 / 60

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

51 / 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?

52 / 60

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

53 / 60

When need calibration of glassware? Choose incorrect answer.

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

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

56 / 60

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“?

57 / 60

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

58 / 60

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

59 / 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?

60 / 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 ?

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