問題一覧
1
La Module 3 du dossier CTD (ou ACTD) est décrit des informations concernent ?
La qualité
2
Définition de la spécification ?
Liste d'analyses avec les références à des procédures analytiques et les critères d'acceptation appropriées
3
La référentiels de la qualité des matières premières peut trouver dans ?
- Les Pharmacopées
4
La monographie est ?
- document qui est écrit des paramètres des tests et des spécifications des substances inscrits dans la pharmacopée
5
Les paramètres doivent être écrit dans la monographie sont suivent, excepte ?
- Le fabricant
6
តើឱសថប្រភេទណាខ្លះតម្រូវអោយធ្វើតេស្តUniformity of weight? (រកចម្លើយខុស)
- Sirop
7
តើការកំណត់Limit acceptableនៅក្នុងUniformity of weight គេកំណត់ឡើងដូចម្តេចខ្លះ ចំពោះទំរង់ឱសថនីមួយៗ?
ផ្អែកលើ Average Weight របស់ទំរង់ថ្នាំនីមួយៗ ដែលមានទំងន់ <80mg ឬនៅចន្លោះ 80mg- 250mg ឫ >250mg
8
តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលធ្វើតេស្តជាប់Uniformity of weight?
ក្នុងគ្រាប់ថ្នាំ២០គ្រាប់ មាន១៨គ្រាប់យ៉ាងតិចជាប់ក្នុងlimit ទី១ និងមាន២គ្រាប់យ៉ាងច្រើន អាចធ្លាក់ចេញពីlimitទី១ ប៉ុន្តែមិនត្រូវធ្លាក់ចេញពីlimitទី២នោះទេ
9
តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលធ្វើតេស្ត ធ្លាក់Uniformity of weight?
មានគ្រាប់ថ្នាំ2គ្រាប់ធ្លាក់ចេញពីlimitទី១ និងធ្លាក់ចេញពីlimitទី២ ឬ មាន៣គ្រាប់ធ្លាក់ចេញពីlimitទី១
10
ក្នុងករណីអ្នកបានធ្វើតេស្តUniformity of weight ចំនួន២០គ្រាប់ មាន១គ្រាប់ធ្លាក់ចេញពី Limitទី២។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test uniformity of weight
11
ក្នុងករណីអ្នកបានធ្វើតេស្តUniformity of weight ចំនួន២០គ្រាប់ មាន៣គ្រាប់ធ្លាក់ចេញពី Limitទី១។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test uniformity of weight
12
តើការធ្វើតេស្តDisintegration ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាណប៉ុន្មាន?
- 35 C - 39 C
13
តើការធ្វើតេស្តDissolution ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាណប៉ុន្មាន?
- 37 C ± 0.5 C
14
នៅពេលធ្វើតេស្ត Disintegration តើអ្នកសង្កេតមើលរបៀបមិច ទើបកត់យកនាទីជាលទ្ធផល?
គ្រាប់ថ្នាំបំបែក និងធ្លាក់អស់ពីកញ្ជ្រែង
15
ក្នុងករណីអ្នកបានធ្វើតេស្តDisintegration ចំនួន៦គ្រាប់ មាន១គ្រាប់ធ្លាក់ចេញពីLimit acceptable ។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ត្រូវធ្វើថែម១២គ្រាប់ទៀតអោយគ្រប់១៨គ្រាប់ បើមានធ្លាក់ត្រឹម២គ្រាប់ ក្នុងចំណោម១៨គ្រាប់ សន្និដ្ឋានថាជាប់
16
ក្នុងករណីអ្នកបានធ្វើតេស្តDisintegration ចំនួន៦គ្រាប់ មាន៣គ្រាប់ធ្លាក់ចេញពីLimit acceptable ។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test disintegration
17
តើយើងកំណត់ ចំនួននាទីនិងជុំ ទៅលើឧបករណ៍Friability tester ដូចម្តេចមុនពេលចាប់ផ្តើមដំណើរការ?
២៥ជុំ/១នាទី រយៈពេល៤នាទី
18
តើយើងត្រូវយកថ្នាំប៉ុន្មានគ្រាប់ទៅធ្វើតេស្តFriability?សូមបញ្ជាក់
- Mass > 650mg take 10 tablets if Mass < 650mg weight around 6.5g
19
តើនៅពេលណាទើបយើងអោយលទ្ធផលជាប់តេស្ត Friability?
មានភាពសំណឹកទាបជាង១%
20
ក្នុងករណីយើងតេស្តFriability ពេលឧបករណ៍ដំណើរការចប់ មានថ្នាំ១គ្រាប់បែកជា២ តើយើងផ្តល់លទ្ធផលដូចម្តេច?
ធ្វើតេស្តចំនួន៣ដងដើម្បីបញ្ជាក់ បើមិនមានគ្រាប់ថ្នាំប្រេះបែកទៀតទេ ហើយF<1% ថ្នាំជាប់ Test friability
21
ដើម្បីរកភាគរយនៃភាពសុទ្ធ(Purity) របស់វត្ថុធាតុដើម យើងត្រូវធ្វើតេស្ត?
- Assay
22
Test Dissolution គឺធ្វើដើម្បី?
រកភាគរយនៃភាពរលាយរបស់សារធាតុសកម្មចូលក្នុសសៃឈាម
23
Test Disintegration គឺធ្វើដើម្បី?
រករយៈពេលនៃការបំបែករបស់ថ្នាំធៀបនៅក្នុងក្រពះ
24
In process control (Contrôle en cours de la fabrication) ធ្វើដើម្បី?
តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម ដើម្បីដំណើរការម៉ាសុីនផលិត
25
ដើម្បីវិភាគរកបរិមាណសារធាតុសកម្មឱសថ (Dosage/Assay) តើមានវិធីសាស្រ្ត (Method) អ្វីខ្លះ?
- Titration, Spectrophotometry, Chromatographie (HPLC)
26
What is Conformance to specification means?
- means that the drug substance and/or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.
27
Test microbiologique (qualité microbienne) des produits pharmaceutiques est un test qui ?
- permettent le dénombrement des bactéries mésophiles et des moisissures et levures et des microoganismes spécifiés capables de croitre en aérobiose.
28
Analytical method can be divided into two main types?
- Qualitative and Quantitative
29
Test uniformity of weight, the deviation of individual masses from the average mass less than 80 mg should not exceed the limits given below?
- ±10.0 minimum 18 and ±20.0 maximum 2
30
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?
- ±7.5 minimum 18 and ±15.0 maximum 2
31
Test uniformity of weight, the deviation of individual masses from the average mass more than 250 mg should not exceed the limits given below?
- ±5.0 minimum 18 and ±10.0 maximum 2
32
The requirements of the test disintegration are met if not less than 16 of the 18 dosage units tested have disintegrated for uncoated tablet?
15 minutes
33
The requirements of the test disintegration are met if not less than 16 of the 18 dosage units tested have disintegrated for coated tablet?
30 minutes
34
In the assay of paracetamol tablet, what are the solutions need to run in spectrophotometer?
- Standard and sample solution of paracetamol and Blank NaOH 0.01N
35
For identification of the unknown sample by spectrophotometry, what is the information we need from the measurement?
- The absorbance of standard and sample solution
36
What is the Concentration in C% (W/V) of 4g NaOH, 100ml?
4%
37
What is the Concentration in mol/L of 0.1g NaOH , 250ml?
0.01M
38
We prepare the indicator solution of potassium chromate (K2CrO4, MM = 194.19 g/mol) 5% (W/V) in 100ml of water, we weight mK2CrO4 ?
5g
39
The finished products containing active ingredients should comply with ................... composition of the marketing authorization.?
Both qualitative and quantitative
40
What is QC in pharmaceutical industrials?
- The laboratory testing to evaluate the quality of materials and the products after manufacturing
41
Which one of these is a physicochemical property of Drug substance (raw materials)?
- The solubility of substance
42
Which one of these is a physicochemical property of Drug product (finished product)?
- Disintegration time
43
Which form of drug formulation has disintegration time?
- Capsules and Tablets
44
Which one of these is a microbiological property of Drug product (finished product)?
- Total aerobic microbial count
45
Which one of these is a microbiological property of Drug product (finished product)?
- Total yeast and mold count
46
Which form of drug formulation need to evaluate for dissolution percentage?
- Capsules and Tablets
47
Which one is the correct sequence for drug absorption through the oral route?
- Disintegration –> Deaggregation –> Dissolution –> Absorption
48
Which form of drug formulation has pH in specification?
- Syrups
49
Which one of these is a physicochemical test of Drug substance (Raw materials)?
- Loss on drying
50
Which one of these is a physicochemical test of Drug product (finished product)?
- Friability
51
Which one of these is a physicochemical test of Drug product (finished product)?
- Hardness
52
Which one of these is a physicochemical test of Drug product (finished product)?
- Uniformity of weight or volume
53
Which of the following is not correct about High pressure liquid chromatography (HPLC)?
- There is no need to preparation of the samples
54
Which one of these is a physicochemical test of Drug substance (Raw materials)?
- Melting point
55
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Melting point
56
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Solubility of substance
57
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Loss on drying
58
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Hardness
59
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Uniformity ot weight or volume
60
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Friability
61
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Disintegration time
62
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Dissolution percentage
63
Which statement best describes a standard operating procedure (SOP)?
SOPs are a set of step-by-step instructions compiled by an organization to help workers carry out routine operations.
64
Why are standard operating procedures important?
To ensure consistent execution of key processes, efficiency, quality output and uniformity of performance, while reducing miscommunication.
65
When need calibration of glassware? Choose incorrect answer.
Indirect or calibration by comparison.
66
The methodology of calibration of glassware are? Choose incorrect answer.
Periodic of calibration of the glassware over the time of use
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?
Direct or absolute calibration
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?
Indirect or calibration by comparison
69
The parameters need to be validated for new analytical method development in order to identification of chemical compounds is?
Specificity
70
The parameters need to be validated for new analytical method development in order to testing for limit of impurities are?
Specificity and Detection Limit
71
The parameters need to be validated for new analytical method development in order to assay of chemical compounds are included, except?
Quantitation Limit
72
The ability of an analytical method to distinguish analyte from everything else that might be in the sample is the definition of?
Specificity
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?
Linearity
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?
Accuracy
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?
Precision
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?
Intermediate precision
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?
Repeatability
78
The ability of an analytical method is the lowest amount of analyte in a sample which can be detected, is the definition of?
Detection Limit
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?
Quantitation Limit
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?
Range
81
The range of concentration for analytical method validation is normally set between?
80%-120%
82
In the validation method for assay of paracetamol tablet by spectrophotometer at wavelength 257nm, the solution to be prepared are? Except
Balance solution