問題一覧
1
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
2
តើការធ្វើតេស្តDissolution ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាណប៉ុន្មាន?
- 37 C ± 0.5 C
3
តើការធ្វើតេស្តDisintegration ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាណប៉ុន្មាន?
- 35 C - 39 C
4
The range of concentration for analytical method validation is normally set between?
80%-120%
5
The parameters need to be validated for new analytical method development in order to assay of chemical compounds are included, except?
Quantitation Limit
6
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
7
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Melting point
8
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
9
In process control (Contrôle en cours de la fabrication) ធ្វើដើម្បី?
តេស្តបឋម បញ្ជាក់ពីគុណភាពថ្នាំក្នុងផ្នែកផលិតកម្ម ដើម្បីដំណើរការម៉ាសុីនផលិត
10
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Hardness
11
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
12
Which one of these is a physicochemical test of Drug substance (Raw materials)?
- Loss on drying
13
The methodology of calibration of glassware are? Choose incorrect answer.
Periodic of calibration of the glassware over the time of use
14
Which one of these is a physicochemical property of Drug product (finished product)?
- Disintegration time
15
The parameters need to be validated for new analytical method development in order to testing for limit of impurities are?
Specificity and Detection Limit
16
La monographie est ?
- document qui est écrit des paramètres des tests et des spécifications des substances inscrits dans la pharmacopée
17
Which form of drug formulation has pH in specification?
- Syrups
18
Analytical method can be divided into two main types?
- Qualitative and Quantitative
19
Test Disintegration គឺធ្វើដើម្បី?
រករយៈពេលនៃការបំបែករបស់ថ្នាំធៀបនៅក្នុងក្រពះ
20
The parameters need to be validated for new analytical method development in order to identification of chemical compounds is?
Specificity
21
Which one is the correct sequence for drug absorption through the oral route?
- Disintegration –> Deaggregation –> Dissolution –> Absorption
22
What is QC in pharmaceutical industrials?
- The laboratory testing to evaluate the quality of materials and the products after manufacturing
23
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
24
What is the Concentration in mol/L of 0.1g NaOH , 250ml?
0.01M
25
The finished products containing active ingredients should comply with ................... composition of the marketing authorization.?
Both qualitative and quantitative
26
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Friability
27
Les paramètres doivent être écrit dans la monographie sont suivent, excepte ?
- Le fabricant
28
នៅពេលធ្វើតេស្ត Disintegration តើអ្នកសង្កេតមើលរបៀបមិច ទើបកត់យកនាទីជាលទ្ធផល?
គ្រាប់ថ្នាំបំបែក និងធ្លាក់អស់ពីកញ្ជ្រែង
29
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Dissolution percentage
30
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
31
Which one of these is a physicochemical test of Drug product (finished product)?
- Friability
32
La Module 3 du dossier CTD (ou ACTD) est décrit des informations concernent ?
La qualité
33
The ability of an analytical method to distinguish analyte from everything else that might be in the sample is the definition of?
Specificity
34
ក្នុងករណីយើងតេស្តFriability ពេលឧបករណ៍ដំណើរការចប់ មានថ្នាំ១គ្រាប់បែកជា២ តើយើងផ្តល់លទ្ធផលដូចម្តេច?
ធ្វើតេស្តចំនួន៣ដងដើម្បីបញ្ជាក់ បើមិនមានគ្រាប់ថ្នាំប្រេះបែកទៀតទេ ហើយF<1% ថ្នាំជាប់ Test friability
35
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.
36
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
37
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Loss on drying
38
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Uniformity ot weight or volume
39
តើនៅពេលណាទើបយើងអោយលទ្ធផលជាប់តេស្ត Friability?
មានភាពសំណឹកទាបជាង១%
40
Which one of these is a physicochemical property of Drug substance (raw materials)?
- The solubility of substance
41
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.
42
La référentiels de la qualité des matières premières peut trouver dans ?
- Les Pharmacopées
43
Which one of these is a physicochemical test of Drug substance (Raw materials)?
- Melting point
44
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
45
Which one of these physicochemical tests, is not test of Drug product (finished product)?
- Solubility of substance
46
For identification of the unknown sample by spectrophotometry, what is the information we need from the measurement?
- The absorbance of standard and sample solution
47
Which one of these is a microbiological property of Drug product (finished product)?
- Total yeast and mold count
48
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.
49
តើយើងកំណត់ ចំនួននាទីនិងជុំ ទៅលើឧបករណ៍Friability tester ដូចម្តេចមុនពេលចាប់ផ្តើមដំណើរការ?
២៥ជុំ/១នាទី រយៈពេល៤នាទី
50
Which one of these physicochemical tests, is not test of Drug substance (Raw materials)?
- Disintegration time
51
ដើម្បីវិភាគរកបរិមាណសារធាតុសកម្មឱសថ (Dosage/Assay) តើមានវិធីសាស្រ្ត (Method) អ្វីខ្លះ?
- Titration, Spectrophotometry, Chromatographie (HPLC)
52
តើការកំណត់Limit acceptableនៅក្នុងUniformity of weight គេកំណត់ឡើងដូចម្តេចខ្លះ ចំពោះទំរង់ឱសថនីមួយៗ?
ផ្អែកលើ Average Weight របស់ទំរង់ថ្នាំនីមួយៗ ដែលមានទំងន់ <80mg ឬនៅចន្លោះ 80mg- 250mg ឫ >250mg
53
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
54
Which one of these is a microbiological property of Drug product (finished product)?
- Total aerobic microbial count
55
Test Dissolution គឺធ្វើដើម្បី?
រកភាគរយនៃភាពរលាយរបស់សារធាតុសកម្មចូលក្នុសសៃឈាម
56
Which form of drug formulation need to evaluate for dissolution percentage?
- Capsules and Tablets
57
តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលធ្វើតេស្ត ធ្លាក់Uniformity of weight?
មានគ្រាប់ថ្នាំ2គ្រាប់ធ្លាក់ចេញពីlimitទី១ និងធ្លាក់ចេញពីlimitទី២ ឬ មាន៣គ្រាប់ធ្លាក់ចេញពីlimitទី១
58
ក្នុងករណីអ្នកបានធ្វើតេស្តUniformity of weight ចំនួន២០គ្រាប់ មាន៣គ្រាប់ធ្លាក់ចេញពី Limitទី១។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test uniformity of weight
59
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
60
ដើម្បីរកភាគរយនៃភាពសុទ្ធ(Purity) របស់វត្ថុធាតុដើម យើងត្រូវធ្វើតេស្ត?
- Assay
61
តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលធ្វើតេស្តជាប់Uniformity of weight?
ក្នុងគ្រាប់ថ្នាំ២០គ្រាប់ មាន១៨គ្រាប់យ៉ាងតិចជាប់ក្នុងlimit ទី១ និងមាន២គ្រាប់យ៉ាងច្រើន អាចធ្លាក់ចេញពីlimitទី១ ប៉ុន្តែមិនត្រូវធ្លាក់ចេញពីlimitទី២នោះទេ
62
Which form of drug formulation has disintegration time?
- Capsules and Tablets
63
Which one of these is a physicochemical test of Drug product (finished product)?
- Hardness
64
Which of the following is not correct about High pressure liquid chromatography (HPLC)?
- There is no need to preparation of the samples
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?
- ±10.0 minimum 18 and ±20.0 maximum 2
66
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
67
ក្នុងករណីអ្នកបានធ្វើតេស្តDisintegration ចំនួន៦គ្រាប់ មាន១គ្រាប់ធ្លាក់ចេញពីLimit acceptable ។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ត្រូវធ្វើថែម១២គ្រាប់ទៀតអោយគ្រប់១៨គ្រាប់ បើមានធ្លាក់ត្រឹម២គ្រាប់ ក្នុងចំណោម១៨គ្រាប់ សន្និដ្ឋានថាជាប់
68
ក្នុងករណីអ្នកបានធ្វើតេស្តUniformity of weight ចំនួន២០គ្រាប់ មាន១គ្រាប់ធ្លាក់ចេញពី Limitទី២។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test uniformity of weight
69
តើឱសថប្រភេទណាខ្លះតម្រូវអោយធ្វើតេស្តUniformity of weight? (រកចម្លើយខុស)
- Sirop
70
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
71
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
72
What is the Concentration in C% (W/V) of 4g NaOH, 100ml?
4%
73
តើយើងត្រូវយកថ្នាំប៉ុន្មានគ្រាប់ទៅធ្វើតេស្តFriability?សូមបញ្ជាក់
- Mass > 650mg take 10 tablets if Mass < 650mg weight around 6.5g
74
When need calibration of glassware? Choose incorrect answer.
Indirect or calibration by comparison.
75
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
76
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
77
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
78
Définition de la spécification ?
Liste d'analyses avec les références à des procédures analytiques et les critères d'acceptation appropriées
79
ក្នុងករណីអ្នកបានធ្វើតេស្តDisintegration ចំនួន៦គ្រាប់ មាន៣គ្រាប់ធ្លាក់ចេញពីLimit acceptable ។ តើអ្នកសន្និដ្ឋានដូចម្តេច?
ថ្នាំធ្លាក់test disintegration
80
In the validation method for assay of paracetamol tablet by spectrophotometer at wavelength 257nm, the solution to be prepared are? Except
Balance solution
81
Which one of these is a physicochemical test of Drug product (finished product)?
- Uniformity of weight or volume
82
Why are standard operating procedures important?
To ensure consistent execution of key processes, efficiency, quality output and uniformity of performance, while reducing miscommunication.