Contrôle Qualité Pharmaceutique Test

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?

Analytical method can be divided into two main types?

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

Which form of drug formulation has pH in specification?

តើឱសថប្រភេទណាខ្លះតម្រូវឱ្យធ្វើតេស្ត Uniformity of weight? (រកចម្លើយខុស)

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

តើយើងត្រូវយកថ្នាំប៉ុន្មានគ្រាប់ទៅធ្វើតេស្ត Friability? សូមបញ្ជាក់

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?

In process control (Contrôle en cours de la fabrication) ធ្វើដើម្បី?

Which form of drug formulation has disintegration time?

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

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

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

ក្នុងករណីអ្នកបានធ្វើតេស្ត​ Uniformity of weight ចំនួន២០គ្រាប់ មាន១គ្រាប់ធ្លាក់ចេញពី Limit ទី២។ តើអ្នកសន្និដ្ឋានដួចម្តេច?

Test Disintegration គឺធ្វើដើម្បី?

Why are standard operating procedures important?

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

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?

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

When need calibration of glassware? Choose incorrect answer.

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?

តើការធ្វើតេស្ត Disintegration ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាពប៉ុន្មាន?

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?

ក្នុងករណីអ្នកបានធ្វើតេស្ត Uniformity of weight ចំនួន២០គ្រាប់មាន៣គ្រាប់ធ្លាក់ចេញពី Limit ទី១។ តើអ្នកសន្និដ្ឋានដូចម្តេច?

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?

Test Dissolution គឺធ្វើដើម្បី?

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

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

La monographie est ?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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

What is Conformance to specification means?

នៅពេលធ្វើតេស្ត Disintegration តើអ្នកសង្កេតមើលរបៀបមិច ទើបកត់យកនាទីជាលទ្ធផល?

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?

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

តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលបានធ្វើតេស្ត ជាប់ Uniformity of weight?

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

តើនៅពេលណាទើបអ្នកអាចសន្និដ្ឋានថាឱសថដែលបានធ្វើតេស្ត ធ្លាក់ Uniformity of weight?

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

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

ក្នុងករណីអ្នកបានធ្វើតេស្ត​ Disintegration ចំនួន 6 គ្រាប់ មាន៣គ្រាប់ធ្លាក់ចេញពី Limit acceptable។ តើអ្នកសន្និដ្ឋានដូចម្តេច?

តើការធ្វើតេស្ត Dissolution ត្រូវអនុវត្តន៍បាននៅសីតុណ្ហភាពប៉ុន្មាន?

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