MEDICAL COLLEGES OF NORTHERN PHILIPPINES

Alimannao Hills, Peñablanca, Cagayan

_______________________________________________________________________________

COLLEGE OF PHARMACY

PHARM CHEM II - QUALITY CONTROL II: DRUG TESTING AND ASSAY

FINAL EXAMINATION
2ND Semester S.Y. 2018- 2019

NAME:______________________________________________ DATE:___________________________
YEAR AND SECTION:___________________________ _______ SCORE:__________________________

TEST I: MULTIPLE CHOICE

Directions: Write in the space provided the letter of the correct answer of the corresponding question. Write legibly and in capital
letters only.

_____1. A quality control procedure which is also called the “crushing strength”.
A. Friability C. Tablet hardness
B. Tablet thickness D. Weight variation
____2. It is the result/ adjustment of a tablet if it is too hard?
A. May not disintegrate in the required period of C. Will not withstand the handling
time. D. Can resist shipping, abrasion and transportation
B. May disintegrate earlier than the required period of
time
_____3. The crude method used in the test for the crushing strength of tablets.
A. Use the Stoke’s-Monsanto instrument C. Use a caliper
B. Use the Erweka tester D. Rule of thumb
_____4. It is a test which measures the time it takes a tablet to break up into small particles.
A. Dissolution test C. Disintegration test
B. Particulate test D. All of the above
_____5. It is a test which measures the time it takes a tablet to go into solution.
A. Dissolution test C. Disintegration test
B. Particulate test D. All of the above
_____6. Ensures that the relevant and necessary tests are intact and in fact carried out is the function of?
A. Quality Assurance Department C. Both A and B
B. Quality Control Department D. Neither A nor B
____7. It is the force required to break a chewable tablet using the Stokes-Monsanto Hardness tester.
A. 2-3 kg C. 4-10 kg
B. 8-10 kg D. 10 kg
____8. This is the force required to break a buccal tablet using the Stokes-Monsanto Hardness tester.
A. 2-3 kg C. 4-10 kg
B. 8-10 kg D. 10 kg
____9. The values obtained by this equipment is 1.6 times than the value obtained in the Stokes-Monsanto Hardness tester.
A. Erweka Hardness Tester C. Pfizer Hardness Tester
B. Schleuniger Hardness Tester D. Strong Cobb Hardness Tester
____10. The apparatus used in disintegration test.
A. Vessel with paddle accessory C. Both A and D
B. Basket-rack assembly D. Vessel with basket accessory
_____11. It is defined as “that state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining
on the screen of the test apparatus is a soft mass having no palpably firm core”.
A. Dissolution of tablets C. Dissolution test
B. Disintegration test D. Complete disintegration
_____12. The time required for a buccal tablet to achieve complete disintegration.
A. 30 minutes C. 3 minutes
B. 2 hours and 5 minutes D. 4 hours
____13. It is the time required for a sublingual tablet to achieve complete disintegration.
A. 30 minutes C. 3 minutes
B. 2 hours and 5 minutes D. 4 hours
____14. It is the time required for an enteric coated tablet to achieve complete disintegration.
A. 30 minutes C. 3 minutes
B. 2 hours and 5 minutes D. 4 hours
____15. How many additional tablets will undergo stage 2 if the batch failed the initial stage in tablet disintegration test?
A. 12 tablets
B. 6 tablets
C. 18 tablets
D. None of the above
____16. This department is staffed with scientist and technicians responsible for the sampling and analytical testing of incoming raw
materials and inspection of packaging components, including labeling.
A. Quality Assurance Department C. Both A and B
B. Quality Control Department D. Neither A nor
____17. This is a quality control process which provides early warnings of conditions that can lead to out of control situations.
A. Sampling and analytical testing C. Environmental monitoring
B. In-process testing D. Monitoring product quality
____18. The following are monitored in the environmental conditions during manufacturing except:
A. Air and water systems C. Levels of particulate
B. Microbial matter D. None of the above
____19. It is the analytical testing of products before release.
A. Final product testing C. Monitoring product quality
B. Inspection of operations for compliance D. In process testing
____20. The following are main areas of quality control except:
A. Raw materials quality control C. Analytical testing quality control
B. In process quality control D. Final process
____21. It is the test for the leaching potential of glass.
A. Durometer test C. Water attact test
B. Powdered glass test D. Identification test
____22. It is the test for the intact surface of glass.
A. Durometer test C. Water attact test
B. Powdered glass test A. Identification test
____23. In friability testing, the maximum weight loss allowed is?
A. 1% C. NMT 2%
B. NMT 5% D. 10%
____24. In friability testing, the specification for the test is?
A. 25 Revolutions C. 4 mins
B. 100 rotations D. All of the above
____25. How many tablets must be taken as sample in the friability testing if the tablet weighs less than 650 mg?
A. Sample equivalent to 6.5 g C. 10 whole tablets
B. 20 tablets and an extra sample of 1 D. None of the above
____26. How many tablets must be taken as sample in the friability testing if the tablet weighs 650 mg or greater?
A. Sample equivalent to 6.5 g C. 10 whole tablets
B. 20 tablets and an extra sample of 1 D. None of the above
____27. How many samples will you get for testing from a batch of large volume parenterals?
A. 10 containers C. 10% or 4 containers
B. 2% or 20 containers D. 20 containers
____28. The primary sterility test method.
A. Gel clot method C. LAL test
B. Direct inoculation method D. Membrane filtration technique
____29. The media used in primary sterility test method.
A. Soybean Casein Digest Medium C. Tryptone Soya Agar
B. Fluid Thioglycollate Medium D. Both A and B
____30. At what temperature is Fluid thioglycollate medium maintained?
A. 20-25 degree C C. 30-35 degree C
B. 25-30 degree C D. Room temperature
____31. At what temperature is Soybean Casein Digest Medium maintained?
A. 20-25 degree C C. 30-35 degree C
B. 25-30 degree C D. Room temperature
____32. What microorganisms are detected if we use the Fluid thioglycollate medium?
A. Anaerobic bacteria C. Aerobic bacteria
B. Fungi D. Both B and C
____33. What microorganisms are detected if we use the Soybean Casein Digest Media?
A. Anaerobic bacteria C. Aerobic bacteria
B. Fungi D. Both B and C
____34. The biological indicator used in dry heat sterilization.
A. Bacillus stearothermophilus C. Bacillus pumilus
B. Bacillus subtilis D. All of the above
____35. The biological indicator used in Ionizing radiation.
A. Bacillus stearothermophilus C. Bacillus pumilus
B. Bacillus subtilis A. All of the above
____36. How many samples must be taken for weight variation testing if the sample is a ordinary tablet?
A. 10 C. 6
B. 20 D. 18

____37. According to USP in the weight variation testing, what is the limit for tablets weighing 130mg or less?
 A. 5% C. 10%
B. 7.5% D. NMT 5%
____38. A stable product should retain how much amount of active ingredient?
A. 80% C. 90%
B. 85% D. 92%
____39. What is the minimum acceptable potency level?
A. 80% C. 90%
B. 85% D. 92%
____40. It is the time in which the preparation will remain stable when stored under a recommended storage condition.
A. Expiration date C. Best before date
B. Manufacturing date D. Both A and C
____41. It is a type of time-related stability failure.
A. Increase in therapeutic activity C. Increase in potency
B. Appearance of toxic substances D. Both A and C
____42. The following are errors in estimating expiration dates.
A. Alpha error C. Delta error
B. Gamma error D. All of the above
____43. Setting the expiration date too early.
A. Alpha error C. Type 2 error
B. Type 1 error D. Both A and B
____44. Setting the expiration date too late.
A. Alpha error C. Type 2 error
B. Type 1 error D. Both A and B
____45. According to USP in the weight variation testing, what is the limit for tablets weighing more than 324 mg?
A. 5% C. 10%
B. 7.5% D. NMT 5%
____46.What is the accepted limit for tablet thickness?
A. +15% C. +5%
B. +2.5% D. None of the above
____47. The following are importance of tablet thickness except:

A. Identical appearance C. Tablets will be suitable for packaging

B. Ease for swallowing D. None of the above
____48. The following are the common sources of weight variation, except?
A. Granulate density C. Inconsistent powder
B. Particle size distribution D. None of the above
____49. The following are dosage forms applicable to weight variation testing, except.
A. Hard capsules C. emulsions
B. Solutions for inhalation to be used in nebulizers D. film-coated tablet
____40. The medium used in the determination of total yeast and molds in the parenteral preparation.
A. Tryptone soya agar C. Potato dextrose agar
B. Blood agar media D. Saboraud’s dextrose agar

TEST II: MATCHING TYPE

Directions: Match the following Category of Column A to Column B. Write your answer in the space provided. Write
legibly and in capital letters only.
COLUMN A COLUMN B
_____1. Hardness test: Chewable tablet A. 4-10 kg
_____2. 30 to 40 degree Celsius B. 5%
_____3. Allowed difference in tablet thickness C. 8-10 kg
_____4. Friability: Maximum weight loss D. 2-3 kg
_____5. Weight variation: 130 mg or less E. 7.5%
_____6. Weight variation: 130 mg to 324 mg tab F. NMT 1%
_____7. Hardness test: Ordinary coated tablet G. 10%
_____8. Hardness test: Buccal tablet H. +5
_____9. 8 to 15 degree Celsius I. Cool
_____10. Any heat above 40 degree Celsius J. Cold
_____11. 2 to 8 degree Celsius K. Warm
_____12. Temperature not exceeding 8 degree Celsius L. Excessive heat
_____13. Temperature prevailing in a working area M. Room temperature
_____14. Weight variation: more than 324 mg tab N. Freezer
_____15. -25 to -10 degree Celsius O. Refrigerator
 TEST III: PROBLEM SOLVING
Directions: show your solution. Write legibly.

1. Determine the individual rise in the temperature of the test animals after administration of the product. What is your disposition?
Test Animal Initial Temperature Temperature after 1
hour
1 36.3 36.9
2 36.8 37.2
3 36.2 36.7

2. Compute for the % Label claim of the following samples. What is your disposition?
Test solution: Gastric juice TS Concentration of standard: 0.4 mg
Dilution factor: 2250 Label claim: 500 mg
Q: 90
Test Absorbance Weight
Animal
1 0.254 632
2 0.224 598
3 0.265 621
4 0.276 606
5 0.291 619
6 0.255 588
Standard 0.476 --

3. Compute for the average weight. Determine the Percentage limit. Compute for the minimum and maximum weight limit. Passed or
failed?
S1- 345.1 mg S8- 350.4 mg S15- 358.5 mg
S2- 336.3 mg S9- 357.3 mg S16- 374.2 mg
S3- 387.8 mg S10- 345.5 mg S17- 375.9 mg
S4- 356.9 mg S12- 309.7 mg S18- 389.2 mg
S5- 363.7 mg S11- 357.0 mg S19- 355.1 mg
S6- 343.5 mg S13- 30.6 mg S20- 396.3 mg
S7- 369.0 mg S14- 312.2 mg

Prepared by:

PEARLYN GRACE O. BANGAAN, RPh

Pharmacy Instructor