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Compendial Requirements for Liquid Dosage Forms (small letters)

Total questions: 35

Worksheet time: 33mins

Name
Class
Date
1.

It refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient.

(a)  

2.

These tests are performed to ensure that products in the market are safe and effective at the time of use and the entire duration of their shelf life

(a)  

3.

These are pharmaceutical formulations which contain a mixture of active drug components and nondrug components dissolved or suspended in a suitable solvent or mixtures of solvents.

(a)  

4.

A test for the determination of the presence of viable organisms.

(a)  

5.

Biological indicator for moist heat sterilization technique.

(a)  

6.

Biological indicator for dry heat sterilization technique.

(a)  

7.

Biological indicator for ethylene oxide sterilization technique.

(a)  

8.

Components of LAL reagents

a)

Bacillus stearothermophilus

b)

Bacillus subtilis

c)

Limulus polyphemus

d)

Tachypleus tridentatus

e)

Tachypleus xiphosura

9.

Sample size of test animals in the first stage of the quantitative fever response test.

(a)  

10.

Sample size of test animals in the second stage of the quantitative fever response test.

(a)  

11.

Animal employed in Corticotrophin inj. safety test.

(a)  

12.

Animal employed in Vasopressin inj safety test.

(a)  

13.

Animal employed in Chorionic gonadotropin safety test.

(a)  

14.

Animal employed in Cod liver oil safety test.

(a)  

15.

A rat with deficiency of Vit. D

(a)  

16.

Animal employed in Glucagon safety test.

(a)  

17.

Animal employed in Oxytoxin safety test.

(a)  

18.

Animal employed in Parathyroid inj. safety test.

(a)  

19.

Animal employed in Digitalis safety test.

(a)  

20.

Animal employed in Insulin, Metocurine & Tubocurarine inj. safety test.

(a)  

21.

Animal employed in Heparin and Protamine safety test.

(a)  

22.

A test that determines integrity or presence in the leak of the containers.



(a)  

23.

Dye used in the leaker's test.

(a)  

24.

The phase inversion determination.

(a)  

25.

It determine whether a product complies with compendial specifications for microbial quality and quantity.

(a)  

26.

It determines whether the product will deliver the dosage form as stated in the label.

(a)  

27.

Ideal size of particles in μm.

(a)  

28.

It is the amount of the force necessary to redisperse particles, product is subject to shaking for minimum of 10 spm.

(a)  

29.

It determines the repulsive forces between particles.

(a)  

30.

True or False

Higher or closer to 1 sedimentation level = evenly distributed.

a)

True

b)

False

31.

Non-sterile LDF

a)

solutions

b)

suspension

c)

emulsions

d)

injections

e)

elixirs

32.

Sterile preparations

a)

STERILITY TEST

b)

PARTICULATE MATTER TEST

c)

LEAKER’S TEST

d)

TEST FOR PYROGENS

e)

MICROBIAL LIMIT TEST

33.

Methods in the test for pyrogens:

a)

Bacterial Endotoxin Test

b)

Pyrogen Test

c)

Microbial Limit Test

d)

Membrane Filtration

e)

Direct Inoculation

34.

Bacterial endotoxins are from cell wall of G (__)

a)

negative

b)

positive

35.

Two methods in BET.

a)

Gel-clot formation

b)

Direct Inoculation

c)

Membrane Filtration method

d)

Turbidimetric method

e)

Particulate Matter test