COMPENDIAL REQUIREMENTS FOR LIQUID DOSAGE FORMS

Question 1

What are the general (universal) tests of pharmaceutical products?

Answer 1

Assay
Identification test
Water content determination
Packaging test
Limit test

Question 2

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

Answer 2

DOSAGE FORM

Question 3

identification test, organoleptic test, physical and chemical test, limit test, packaging

Answer 3

Qualitative test

Question 4

limit test, assay, water content determination

Answer 4

Quantitative test

Question 5

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

Answer 5

Liquid Dosage Forms

Question 6

STERILE/PARENTERALS

Answer 6

1. STERILITY TEST
2. TEST FOR PYROGENS
3. SAFETY TEST
4. PARTICULATE MATTER TEST
5. LEAKER’S TEST

Question 7

determination of the presence of viable organisms

Answer 7

STERILITY TEST

Question 8

Methods of sterility test:

Answer 8

Primary – membrane filtration
Direct transfer – Direct Inoculation

Question 9

Test for effectiveness of sterilization process

Answer 9

Biological indicators

Question 10

Moist heat

Answer 10

Bacillus stearothermophilus

Question 11

Dry Heat

Answer 11

Bacillus subtilis

Question 12

Ethylene oxide

Answer 12

Bacillus stearothermophilus

Question 13

Radiation

Answer 13

B. pumilus
B. tearothermophilus
B. subtilis

Question 14

are fever causing substances

Answer 14

pyrogens

Question 15

Methods of test for pyrogens

Answer 15

Bacterial Endotoxin test (BET)
Pyrogen Test

Question 16

• is derived from the horseshoe crab
• limulus amebocyte lysate from Limulus polyphemus or Tachypleus tridentatus

Answer 16

LAL reagent

Question 17

Two Methods

Answer 17

Gel-clot formation
turbidimetric method

Question 18

need standard endotoxin and series of dilution of known concentration of standard endotoxin

Answer 18

Gel-clot formation and turbidimetric method

Question 19

quantitative fever response test

Answer 19

Rabbit Pyrogen Test

Question 20

Light Obscuration Particle Count Test → Electronic particle counters

Answer 20

PARTICULATE MATTER

Question 21

Advantages of PARTICULATE MATTER:

Answer 21

constant in-process measurement
quickly identify, size and count the particles
provides trend analysis to identify the problem

Question 22

Disadvantage of particulate matter:

Answer 22

requires routine preventive maintenance and calibration

Question 23

à Membrane filtration

Answer 23

microscopic Particle Count Test

Question 24

Advantages of Microscopic Particle Count Test:

Answer 24

allows collection of the particles larger than rated pore size
microscopic identification of particle types and materials

Question 25

Disadvantages of Microscopic Particle Count Test:

Answer 25

slow counting and sizing on membrane surface requires top and bottom lighting to distinguish all particle

Question 26

determine the integrity of the seal Negative pressure within incompletely sealed ampule while submerged in dye solution Rinse dye from outside

Answer 26

LEAKER’S TEST

Question 27

dye of leakers test

Answer 27

1% Methylene Blue

Question 28

Types of Ampule seal

Answer 28

Tip seal Pull Seal

Question 29

submerge the pressurized part in water and look for bubbles, which indicate a leak.

Answer 29

Tip seal

Question 30

a sealed container or package is placed in a vacuum chamber, and a vacuum is applied to simulate real-world conditions and identify any leaks or seal failures.

Answer 30

Pull Seal