問題一覧
1
What are the two liquid dosage form
Sterile/Parenteral , Non-sterile
2
Refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient.
Dosage form.
3
Relate the drug activity to its route of administration.
Dosage forms
4
Whar are the classification of dosage forms
Route of administration , Physical properties , Release pattern
5
These are pharmaceutical formulations that contain a mixture of active drug components and nondrug components (excipients) dissolved or suspended in a suitable solvent or mixtures of solvents.
Liquid dosage form
6
These are pourable and designed to provide a rapid therapeutic effect
Liquid dosage form
7
What are test conducted in the Sterile/Parenteral Liquid Dosage Forms
Sterility , Test for pyrogen, Safety test, Particulate matter , Leakers test
8
Determination of the presence or absence of viable organisms
Sterility test
9
General chapter 71
Sterility test
10
test for effectiveness of the sterilization process.
Biological indicators.
11
Primary intended for the culture of anaerobic bacteria as well as aerobic bacteria.
Fluid thioglycolate medium.
12
Incubated for 14 days at 30-35 degrees Celsius
Fluid thioglycolate medium.
13
Suitable for the culture of both fungi and aerobic bacteria.
Soyabean casein digest medium.
14
Incubated for 14 days at 20-25 degrees Celsius
Soyabean casein digest medium.
15
Moist heat
Bacillus stearothermophilus
16
Dry heat
Bacillus subtilis
17
Ethylene oxide
Bacillus stearothermophilus
18
Radiation
B. subtilis, B. stearothermophilus, B. pumilus
19
What are methods for pyrogen testing
Bacterial Endotoxin Test (BET) , Pyrogen test
20
General Chapter <85>
Bacterial Endotoxin Test (BET)
21
Limulus Amebocyte Lysate from
Limulus polyphemus or Tachypleus tridentatus
22
What are the two methods for bacterial endotoxin test using LAL reagent
Gel clot formation , Turbidimetric method.
23
General Chapter <151>
Rabbit pyrogen test.
24
Involves the rise in temperature of healthy and mature rabbits following the IV injection of test solution
Rabbit pyrogen test
25
What is the dose required for rabbit pyrogen test
10 mL per kg, unless otherwise specified
26
Corticotrophin injection
Rat (either male or female)
27
COD liver oil
Rat (Rachitic)
28
Vasopressin injection
Rate (Male)
29
Chorionic gonadotropin
Rat (Female, 2-23 days old)
30
Digitalis
Pigeon
31
Oxytocin
Chicken
32
Parathyroid injection
Dog
33
Heparin and Protamine
Sheep blood plasma
34
Insulin, Metocurine & Tubocurarine injection
Rabbit
35
consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and to its heterogeneous composition.”
Particular matter
36
General chapter 788
Particular matter.
37
refers to the term for a mixture of solid particles and liquid droplets found in the air.
Particular matter.
38
What can be the possible effect of Particular matter.
Emboli , Granulomas, Potent Immunogenic effect
39
What are the stages test approach for particular matter
Light obscuration , Microscopic procedure
40
Light obscuration procedure
Electron Particle Counters
41
Microscopic procedur
Membrane Filtration
42
Light obscuration >10 for LVP
25 per ml.
43
Light obscuration >10 for SVP
6,000 per ml.
44
Light obscuration >25 for SVP
600 per ml
45
Light obscuration >25 for LVP
3 per ml
46
Microscopic method >25 for SVP
300 per ml
47
Microscopic method >10 for SVP
3,000 per ml
48
Microscopic method >25 for LVP
2 per ml.
49
Microscopic method >10 for LVP
12 per ml
50
Negative pressure within incompletely sealed ampule while submerged in dye solution
Leakers test
51
Rinse dye from the outside
Leakers test
52
What are types of ampule seal
Tip seal., Pull seal.
53
qualitative description of the dosage form (odor, color, taste, clarity – should remain clear under temperature: 4 to 47 degrees Celsius)
Solution.
54
pH, viscosity, optical activity, refractive index
Physicochemical test for solution.
55
What are the test for suspension
Sedimentation volume , Size particles , Re-dispersibility, Zeta potential , Rheological properties , Temperature and Gravitation Stress test
56
The ratio of the ultimate volume of sediment (Vu) to the original volume of sediment (Vo) before settling
Sedimentation volume.
57
Im size particle of suspension what is the ideal side.
2 micrometer.
58
The amount of force necessary to redisperse particles. The product is subject to shaking for a minimum of 10 spm
Re-dispersibility
59
Determines the repulsive forces between particles (stability)
Zeta potential.
60
test for crystal growth at 40 degrees Celsius
Temperature and gravitation stress test.
61
What are test for emulsion
Electrophoretic analysis , Particle size number analysis , Gravitational and temperature stress test , Test for creaming, cracking, phase separation, and phase inversion
62
Amaranth is positive in?
O/W
63
Sudan red is positive in
W/O
64
UV fluorescence test is positive in
W/O
65
Conductivity is positive in
O/W
66
Cobalt chloride test in W/O Yield in?
Blue
67
Cobalt chloride test in O/W Yield in?
Pink
68
Direction of creaming test in W/O Yield in?
Sedimentation
69
Direction of creaming test in O/W Yield in?
Creaming
70
Determine whether a product complies with compendial specifications for microbial quality and quantity
Microbial limit test
71
Non-aqueous preparations for oral use total aerobic microbial count
10³
72
Aqueous preparations for oral use for oral use total aerobic microbial count
10²
73
Non Aqueous preparations for oral use for oral use total yeast and mold
10²
74
Aqueous preparations for oral use for oral use total yeast and mold
10¹
75
Deliverable Volumes, General Chapter <698>
Miscellaneous test for liquid dosage form
76
Determines whether the product will deliver the dosage form as stated in the label.
Miscellaneous test for liquid dosage form