問題一覧
1
General chapter 788
Particular matter.
2
Conductivity is positive in
O/W
3
test for crystal growth at 40 degrees Celsius
Temperature and gravitation stress test.
4
What are the stages test approach for particular matter
Light obscuration , Microscopic procedure
5
What is the dose required for rabbit pyrogen test
10 mL per kg, unless otherwise specified
6
Light obscuration >10 for SVP
6,000 per ml.
7
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
8
Oxytocin
Chicken
9
Determination of the presence or absence of viable organisms
Sterility test
10
Digitalis
Pigeon
11
Determines the repulsive forces between particles (stability)
Zeta potential.
12
What can be the possible effect of Particular matter.
Emboli , Granulomas, Potent Immunogenic effect
13
Corticotrophin injection
Rat (either male or female)
14
Determine whether a product complies with compendial specifications for microbial quality and quantity
Microbial limit test
15
Involves the rise in temperature of healthy and mature rabbits following the IV injection of test solution
Rabbit pyrogen test
16
Heparin and Protamine
Sheep blood plasma
17
qualitative description of the dosage form (odor, color, taste, clarity – should remain clear under temperature: 4 to 47 degrees Celsius)
Solution.
18
Light obscuration >25 for SVP
600 per ml
19
Microscopic method >25 for LVP
2 per ml.
20
Whar are the classification of dosage forms
Route of administration , Physical properties , Release pattern
21
The ratio of the ultimate volume of sediment (Vu) to the original volume of sediment (Vo) before settling
Sedimentation volume.
22
Radiation
B. subtilis, B. stearothermophilus, B. pumilus
23
What are methods for pyrogen testing
Bacterial Endotoxin Test (BET) , Pyrogen test
24
General Chapter <151>
Rabbit pyrogen test.
25
Moist heat
Bacillus stearothermophilus
26
Im size particle of suspension what is the ideal side.
2 micrometer.
27
COD liver oil
Rat (Rachitic)
28
Non-aqueous preparations for oral use total aerobic microbial count
10³
29
Sudan red is positive in
W/O
30
Incubated for 14 days at 20-25 degrees Celsius
Soyabean casein digest medium.
31
Insulin, Metocurine & Tubocurarine injection
Rabbit
32
What are types of ampule seal
Tip seal., Pull seal.
33
General chapter 71
Sterility test
34
Primary intended for the culture of anaerobic bacteria as well as aerobic bacteria.
Fluid thioglycolate medium.
35
Limulus Amebocyte Lysate from
Limulus polyphemus or Tachypleus tridentatus
36
Direction of creaming test in W/O Yield in?
Sedimentation
37
Cobalt chloride test in O/W Yield in?
Pink
38
test for effectiveness of the sterilization process.
Biological indicators.
39
Microscopic method >25 for SVP
300 per ml
40
These are pourable and designed to provide a rapid therapeutic effect
Liquid dosage form
41
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
42
Aqueous preparations for oral use for oral use total aerobic microbial count
10²
43
What are the two liquid dosage form
Sterile/Parenteral , Non-sterile
44
Rinse dye from the outside
Leakers test
45
What are the two methods for bacterial endotoxin test using LAL reagent
Gel clot formation , Turbidimetric method.
46
The amount of force necessary to redisperse particles. The product is subject to shaking for a minimum of 10 spm
Re-dispersibility
47
Light obscuration >25 for LVP
3 per ml
48
Vasopressin injection
Rate (Male)
49
Deliverable Volumes, General Chapter <698>
Miscellaneous test for liquid dosage form
50
Relate the drug activity to its route of administration.
Dosage forms
51
What are the test for suspension
Sedimentation volume , Size particles , Re-dispersibility, Zeta potential , Rheological properties , Temperature and Gravitation Stress test
52
Aqueous preparations for oral use for oral use total yeast and mold
10¹
53
Microscopic method >10 for LVP
12 per ml
54
What are test conducted in the Sterile/Parenteral Liquid Dosage Forms
Sterility , Test for pyrogen, Safety test, Particulate matter , Leakers test
55
Light obscuration >10 for LVP
25 per ml.
56
Cobalt chloride test in W/O Yield in?
Blue
57
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
58
Parathyroid injection
Dog
59
Refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient.
Dosage form.
60
UV fluorescence test is positive in
W/O
61
Direction of creaming test in O/W Yield in?
Creaming
62
Determines whether the product will deliver the dosage form as stated in the label.
Miscellaneous test for liquid dosage form
63
Microscopic procedur
Membrane Filtration
64
refers to the term for a mixture of solid particles and liquid droplets found in the air.
Particular matter.
65
Microscopic method >10 for SVP
3,000 per ml
66
Incubated for 14 days at 30-35 degrees Celsius
Fluid thioglycolate medium.
67
Non Aqueous preparations for oral use for oral use total yeast and mold
10²
68
Chorionic gonadotropin
Rat (Female, 2-23 days old)
69
Dry heat
Bacillus subtilis
70
General Chapter <85>
Bacterial Endotoxin Test (BET)
71
Suitable for the culture of both fungi and aerobic bacteria.
Soyabean casein digest medium.
72
pH, viscosity, optical activity, refractive index
Physicochemical test for solution.
73
Negative pressure within incompletely sealed ampule while submerged in dye solution
Leakers test
74
Amaranth is positive in?
O/W
75
Light obscuration procedure
Electron Particle Counters
76
Ethylene oxide
Bacillus stearothermophilus