問題一覧
1
Dirt or insoluble matter
gross impurities
2
2 tangents separated by the longest distance
feret
3
Chloramphenicol
e. coli
4
Silver diethyldithiocarbamate
arsenic
5
Regular periodic quality reviews of all registered drugs
product quality review
6
Fastest particle analysis. Use 25 g of sample
sieve analysis
7
Uses a cylinder or plate disc impregnated with sample, placed on solidified nutrient medium in a petri dish. Base on zone of inhibition
cylinder plate
8
Can be used for identification and determination of conentration of a component
physical test
9
For ionizing radiation
bacillus pumilus
10
Vg + interparticle spaces
bulk volume
11
Used in the exam. Easier
square root system
12
Measures volume to determine density (constant wt)
graduated cylinder
13
Most reliable particle size distribution analysis
optical microscopy
14
Most common (new)
ansi
15
Ammonium thiocyanate
iron
16
Based on the ditillation of water and toulene or xylene
azeotropic
17
Elucidates the intrinsic stability of the drug substance and identify the likely degradation products. Under more severe conditions
stress testing
18
The ratio of the density of a substance to that of a reference substance. Measured using pycnometer or mhor westphal balance
specific gravity
19
For dry heat and ethylene oxide
bacillus subtilis
20
Conducted under normal conditions
long term stability studies
21
Ratio of the velocity of light in air to the velocity of light in the substance. Measured using abbe refractometer
refractive index
22
Systematic process for the assessment, control, commnication, and review of risks to the quality of the product
quality risk management
23
Niacin (B3), Pantothenic acid (B5)
lactobacillus plantarum
24
Cobalamin
lactobacillus leichmanni
25
Hydrogen sulfide
heavy metals
26
Buccal
8-10 kg
27
Protects from extraneous solids and loss of article
well closed
28
Leaching
hydrolytic resistance
29
Distance that will bisect the particle into halves
martin
30
Most common (old). Uses master tables
military standard
31
Set of activities that ensures quality in products and is focused on identifying defects in the products produced. Identify and correct defects. Product oriented
quality control
32
Conventional and ordinary coated tablet
4-10kg
33
For colored containers
light transmission
34
A set of activities that ensures qualiy in the process by which the products are developed. Prevent defects. Process oriented
quality assurance
35
May cause death or serious adverse health consequence
class 1
36
Applicable for liquid product nmt 250ml
deliverable volume
37
Diameter of the circle that will enclosed the particle
projected area of the circle
38
SL and chewable
2-3 kg
39
Contains important information about the properties of a particular hazardous substance. How to safely handle store, and dispose it.
material safety data sheet
40
Measure weight to determine density (constant volume)
scott volumeter
41
For semisolids with labeled content of nmt 150mg or 150ml
minimum fill
42
Bacitracin
micrococcus leteus
43
Silver nitrate
chloride
44
Solids, liquids, and vapors; loss of article, moisture
tight
45
Reflects the quality attributess of medicines
monograph
46
Streptomyin
klebsiella pneumoniae
47
Component of karl fischer titrimetry, except:
ethanol
48
Barium chloride
sulfate
49
For type 1 and 2 glass container. Limit: NMT 0.1 mcg/g
arsenic
50
Based on loss on drying at 110-120 for inorganic materials and 105 for organic materials
gravimetry
51
Test for glass except
soda lime
52
Used to measure tablet thickness
micrometer/vernier caliper
53
Impervious to air
hermetic
54
Vp + intraparticle spaces
granule volume
55
Uses test tubed filled with fluid nutrient medium. Test organism is inoculated. Transmittance
turbidimetric method
56
Determines tablet durability. Uses roche or vanderkaamp
friability
57
For steam / moist heat method
bacillus stearothermophilus
58
Date beyod which product loses stability
expiration date
59
Microorganisms
biological impurities
60
Period of time during which a product is expected to remain within specification
shelf life
61
Measure of its abiityy to rotate an incident plane of polaized light. Polarimeter
optical rotation
62
Totality features or conformance t specifications of a product
quality
63
Vancomycin
bacillus subtili
64
Eectent to which a product remains stable and within specifications
stability