QA/QC (Chapter ll) Flashcards
(101 cards)
1
Q
status of materials which are isolated physically while a decision is awaited on their release, rejection or reprocessing
A
Quarantine
2
Q
Materials that conform to tests are labeled with __________ color
A
Green
3
Q
All quarantine materials are labeled with __________ color
A
Yellow
4
Q
Materials that are rejected are labeled with __________ color
A
Red
5
Q
Stocks expiring first are used first
A
FEFO (First Expiry, First Out)
5
Q
Stocks brought in first are used first
A
FIFO (First In, First Out)
6
Q
WAREHOUSE DISTRIBUTION PRACTICES
A
FIFO, FEFO
7
Q
Chloride + AgNO3 TS → _____
A
Precipitation;
White ppt. (AgCl)
8
Q
Ammonium + NaOH TS → _____
A
Evolution of Gas;
Pungent odor/red to blue litmus paper
9
Q
Chemical Assay:
Volume
A
Titrimetry
10
Q
Chemical Assay:
Weight or Mass
A
Gravimetry
11
Q
Living system
A
Biologic Assay
12
Q
2 Biologic Assay
A
- Animal Assay
- Microorganism Assay
13
Q
ANIMAL USED:
Rabbit
Head drop assay
A
Tubocurarine
TubocuRabbit
14
Q
ANIMAL USED:
Pigeon
A
Digitalis
PigItalis
15
Q
Starch + I2 in KI TS → __________
A
Color Reaction;
Deep Blue Color
16
Q
ANIMAL USED:
Rabbit
A
Insulin
RabbInsulin
17
Q
ANIMAL USED:
Cat
A
Glucagon
GluCatgon
18
Q
ANIMAL USED:
Rat
A
Corticotropin
19
Q
ANIMAL USED:
Rachitic rat (Vit. ___ deficiency)
A
Cod Liver Oil;
D
20
Q
ANIMAL USED:
Female rat
A
Chorionic Gonadotropin
21
Q
ANIMAL USED:
Male rat
A
Vasopressin/ADH
22
Q
ANIMAL USED:
Chicken
A
Oxytocin
ManoXytocin, OxytoChicken
23
Q
ANIMAL USED:
Dog
A
Parathyroid Hormone
ParaDog
24
ANIMAL USED:
Sheep
Heparin and Protamine Sulfate
**SheEparin
25
BIOLOGICAL ASSAY:
Compedial Article
Insulin
26
BIOLOGICAL ASSAY:
Animal Employed
Rabbit
26
BIOLOGICAL ASSAY:
Activity Assayed
Hypoglycemic
27
BIOLOGICAL ASSAY:
Route of Administration for Animals
SC injection
28
BIOLOGICAL ASSAY:
Endpoint of Assay
Reduction of blood glucose level
28
BIOLOGICAL ASSAY:
Each mg has a biological potency of ___ USP insulin units
Unitage;
NLT 26.5 USP insulin units
29
BIOLOGICAL ASSAY:
Additional Biological Testing Required
Bacterial endotoxins
30
o Uses cylinders or paper discs on top of the solidified nutrient medium in a petri dish
o Based on diameter of the _______________.
Cylinder Plate Method;
Zone of Inhibition (ZOI)
30
o Uses a test tube filled with fluid
nutrient medium, where the test
organism is inoculated
o Based on transmittance of light
Turbidimetric Method
31
Based on transmittance of light:
Decrease potent
Increase turbid
32
Based on transmittance of light:
Increase transmittance = potent
Less turbid
33
Test Organism of (Antibiotic):
Penicillin G
Staphylococcus aureus (majority of antibiotics)
**Pen Staph**
34
Test Organism of (Antibiotic):
Bacitracin
Micrococcus luteus
**BaMi**
34
Test Organism of (Antibiotic):
Streptomycin
Klebsiella pneumoniae
**StrepKleb**
35
Test Organism of (Antibiotic):
Chloramphenicol
Escherichia coli
**ChlorEsch**
36
Test Organism of (Antibiotic):
Vancomycin
Bacillus subtilis
**VaBa/Vacillio**
37
Test Organism of (Antibiotic):
Nystatin, Amphotericin B
Saccharomyces cerevisiae
**Nice i-suck**
38
Test Organism of (Vitamin):
Niacin B3
Lactobacillus plantanum
39
Test Organism of (Vitamin):
Ca pantothenate B5
Lactobacillus plantanum
40
Test Organism of (Vitamin):
Cyanocobalamin B12
Lactobacillus leichmannii
41
Measures small amounts of impurities in a RM
LIMIT TEST
42
Types of Impurities:
Dirt or Insoluble matter
Gross
43
Types of Impurities:
Microorganisms
Biological
44
Types of Impurities:
byproduct, heavy metals, degradation products, reagents, catalysts, ligands, residual solvents
Chemical
45
LIMIT TEST Reagent used for:
Heavy Metals
Hydrogen sulfide TS (Black)
45
LIMIT TEST Reagent used for:
Chloride
Silver Nitrate TS (White ppt.)
45
LIMIT TEST Reagent used for:
Arsenic
Silver diethyldithiocarbamate TS
**Sili sa arse = die (red)
46
LIMIT TEST Reagent used for:
Iron
Ammonium thiocyanate TS
**Iro=Ammo (Red)
47
LIMIT TEST Reagent used for:
Sulfate
Barium chloride TS
48
LIMIT TEST Reagent used for:
Lead
Ammonia-cyanide solution TS, Thioacetamide TS
49
LIMIT TEST Reagent used for:
Ca, Na, CI
Flame photometry
**NaCaClose**
50
PHYSICAL TESTS method for instrument:
Pycnometer (official),
Mohr-West Phal Balance
Specific gravity
51
PHYSICAL TESTS method for instrument:
Dissolution in a suitable solvent
Solubility tests
52
PHYSICAL TESTS method for instrument:
Abbe refractometer
Refractive index
53
PHYSICAL TESTS method for instrument:
Polarimeter
Optical activity
54
PHYSICAL TESTS method for instrument:
Glass electrode pH meter
pH
55
PHYSICAL TESTS method for instrument:
Capillary tube
Melting point
56
* Ratio of density of substance to that of a reference substance at 25 °C
* pH2O = ____
* Pycnometer or Mohr-Westphal Balance
* Alcohol only: measure using a ____________ at 15.56 °C (60 °F)
Specific Gravity;
1g/ml at 4 °C;
hydrometer
57
* Ratio of velocity of light in ______ to the velocity of light in the substance at 25°C
* Represented by the formula:
* Where: i = angle of incident ray
* r = angle of refracted ray
* Measured using Abbe refractometer
Refractive index (n);
air;
58
angle of incident ray
i
59
angle of refracted ray
r
60
* Measure of ability to rotate an incident plane of polarized light
* May be ________________ or ________________
* Measured using ________________
Optical Rotation/Optical Activity;
dextrorotatory; levorotatory;
polarimeter
61
Optical Rotation:
Right, clock wise
dextrorotatory
62
Optical Rotation:
Left, Counter Clock Wise
Levorotatory
63
Solubility:
<1
Very Soluble
64
Solubility:
1 - 10
Freely Soluble
65
Solubility:
10 - 30
Soluble
66
Solubility:
30 - 100
Sparingly Soluble
66
Solubility:
100 - 1000
Slightly Soluble
67
Solubility:
1000 - 10,000
Very Slightly Soluble
68
Solubility:
>10,000
Insoluble
69
Indicates presence of impurities
Boiling Point/Melting Point (BP-MP)
70
Determines the amount of volatile matter driven off after drying
Loss on Drying (LOD)
70
In cases wherein H2O is the only volatile constituent
Water Content Determination/Aquametry
71
What type of method is Titrimetric/ Karl-Fischer Titrimetry
Method I
71
Official Methods of Water Determination
TAG/KAG
72
Standard Method for Physical tests:
KFR Components:
1. Sulfur dioxide
2. Iodine
3. Pyridine
4. Anhydrous
o Std: __________________
Method I: Titrimetric/ Karl-Fischer Titrimetry;
Sodium tartrate dihydrate
73
PHYSICAL TESTS (Titrimetric/ Karl-Fischer Titrimetry):
Types:
Method IB
Residual
74
PHYSICAL TESTS (Titrimetric/ Karl-Fischer Titrimetry):
Types:
Method IA
Direct
75
PHYSICAL TESTS
Types:
Method IC
Coulometric
75
o Based on distillation of Water with Toulene, Xylene, Benzene
o Uses a Toluene-moisture apparatus
Method II: Azeotropic
76
Physical Tests for method III
Temperature:
* Inorganic:
Method III: Gravimetric;
110-120 degree celsius
77
Physical Tests for method III
Temperature:
* organic:
Gravimetric;
105 degree celsius
78
Function:
Reacts with water to form sulfur trioxide
Sulfur dioxide
79
Function:
Prevents formation of pyridine- sulfur complex
Anhydrous methanol
80
Function:
Prevents reversal of action
Pyridine
81
Function:
Reacts with water to form hydroiodic acid
iodine
82
What is the solubility of a sample if 5 grams of it dissolves in 350 mL of water?
o A. Very soluble
o B. Sparingly soluble
o C. Practically insoluble
o D. Slightly soluble
B. Sparingly soluble
83
What microorganism is used in the microbial assay of Penicillin G?
o a. Ps. aeruginosa
o b. S. aureus
o c. E. coli
o d. B. subtilis
b. S. aureus
84
Which of the following laboratory apparatuses may be employed in the determination of specific gravity?
I. Hydrometer
II. Pycnometer
III. Mohr-Westphal Balance
o A. I, II
o B. II, III
o C. I, II, III
o D. I, III
C. I, II, III
85
What is the official instrument used for specific gravity
Pycnometer
86
Unit less
Specific gravity
87
What is the non-official instrument used for specific gravity
Mohr-Westphal Balance
88
angle of incident ray
i
89
angle of refracted ray
r
90
Based on loss on drying
Method III: Gravimetric / Drying or thermal method
