QC I & II Flashcards

1
Q

Aa for Digoxin

A

Pigeon

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2
Q

Aa for Insulin

A

Rabbit 🐰

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3
Q

Aa for Tubocurarine

A

Rabbit πŸ‡

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4
Q

Aa for Chorionic Gonadotropin

A

Female rat🐁

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5
Q

Aa for Vasopressin

A

Male rat πŸ€

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6
Q

Aa for Oxytocin

A

Chicken πŸ”

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7
Q

Aa for Glucagon

A

Cat 😺

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8
Q

Aa for Corticotropin injection

A

Rat 🐁

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9
Q

Aa for Cod liver oil

A

Rat πŸ€

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10
Q

Aa for Parathyroid hormone

A

Dog 🐢

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11
Q

Aa for Heparin

A

Sheep πŸ‘

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12
Q

Aa for Protamine

A

Sheep πŸ‘

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13
Q

Turbidity/transmittance in microorganism 🦠🧫

A

580nm

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14
Q

Turbidity/transmittance in antibiotic πŸ’Š

A

530nm

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15
Q

Based on diameter of the ZOI.

Cylinder Plate/Plate Assay
Turbidimetric Method/Tube Assay

A

Cylinder Plate/Plate Assay

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16
Q

based on measurement of turbidity/transmittance

Cylinder Plate/Plate Assay
Turbidimetric Method/Tube Assay

A

Turbidimetric Method/Tube Assay

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17
Q

Pen G

A

S. aureus

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18
Q

Bacitracin

A

Micrococcus luteus

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19
Q

Streptomycin

A

Klebsiella pneumoniae

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20
Q

Chloramphenicol

A

E. coli

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21
Q

Vancomycin

A

B. subtilus

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22
Q

Niacin, Pantothenate

A

Lactobacillus plantarum

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23
Q

Cyanocobalamin

A

Lactobacillus leichmannii

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24
Q

Heavy metals

A

Formation of sulfides

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25
Q

Heavy metals

A

Formation of sulfides

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26
Q

H2S in TS

A

Black

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27
Q

ZnS

A

White

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28
Q

CdS

A

Yellow

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29
Q

MnS

A

Pink

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30
Q

SbS

A

Orange

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31
Q

Arsenic

A

Ag diethyl dithiocarbonate (red color)

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32
Q

Chloride

A

AgNO3 (White ppt of AgCl)

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33
Q

Sulfates

A

BaCl2 (white ppt of BaS04)

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34
Q

Iron

A

NH4SCn(blood red of Fe)

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35
Q

Test for leaching property of crushed glass. Sulfuric Acid is used

Powder Glass Test
Water Attack Test
Surface Glass Test
Light Transmission Test
Arsenic Release Test

For what type of glass?

A

Powder Glass Test
Type l & ll

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36
Q

Test for leaching property of intact surface of containers. Sulfuric Acid is used

Powder Glass Test
Water Attack Test
Surface Glass Test
Light Transmission Test
Arsenic Release Test

For what type of glass?

A

Water Attack Test
Type lI Glass only

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37
Q

Determines hydrolytic resistance of inner surface of glass. HCI VS is used

Powder Glass Test
Water Attack Test
Surface Glass Test
Light Transmission Test
Arsenic Release Test

For what type of glass?

A

Surface Glass Test
Type I, Il, Ill

38
Q

Initial Moisture Content limit?

0.5-1%
10-20%
25-30%
31-35%

A

31-35%

39
Q

Adequacy of wetness limit?

0.5-1%
10-20%
25-30%
31-35%

A

0.5-1%

40
Q

Dry sieving (for particles > 75 micrometer in diameter)

Airjet
Sonic sifting
Mechanical Sieving/Agitation

A

Mechanical Sieving/Agitation

41
Q

for < 75 micrometer, single sieve at a time

Airjet
Sonic sifting
Mechanical Sieving/Agitation

A

Airjet

42
Q

for <75 micrometer, nest of sieves

Airjet
Sonic sifting
Mechanical Sieving/Agitation

A

Sonic sifting

43
Q

force required to break Compressed uncoated tab

4-10 kg
7-10 kg
2-3 kg
>10 kg

A

4-10 kg

44
Q

force required to break Chewable Tablet

4-10 kg
7-10 kg
2-3 kg
>10 kg

A

2-3 kg

45
Q

force required to break Buccal Tablet

4-10 kg
7-10 kg
2-3 kg
>10 kg

A

7-10 kg

46
Q

force required to break MR tablets

4-10 kg
7-10 kg
2-3 kg
>10 kg

A

> 10 kg

47
Q

Immediate release

A

30 mins H2O

48
Q

Buccal Tabs

A

4hrs H2O

49
Q

Sublingual Tabs

A

2-3mins H2O

50
Q

Enteric Coated Tabs

A

5 mins H2O
1 hr simulated gastric/intestinal fluid

51
Q

Apparatus I

A

Basket

52
Q

Apparatus ll

A

Paddle

53
Q

Apparatus lll

A

Reciprocating Cylinder

54
Q

Apparatus lV

A

Flow through Cell

55
Q

Apparatus V

A

Paddle over Disk

56
Q

Apparatus Vl

A

Revolving Cylinder

57
Q

Apparatus Vll

A

Reciprocating Holder

58
Q

test for ampoules; Dye: 1% Methylene Blue

A

Leaker’s Test

59
Q

examination for the presence of particulate matters

A

Clarity Test

60
Q

ensures that the sterilization process done was successful.
Freedom from the presence of viable microorganism.

A

Sterility Test

61
Q

anaerobic bacteria (Clostridium), Preudomonas, S. areus (Aerobic bac)

A

Fluid Thioglycollate Medium

62
Q

aerobic bacteria & fungi, Bacillus subtlis, Candida albicans

A

Soybean Casein Digest Medium

63
Q

qualitative biological test based on fever response of rabbits (inj. In ear vein), 10ml of sample/kg by injection.

A

Pyrogen Test

64
Q

measures the concentration of bacterial endotoxin that may be present in the sample using a lysate derived from the amoebocytes of the horsehoe crab, Limulus polyphemus.

A

Bacterial Endotoxin Test (BET/LAL Test)

65
Q

refers to the extraneous, mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.

A

Particulate Test

66
Q

21 C/45% RH

A

Temperate

67
Q

30C/35% RH
(Middle East)

A

Hot and Dry

68
Q

25C/60% RH

A

Mediterranean/Subtropical

69
Q

30C/65-75% RH
(Philippines)

A

Hot and Humid

70
Q

Testing: Extreme Conditions Storage
Min. Time Period: 6 months (0,3,6)

A

Accelerated Studies

71
Q

Testing points: 0,3,6,9,12,18, 24, 36
Minimum Time Period: 12 months or 1 year

A

Normal or Long Term/ Real Time Studies

72
Q

<1.0mg

A

Ultramicroanalysis

73
Q

1.0-10.0mg

A

Microanalysis

74
Q

10.0-100.0mg

A

Semimicro/meso

75
Q

100mg- 1000mg or 1g

A

Macroanalysis

76
Q

closeness of an actual value to the theoretical value.

A

Accuracy

77
Q

closeness of two or more actual values.

A

Precision

78
Q

Error due to uncontrollable variable. Affects precision

A

Random (Indeterminate) Error

79
Q

Error that has definite & identifiable cause. Affects accuracy

A

Systematic (Determinate) Error

80
Q

Error that occurs occasionally

A

Gross Error

81
Q

proton is transformed from one molecule to another.

A

Protolysis

82
Q

proton is transformed from one molecule to another identical molecule.

A

Autoprotolysis

83
Q

ability of a substance to act as either an acid or base.

A

Amphoteric

84
Q

Determination of volume of a solution of known concentration required to react with a given amount of substance to be analyzed.

A

Titration/Titrimetry/Volumetric

85
Q

separation by extraction, precipitation or other means of the constituent to be determined either in the natural state or in a form of a definite compound, the composition of which is known to the analyst ,and the weighing of the resulting product.
Used in the test for natural products or crude drugs

A

Gravimetric Analysis

86
Q

techniques which require a distinct type of technique based on the properties and nature of the material being assayed.

A

Special Methods/Miscellaneous Methods

87
Q

method in which the volume of a solution of known concentration consumed during analysis is taken as a measure of the amount of active constituent in a sample being analyzed.

A

Titrimetric Method

88
Q

reagent of known concentration

A

Titrant/Vol. solution/ Standard Solution

89
Q

sample being analyze (ERLENMEYER FLASK)

A

Titrand/Analyte/Active Constituent

90
Q

a process of adding and measuring the volume of titrant used in the assay by means of a burette.

A

Titration

91
Q

amount of substance (mg), chemically equivalent to 1 ml of standard solution.

A

Titer Value

92
Q

process of repeating the entire procedure but omitting the analyte/sample.

A

Blank determination