QA/QC (Chapter lll & IV) Flashcards
(91 cards)
1
Q
____ is the very common packaging material that is used in pharmaceutical products. Its basic structural network is made of _______. Other migratory oxides cause leaching and may hydrolyze to raise the pH of the solution and may catalyze or enter into a reaction.
A
Packaging;
Glass;
silicon oxide tetrahedron
2
Q
2 Problems with Container:
Container -> Drug
A
Leaching
3
Q
2 Problems with Container:
Drug -> Container
A
Sorption
4
Q
TYPES OF PACKAGING:
Direct contact w/ preparation
A
Primary
5
Q
TYPES OF PACKAGING:
Indirect (cartoon leaflets)
A
Secondary
6
Q
TYPES OF PACKAGING:
Contains 20° packaging (corrugated boxes)
A
Tertiary
7
Q
TYPES OF GLASS:
- Highly resistant borosilicate glass
A
TYPE I
8
Q
TYPES OF GLASS:
Chemically resistance; Low Leachability; Low thermal coefficient of expansion
A
TYPE I
9
Q
TYPES OF GLASS:
Treated soda lime
glass
A
TYPE II
10
Q
TYPES OF GLASS:
Soda lime glass
A
TYPE III
11
Q
TYPES OF GLASS:
Non-parenteral
A
IV
12
Q
TYPES OF GLASS:
- all products parenteral administration
A
TYPE I
13
Q
TYPES OF GLASS:
Silicon dioxide;
_______ - inert;
_______ -> increase resistance
A
TYPE I;
Boric oxide;
Sulfur dioxide
14
Q
TYPES OF GLASS:
- Acidic or neutral solutions
- Just Sulfur dioxide
A
TYPE II
15
Q
TYPES OF GLASS:
- Silicon dioxide
A
TYPE III
16
Q
Use:
* Crushed glass
* Titrated w/ H2SO4
* Limit’: ___ (Type l)
___ (Type III) 3-8
Type I, III
A
Old USP Tests;
Powdered Glass Test;
1mL type I;
8.5mL type lll
16
Q
Old USP Tests
A
HYDROLYTIC RESISTANCE (Leaching Property)
17
Q
Use:
* Intact
* Titrated w/ H2SO4
Type II
A
Old USP Tests;
Water Attack Test
18
Q
Use:
* Intact
* Titrated w/ HCI
Type I, III
A
Old USP Tests;
Surface Glass Test
19
Q
Use:
Type l from Type l & lll
A
New USP Tests;
Glass Grains Test
20
Q
Use:
Type l & ll from type lll
A
New USP Tests;
Surface Glass Test
21
Q
HYDROLYTIC RESISTANCE (Leaching)
A
New USP Tests
22
Q
Use:
Type l from ll
A
New USP Tests;
Surface Etching Test
23
Q
- For colored glass containers
- Limit: ________________ at any wavelength in the range of ________________
A
LIGHT TRANSMISSION;
NMT 10%;
290-250 nm (UV-VIS)
24
* For Type l or Type ll glass container
* Method: same with limit test for As (_____________)
* Limit:
ARSENIC;
Ag diethyldithiocarbamate TS;
NMT 0.1 mcg/g
25
Biological Reactivity Tests In Vivo:
Sample: Parenteral containers
Animal: Albino mice
Systemic Injection Test
26
Biological Reactivity Tests In Vivo:
Sample: Parenteral containers
Animal: Albino/White rabbit
Intracutaneous Test
27
Biological Reactivity Tests In Vivo:
Sample: Ophthalmic containers, medical devices
Animal: Albino rabbit
Eye Irritation Test
28
Biological Reactivity Tests In Vivo:
Sample: Material in direct contact with tissues
Animal: Rabbit
Implantation Test
28
Biological Reactivity Tests In Vitro:
Sample: Material (plastic)
Direct Contact Test
28
Biological Reactivity Tests In Vitro:
Sample: Elastomeric
Test Organism: Cell or Tissue
Agar Diffusion Test
29
What are the 3 Biological Reactivity Tests In Vitro?
Agar Diffusion Test
Direct Contact Test
Elution Test
30
Safety and toxicity test for infusion plastic sets is conducted using:
* A. Rabbits
* B. Dogs
* C. White mice
* D. Guinea pigs
C. White mice
31
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
32
Diameter measurement:
* ________ – 2 tangents represented by longest distance
Optical Microscopy;
Feret
32
Diameter measurement:
* ________ – bisect particles into halves
Optical Microscopy;
Martin
33
Diameter measurement:
* ________– circle diameter that will enclose the particle
Optical Microscopy;
Projected area of circle
34
PARTICLE SIZE DISTRIBUTION:
* Adv: Individual particles can be seen (most reliable)
* Disadv: 2D image only, very tedious
Optical Microscopy
35
PARTICLE SIZE DISTRIBUTION:
* Official, ideal
* Apparatus: set of sieves
* Adv: fastest, most efficient
* Limitation:
- Large particle size is needed (at least __ g)
- Not for ____ & ____ material
Sieving;
25g;
oily & cohesive
36
* # Of square opening per linear inch
* __ ___ # = __ particle size
Sieve/ Mesh No.;
increase sieve, decrease
37
Sieving Methods:
* Sieve shaker
* For particles > 75 μm
Mechanical agitation/ Dry Sieving
37
Sieving Methods:
* For particles < 75 μm
* Single sieve at a time
Air jet
38
Sieving Methods:
* For particles < 75 μm
* With vertically oscillating column of air (that lifts the specimen and then carries it back against mesh openings)
* Nest of sieves
Sonic sifting
39
* Weight difference of ____
* If __ % of total wt. is present on any sieve, the endpoint for that sieve is increase to wt. change of ___ %
* If __ % of the sample is (+) in a sieve, repeat test but insert a _______.
Endpoint for Sieving;
<5%;
<5%, ≤20%;
50%;
coarser sieve
40
Types of Granules:
Retained @ mesh 20
Coarse Granule
41
Types of Granules:
Passed @20, Retained @40
Good Granule
42
Types of Granules:
Passed @40
Fines
43
* Some fine powder is desired to fill the die cavity properly.
* _________ : Softness & Capping
* _________ : Decrease in tablet size during compression
* Correct particle size also ensures the proper dissolution of the drug.
Endpoint for Sieving;
Too much fines;
Not enough fines
44
Preferred Good Granules
85 - 90 %
45
Preferred Fine Granules
10 - 15 %
45
Bulk Density Method:
Graduated cylinder
Method I
46
Bulk Density Method:
Scott volumeter
Method Il
47
Bulk Density Method:
Vessel
Method Ill
48
Tapped Density Method:
Graduated cylinder
o 10 taps (V10)
o 500 taps (V500)
o 1250 taps (V1250)
Method I & II
49
Endpoint for Tapped Density (V500-V1250=?)
____ mL - V1250 = tapped volume
____ mL - Repeat 1250 taps (until difference is ≤2mL)
≤ 2mL;
> 2mL
50
Tapped Density Method:
Vessel
o ___ taps + 400 taps
Method lll;
200
51
* Measure of flowability
* Maximum angle possible between the surface of the pile of powder and the horizontal plane
* 3D angle assumes by a cone-like pile of material
Angle of Repose
52
* Flow rate (measured as mass per time flowing from any types of containers: cylinders, funnels, hoppers)
* For free-flowing powders only
Flow through orifice/ opening/ hole
53
Hausner’s Ratio FLOWABILITY:
0: 25-30°
Cl (%): ≤ 10
HR: 1.00-1.11
Notes: ______
Excellent;
Non-cohesive
54
Hausner’s Ratio FLOWABILITY:
0: 31-35°
Cl (%): 11-15
HR: 1.12-1.18
Notes: ________
Good;
Non-cohesive
55
Hausner’s Ratio FLOWABILITY:
0: 36-40°
Cl (%): 16-20
HR: 1.19-1.25
Notes: _______
Fair;
Cohesive
56
Hausner’s Ratio FLOWABILITY:
0: 41-45°
Cl (%): 21-25
HR: 1.26-1.34
Notes: ______
Passable;
Cohesive
57
Hausner’s Ratio FLOWABILITY:
0: 46-55°
Cl (%): 26-31
HR: 1.34-1.45
Notes: ______
Poor;
Cohesive
58
Hausner’s Ratio FLOWABILITY:
0: 56-65°
Cl (%): 32-37
HR: 1.46-1.59
Notes: ________
Very Poor;
Very Cohesive
59
Hausner’s Ratio FLOWABILITY:
0: ≥ 66°
Cl (%): >38
HR: > 1.60
Notes: ______
Very Very Poor;
Very Cohesive
60
Criteria: should contain _____ % API
Methods:
a. Coning and Quartering
b. Thief Sampling
c. % Purity
UNIFORMITY OF MIXTURES;
98-102% API
61
Sample: granules prior to compression
Criteria: NLT 0.5% to NMT 1% (0.5-1)
Methods:
1. Gravimetric Method
2. Ohaus Moisture Balance/Analyzer
MOISTURE CONTENT
62
MOISTURE CONTENT IMPLICATION:
Adhesion of granules to the die wall
Increase moisture;
Sticking
63
MOISTURE CONTENT IMPLICATION:
Adhesion of granules to the punch
Increase moisture;
Picking
64
MOISTURE CONTENT IMPLICATION:
Separation of small portions of the tablet
Decrease moisture;
Chipping
65
MOISTURE CONTENT IMPLICATION:
Complete/partial separation of the top or bottom part of the tablet
Decrease moisture;
Capping
66
MOISTURE CONTENT IMPLICATION:
Separation into two or more layers of the tablet
Decrease moisture;
Lamination
67
aka: Crushing Strength / Breaking Force
TABLET HARDNESS
68
* Ability to withstand mechanical shocks from handling in manufacturing, packaging and shipping
* ______________ : measures the mechanical integrity of the tablet. It is the breaking force required to cause them to fail.
* Affects disintegration and dissolution
* Adjustments:
o Too hard: may not disintegrate
o Too soft: may not be able to withstand handling
TABLET HARDNESS;
Breaking force
69
Used for:
Crude method
Rule of thumb
70
Used for:
Spring
Stokes-Monsanto
70
Used for:
Air pump, hydrolic pressure
Strong Cobb
71
Used for:
Suspended weight
Erweka
72
Used for:
Pliers
Pfizer
73
Used for:
Anvil, most commonly used, horizontal
Schleuniger/Heberlein
74
TABLET HARDNESS Acceptance Criteria:
4-10 kg
Ordinary compressed tablet
75
TABLET HARDNESS Acceptance Criteria:
7-10 kg
Buccal tablet
76
TABLET HARDNESS Acceptance Criteria:
2 - 3 kg
Chewable tablet,
Sublingual tablet
77
TABLET HARDNESS Acceptance Criteria:
10-20 kg
Sustained-release tablet
78
Importance:
o Identical appearance
o Facilitate packaging
o Accuracy for tablet counting machines
* Apparatus: _______ caliper, & _____ caliper
* Acceptance Criteria: ______of the set standard thickness
TABLET THICKNESS;
Micrometer caliper, Vernier caliper;
± 5%
79
Measure of compressibility of powder flow
Carr’s Index
80
A sieve number #40 means
o A. 40% of the total sample will pass through the sieve
o B. There are 40 square openings in every linear inch of the sieve
o C. The sieve is 40 linear inches with square openings
o D. The sieve maximum capacity is 40grams per analysis
B. There are 40 square openings in every linear inch of the sieve
81
The official method of determination of particle size distribution as per USP is:
o A. Optical microscopy
o B. Sieve method
o C. A and B
o D. NOTA
B. Sieve method
82
The following statements about sieving are correct, except:
o A. Sieving is the fastest method of analyzing the particle size distribution of powders and granules.
o B. The number of linear openings per square cm is called the sieve or mesh number.
o C. At least 25g of sample is needed for this method.
o D. The endpoint in sieving is achieved when the weight on any sieve does not change by >5%.
B. The number of linear openings per square cm is called the sieve or mesh number.
91
92
Tapped Density Method l & ll
Graduated cylinder
