QC I & II Flashcards
Aa for Digoxin
Pigeon
Aa for Insulin
Rabbit π°
Aa for Tubocurarine
Rabbit π
Aa for Chorionic Gonadotropin
Female ratπ
Aa for Vasopressin
Male rat π
Aa for Oxytocin
Chicken π
Aa for Glucagon
Cat πΊ
Aa for Corticotropin injection
Rat π
Aa for Cod liver oil
Rat π
Aa for Parathyroid hormone
Dog πΆ
Aa for Heparin
Sheep π
Aa for Protamine
Sheep π
Turbidity/transmittance in microorganism π¦ π§«
580nm
Turbidity/transmittance in antibiotic π
530nm
Based on diameter of the ZOI.
Cylinder Plate/Plate Assay
Turbidimetric Method/Tube Assay
Cylinder Plate/Plate Assay
based on measurement of turbidity/transmittance
Cylinder Plate/Plate Assay
Turbidimetric Method/Tube Assay
Turbidimetric Method/Tube Assay
Pen G
S. aureus
Bacitracin
Micrococcus luteus
Streptomycin
Klebsiella pneumoniae
Chloramphenicol
E. coli
Vancomycin
B. subtilus
Niacin, Pantothenate
Lactobacillus plantarum
Cyanocobalamin
Lactobacillus leichmannii
Heavy metals
Formation of sulfides
Heavy metals
Formation of sulfides
H2S in TS
Black
ZnS
White
CdS
Yellow
MnS
Pink
SbS
Orange
Arsenic
Ag diethyl dithiocarbonate (red color)
Chloride
AgNO3 (White ppt of AgCl)
Sulfates
BaCl2 (white ppt of BaS04)
Iron
NH4SCn(blood red of Fe)
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?
Powder Glass Test
Type l & ll
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?
Water Attack Test
Type lI Glass only
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?
Surface Glass Test
Type I, Il, Ill
Initial Moisture Content limit?
0.5-1%
10-20%
25-30%
31-35%
31-35%
Adequacy of wetness limit?
0.5-1%
10-20%
25-30%
31-35%
0.5-1%
Dry sieving (for particles > 75 micrometer in diameter)
Airjet
Sonic sifting
Mechanical Sieving/Agitation
Mechanical Sieving/Agitation
for < 75 micrometer, single sieve at a time
Airjet
Sonic sifting
Mechanical Sieving/Agitation
Airjet
for <75 micrometer, nest of sieves
Airjet
Sonic sifting
Mechanical Sieving/Agitation
Sonic sifting
force required to break Compressed uncoated tab
4-10 kg
7-10 kg
2-3 kg
>10 kg
4-10 kg
force required to break Chewable Tablet
4-10 kg
7-10 kg
2-3 kg
>10 kg
2-3 kg
force required to break Buccal Tablet
4-10 kg
7-10 kg
2-3 kg
>10 kg
7-10 kg
force required to break MR tablets
4-10 kg
7-10 kg
2-3 kg
>10 kg
> 10 kg
Immediate release
30 mins H2O
Buccal Tabs
4hrs H2O
Sublingual Tabs
2-3mins H2O
Enteric Coated Tabs
5 mins H2O
1 hr simulated gastric/intestinal fluid
Apparatus I
Basket
Apparatus ll
Paddle
Apparatus lll
Reciprocating Cylinder
Apparatus lV
Flow through Cell
Apparatus V
Paddle over Disk
Apparatus Vl
Revolving Cylinder
Apparatus Vll
Reciprocating Holder
test for ampoules; Dye: 1% Methylene Blue
Leakerβs Test
examination for the presence of particulate matters
Clarity Test
ensures that the sterilization process done was successful.
Freedom from the presence of viable microorganism.
Sterility Test
anaerobic bacteria (Clostridium), Preudomonas, S. areus (Aerobic bac)
Fluid Thioglycollate Medium
aerobic bacteria & fungi, Bacillus subtlis, Candida albicans
Soybean Casein Digest Medium
qualitative biological test based on fever response of rabbits (inj. In ear vein), 10ml of sample/kg by injection.
Pyrogen Test
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.
Bacterial Endotoxin Test (BET/LAL Test)
refers to the extraneous, mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.
Particulate Test
21 C/45% RH
Temperate
30C/35% RH
(Middle East)
Hot and Dry
25C/60% RH
Mediterranean/Subtropical
30C/65-75% RH
(Philippines)
Hot and Humid
Testing: Extreme Conditions Storage
Min. Time Period: 6 months (0,3,6)
Accelerated Studies
Testing points: 0,3,6,9,12,18, 24, 36
Minimum Time Period: 12 months or 1 year
Normal or Long Term/ Real Time Studies
<1.0mg
Ultramicroanalysis
1.0-10.0mg
Microanalysis
10.0-100.0mg
Semimicro/meso
100mg- 1000mg or 1g
Macroanalysis
closeness of an actual value to the theoretical value.
Accuracy
closeness of two or more actual values.
Precision
Error due to uncontrollable variable. Affects precision
Random (Indeterminate) Error
Error that has definite & identifiable cause. Affects accuracy
Systematic (Determinate) Error
Error that occurs occasionally
Gross Error
proton is transformed from one molecule to another.
Protolysis
proton is transformed from one molecule to another identical molecule.
Autoprotolysis
ability of a substance to act as either an acid or base.
Amphoteric
Determination of volume of a solution of known concentration required to react with a given amount of substance to be analyzed.
Titration/Titrimetry/Volumetric
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
Gravimetric Analysis
techniques which require a distinct type of technique based on the properties and nature of the material being assayed.
Special Methods/Miscellaneous Methods
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.
Titrimetric Method
reagent of known concentration
Titrant/Vol. solution/ Standard Solution
sample being analyze (ERLENMEYER FLASK)
Titrand/Analyte/Active Constituent
a process of adding and measuring the volume of titrant used in the assay by means of a burette.
Titration
amount of substance (mg), chemically equivalent to 1 ml of standard solution.
Titer Value
process of repeating the entire procedure but omitting the analyte/sample.
Blank determination