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80 Cards in this Set
- Front
- Back
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Used in cGMP Guidelines |
Pharmaceutical Inspection Cooperation Scheme (PICs) |
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IR Spectroscopy |
For functional group |
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UV-Vis Spectrophotometry |
Uses reference substance Testing of large molecules |
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Mass Spectrometry |
Used for volatile oil/gaseous materials |
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Other name of Cylinder plate method/ Plate Assay |
Kirby Bauer Test Disk Diffusion Test |
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VR of Heavy Metals + H2S TS |
Visie Result: Black |
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VR of Arsenic + Ag diethyldihiocarbamate |
Red complex |
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VR of Iron + NH4SCN TS |
Red complex |
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Chloride + AgNO3 TS |
White precipitate |
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VR of Sulfate + BaCl2 TS |
White precipitate (BaSO4) |
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Temperature at which water has a density of 1g/mL |
4C |
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USP Method for Specific Gravity |
Pycnometer |
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Standard/titrant for Karl Fischer Titrimety |
Na tartrate dihydrate (5mg water = 1 KFR) |
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Components of Karl Fischer Reagent |
SO2 Iodine Pyridine Anhydrous methanol |
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Types of Karl Fischer Regaent |
1A- Direct Titration 1B- Residual Titration 1C- Coulometric (auto-titrator) |
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Azeotropic Distillation |
Uses Toluene/Xylene Uses Toluene Moisture Apparatus |
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Temp in Drying of Organic |
105C |
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Temp in Drying Inorganic |
110-120C |
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Standard used in Powdered Glass Test |
H2SO4 VS Type I (less acid to be consumed) Type III (more acid to be consumed) |
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Intact inner surface of glass H2SO4 VS For type III |
Water Attack Test |
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Intact inner surface HCl VS Type I and III |
Surface glass test |
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New name for Powdered Glass Test |
Glass grain test (distinguishes typeI from type II and III) |
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Distinguishes Type I and II from Type III |
Surface Glass Test |
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Distinguishes type I and Type II |
Surface Etching Test |
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For Type I and II |
Arsenic Release Test |
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Official method for Particle Size Determination |
Sieve Analysis |
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Hardness tester that uses spring |
Stoke-Monsato |
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Hardness tester that uses air pump |
Strong-Cobb |
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Hardness tester that uses pliers |
Pfizer |
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Hardness tester that uses suspended weight |
Erweka |
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Most common type of hardness tester that uses motorized anvil |
Schleuniger |
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Hardness of Uncoated Compressed Tablet |
4-10kg |
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Hardness of buccal tablet |
8-10kg |
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Hardness of Chewable/Sublingual Tablet |
2-3kg |
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Apparatus used in Tablet Thickness |
Vernier Caliper |
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Tablet Weight |
Back (Definition) |
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Criteria for the assay of tablets |
90-110% |
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Apparatus used in Friability |
Roche Friabilator |
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Criteria for Friability |
No capping,chipping, cracking or obvious tablet breakage Precent friability is NMT 1% (old) and NMT 0.8% (new) |
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FPQC for Capsule |
Identification Assay Disintegration Dissolution Uniformity of Dosage |
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FPQC for Semisolid |
Identification Assay Determination of Consistency/Viscosity pH Spreadability Spatula Feel Melting Range Minimum Fill Metal Particles in ophthalmic ointment (NMT 50 particles) Microbial content |
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FPQC for Liquid dosage form |
Identification Assay Viscosity pH Deliverable Volume(10bottles for 30 mins) |
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FPQC of Suspension |
Sedimentation Volume Degree of Flocculation Ease of Redispersability Zeta Potential Particle Size Distribution |
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Deflocculated Suspension |
Small particle size Slower settling Low Sedimentation rate Prone to caking Better/Good appearance |
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Flocculated |
Large particle size Faster settling High sedimentation rate Easier to redisperse Poor appearance |
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Remedy for failed redispersability |
Add flocculating agent (NaCl, KCl) |
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Dilution Test |
Homogenous (o/w) Separation (w/o) |
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Dye solubility test |
With amaranth: red external (o/w) red internal (w/o)
With sudan-red: red internal (o/w) red external (w/o) |
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Conductivity Test |
Lights on- o/w Light off- w/o |
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Fluorescence Test |
UV light: Spotty: o/w Continuous: w/o |
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CoCl2 in Filter Paper Test |
Dry: blue ; Wet-pink Pink: o/w Blue: w/o |
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Uses 1% methylene blue in FPQC of Sterile Dosage Form |
Leaker’s Test |
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Visual inspection for the presence of particulate matter |
Clarity Test |
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Sterility Test |
Membrane Filtration- can filter the smallest organism for solutions Direct Inoculation- emulsion/suspension + nutrient= Incubation |
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Aerobic medium in Sterility Test |
Soybean Casein Digest Medium (B. subtilis and C. albicans) |
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Anaerobic medium for Direct Inoculation |
Fluid Thioglycollate Medium (Clostridium and Facultative anaerobe: P.aeruginosa and S. aureus) |
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Limulus amoebocyte lysate uses: |
Horseshoe crab (Limulus polygemus) |
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Climatic Zone I |
Temperate 21C / 45% RH |
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Climatic Zone II |
Mediterranean/Subtropical 25C/ 60% RH |
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Climatic Zone III |
Hot and Dry 30C / 35% RH |
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Climatic Zone IV A |
Hot and Humid 30C / 65% |
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Climatic Zone IV B |
Hot and Very Humid 30C / 75% RH |
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Long Term/Real Time Study |
RT: 30 (+-) 2 C and 75 (+-) 5% RH REF: 5 (+-) 3 C |
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Accelerated Study |
RT: 40 (+-) 2 C and 75 (+-) 5% RH Ref: 25 (+-) 2.5 C and 60 (+-) 5% RH |
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Total Aerobic Count |
Temp: 30-35 Duration: 2-3 days |
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Total Yeast and Molds |
Temp: 20-25 Duration: 5-7 days |
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Specific microorganism |
BAM- S. pyogenes (Topical/Oral) McConkey Agar- E.coli (Oral) Potato Dextrose Agar and Saboraud’s Dextrose Agar- Fungi (Topical/Oral) Lowenstein’s Jensen Agar- M. tuberculosis (Oral) |
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Ideal size for particle size management |
2 mcm |
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Particle size management for solution |
< 0.1 mcm |
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Particle Size management for colloidal |
0.1-1 mcm |
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Suspension particle size |
>1 mcm |
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Apparatus used in testing the viscosity |
Brookfield Viscometer |
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Formation of crystal |
Ostwald ripening |
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Steam and Ethylene Oxide Sterilization (Autoclave) |
Bacillus stearothermophilus |
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Dry heat sterilization |
Bacillus subtilis |
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Ionizing Radiation |
Bacillus pumilus |
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3 Techniques in Bacterial Endotoxins Test |
Gel- clot technique Photometric technique (Turbidimetric and chromogenic technique) |
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Determines particle size by means of SHADOW casted by particles |
Electronic particle counter (Nonspecific) |
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Collects particle size greater than the membrane pore size |
Membrane filtration technique (Disadvantage: Saturable) |
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Microbial assay of antibiotics |
Cylinder Plate Method Tubidimetric Method |
