Unit 6

76問 • 1年前

問題一覧

What are the two liquid dosage form

Sterile/Parenteral, Non-sterile

Refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient.

Dosage form.

Relate the drug activity to its route of administration.

Dosage forms

Whar are the classification of dosage forms

Route of administration, Physical properties, Release pattern

These are pharmaceutical formulations that contain a mixture of active drug components and nondrug components (excipients) dissolved or suspended in a suitable solvent or mixtures of solvents.

Liquid dosage form

These are pourable and designed to provide a rapid therapeutic effect

Liquid dosage form

What are test conducted in the Sterile/Parenteral Liquid Dosage Forms

Sterility, Test for pyrogen, Safety test, Particulate matter, Leakers test

Determination of the presence or absence of viable organisms

Sterility test

General chapter 71

Sterility test

test for effectiveness of the sterilization process.

Biological indicators.

Primary intended for the culture of anaerobic bacteria as well as aerobic bacteria.

Fluid thioglycolate medium.

Incubated for 14 days at 30-35 degrees Celsius

Fluid thioglycolate medium.

Suitable for the culture of both fungi and aerobic bacteria.

Soyabean casein digest medium.

Incubated for 14 days at 20-25 degrees Celsius

Soyabean casein digest medium.

Moist heat

Bacillus stearothermophilus

Dry heat

Bacillus subtilis

Ethylene oxide

Bacillus stearothermophilus

Radiation

B. subtilis, B. stearothermophilus, B. pumilus

What are methods for pyrogen testing

Bacterial Endotoxin Test (BET), Pyrogen test

General Chapter <85>

Bacterial Endotoxin Test (BET)

Limulus Amebocyte Lysate from

Limulus polyphemus or Tachypleus tridentatus

What are the two methods for bacterial endotoxin test using LAL reagent

Gel clot formation, Turbidimetric method.

General Chapter <151>

Rabbit pyrogen test.

Involves the rise in temperature of healthy and mature rabbits following the IV injection of test solution

Rabbit pyrogen test

What is the dose required for rabbit pyrogen test

10 mL per kg, unless otherwise specified

Corticotrophin injection

Rat (either male or female)

COD liver oil

Rat (Rachitic)

Vasopressin injection

Rate (Male)

Chorionic gonadotropin

Rat (Female, 2-23 days old)

Digitalis

Pigeon

Oxytocin

Chicken

Parathyroid injection

Dog

Heparin and Protamine

Sheep blood plasma

Insulin, Metocurine & Tubocurarine injection

Rabbit

consists of mobile, randomly-sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis due to the small amount of material that it represents and to its heterogeneous composition.”

Particular matter

General chapter 788

Particular matter.

refers to the term for a mixture of solid particles and liquid droplets found in the air.

Particular matter.

What can be the possible effect of Particular matter.

Emboli, Granulomas, Potent Immunogenic effect

What are the stages test approach for particular matter

Light obscuration, Microscopic procedure

Light obscuration procedure

Electron Particle Counters

Microscopic procedur

Membrane Filtration

Light obscuration >10 for LVP

25 per ml.

Light obscuration >10 for SVP

6,000 per ml.

Light obscuration >25 for SVP

600 per ml

Light obscuration >25 for LVP

3 per ml

Microscopic method >25 for SVP

300 per ml

Microscopic method >10 for SVP

3,000 per ml

Microscopic method >25 for LVP

2 per ml.

Microscopic method >10 for LVP

12 per ml

Negative pressure within incompletely sealed ampule while submerged in dye solution

Leakers test

Rinse dye from the outside

Leakers test

What are types of ampule seal

Tip seal., Pull seal.

qualitative description of the dosage form (odor, color, taste, clarity – should remain clear under temperature: 4 to 47 degrees Celsius)

Solution.

pH, viscosity, optical activity, refractive index

Physicochemical test for solution.

What are the test for suspension

Sedimentation volume, Size particles, Re-dispersibility, Zeta potential, Rheological properties, Temperature and Gravitation Stress test

The ratio of the ultimate volume of sediment (Vu) to the original volume of sediment (Vo) before settling

Sedimentation volume.

Im size particle of suspension what is the ideal side.

2 micrometer.

The amount of force necessary to redisperse particles. The product is subject to shaking for a minimum of 10 spm

Re-dispersibility

Determines the repulsive forces between particles (stability)

Zeta potential.

test for crystal growth at 40 degrees Celsius

Temperature and gravitation stress test.

What are test for emulsion

Electrophoretic analysis, Particle size number analysis, Gravitational and temperature stress test, Test for creaming, cracking, phase separation, and phase inversion

Amaranth is positive in?

O/W

Sudan red is positive in

W/O

UV fluorescence test is positive in

W/O

Conductivity is positive in

O/W

Cobalt chloride test in W/O Yield in?

Blue

Cobalt chloride test in O/W Yield in?

Pink

Direction of creaming test in W/O Yield in?

Sedimentation

Direction of creaming test in O/W Yield in?

Creaming

Determine whether a product complies with compendial specifications for microbial quality and quantity

Microbial limit test

Non-aqueous preparations for oral use total aerobic microbial count

10³

Aqueous preparations for oral use for oral use total aerobic microbial count

10²

Non Aqueous preparations for oral use for oral use total yeast and mold

10²

Aqueous preparations for oral use for oral use total yeast and mold

10¹

Deliverable Volumes, General Chapter <698>

Miscellaneous test for liquid dosage form

Determines whether the product will deliver the dosage form as stated in the label.

Miscellaneous test for liquid dosage form

Cell structure.

Quinn Karylle Fuentes · 28問 · 2年前

Cell structure.