relates the drugs activity to its route of administration

(a)  

• It includes both the mass of the dosage form and the content of the active substance in the dosage form

(a)  

to ensure that each unit in a batch should have drug substance content within a narrow range around the label claim.

(a)  

Weight variation is allowed for hard capsules, uncoated tablets, and filmcoated tablets containing 25 mg or more of the drug substance comprising 25% or more of the weight of the dosage unit

(a)  

Based on the assay of the individual content of drug substance(s) in several dosage units to determine whether the individual content is within the limit sets.

(a)  

Less then 300 mg

(a)  

300 mg or more

(a)  

is defined as the state in which any residue of the unit remain on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core

(a)  

To determine the whether the tablet, capsules, or granules disintegrate within the prescribed time when placed in liquid medium.

(a)  

Uncoated tablet time

(a)  

Plain Coated Tablet time

(a)  

Enteric Coated Tablet

(a)  

Buccal tablets

(a)  

Hard Gelatin Capsules time

(a)  

Soft Gelatin Capsules time

(a)  

Enteric Capsules

(a)  

Water, 5 minutes Gastric juice, 1 hour Intestinal juice, 1 hour

(a)  

Water, 30 minutes

(a)  

Water, 4 hours

(a)  

Water, 3 minutes

(a)  

Reciprocating cylinder

(a)  

Basket

(a)  

Paddle

(a)  

Flow-through cell

(a)  

Paddle over disk

(a)  

Rotating cylinder

(a)  

Reciprocating Holder

(a)  

sufficient media to ensure unimpaired dissolution

(a)  

Applicable to most tablet, this test supplements other physical strength measurements, such as Hardness test.

(a)  

Maximum weight loss of friability testing

(a)  

Tablets must withstand the rigors of handling and transportation experienced in the manufacturing plant.

(a)  

measures the mechanical integrity of the tablet. It is the force that required to cause them to fail

(a)  

the crushing strength

(a)  

Tablet is of proper hardness if it was firm enough to break with a sharp snap when held between 2nd and 3rd fingers, using thumb as fulcrum.

(a)  

Ordinary compressed tablets

(a)  

Sublingual tablets

(a)  

Chewable tablets

(a)  

Buccal tablets

(a)  

must be carefully controlled all throughout the productionry

(a)  

(a)   can vary with no change in weight due to difference in the density of granulation and the pressure applied to the tablets, as well as the speed of tablet compression

To ensure that every production will fit the selected packaging component

(a)  

applicable to powders and granules; in the evaluation of the flow property and compressibility

(a)  

most rapid in Particle Size Distribution Techniques

(a)  

the number of linear openings per square inch

(a)  

Do not pass mesh no. 20

(a)  

Pass mesh no. 20 Do not pass mesh no. 40

(a)  

Both pass on mesh no. 20 and no. 40

(a)  

Defined as the maximum angle possible between the surface of a pile of powder and the horizontal plane.

(a)  

Is a characteristic related to interparticulate friction

(a)  

Fixed-funnel method

(a)  

25 – 30

(a)  

31 – 35

(a)  

36 – 40

(a)  

41 – 45

(a)  

46 – 55

(a)  

56 – 65

(a)  

>66

(a)  

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

(a)  

LAL reagent

(a)  

Chorionic gonadotropin

(a)  

Oxytocin

(a)  

Particles from nonproduct material and not related to the product manufacturing process

(a)  

Particles from non-product material related to product manufacturing process

(a)  

Liquid preparation will run to the tube. The laser will then emit light that will hit the particles of the liquid preparation, in which will also be detected by the photocell detector.

(a)  

Provides trend analysis to identify the problem

(a)  

Requires routine preventive maintenance and calibration

(a)  

Quickly identify, size and count the particles

(a)  

Constant in-process measurement

(a)  

ELECTRONIC PARTICLE COUNTERS

(a)  

Product related particulate that is round or amorphous particle that could be translucent to whitish and naturally buoyant in the solution

(a)  

Insulin, Metocurine & Tubocurarine injection

(a)  

Term for mixture of solid particles and liquid droplets in the air.

(a)  

Heparin and Protamine

(a)  

Parathyroid injection

(a)  

Glucagon

(a)  

Digitalis

(a)  

Vasopressin injection

(a)  

COD liver oil

(a)  

Corticotrophin injection

(a)  

Rabbit Pyrogen Test, Dose:

(a)  

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

(a)  

Rabbit Pyrogen Test • General Chapter

(a)  

(+): development of color in presence of material endotoxins / presence of turbidity

(a)  

These are pourable and designed to provide rapid therapeutic effect.

(a)  

(+): formation of ge

(a)  

Chinese horshoe crab

(a)  

Atlantic horseshoe crab

(a)  

Bacterial Endotoxin Test (BET) • General Chapter

(a)  

are bacteria, viruses, or other microorganisms that cause diseases

(a)  

Test articles are inoculated directly into tubes or bottles that may contain appropriate medium that are incubated for periods of days

(a)  

Radiation

(a)  

Ethylene oxide

(a)  

Dry heat

(a)  

Moist heat

(a)  

used to validate the sterilization process of a pharmaceutical product whether it is successful or not

(a)  

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

(a)  

For Large Volume Parenterals ≥ 25 μm: 2 per mL Microscopic method

(a)  

For yeasts and molds

(a)  

For Large Volume Parenterals ≥ 10 μm: Microscopic method

(a)  

Incubated for 14 days at 20-25 degrees Celsius.

(a)  

Primary intended for the culture of both fungi and aerobic bacteria. There is specific role of some ingredients.

(a)  

▪ Incubated for 14 days at 30-35 degrees Celsius

(a)  

DIRECT INOCULATION is also known as

(a)  

is the method of choice for pharmaceutical products. This is an effective accepted technique for testing fluid samples for microbiological contamination. It utilizes a filter paper with a pore size of 0.45 micrometer

(a)  

– free from germs

(a)  

• Determination of the presence or absence of viable organisms

(a)  

For Large Volume Parenterals ≥ 25 μm: Light obscuration

(a)  

General Chapter for Sterility Test

(a)  

process of removing those germs

(a)  

For Large Volume Parenterals: ≥ 10 μm = Light obscuration

(a)  

MEMBRANE FILTRATION

(a)  

The liquid preparation will be filtered using a filter paper with the pore size of 0.40-0.45 micrometer.

(a)