Enumerate the 4 guidelines of ICH.

(a)  

Q6 or?

(a)  

PDG or?

(a)  

The term that includes both the mass of the dosage form and the content of the active substance in the dosage form.

(a)  

It is defined as the degree of uniformity in the amount of the drug substance among dosage unit.

(a)  

It confirms uniformity of the dosage unit and therefore support product safety, identity and quality. It is allowed for hard capsules, uncoated tablets, and film-coated tablets containing 25 mg or more of the drug substance compromising 25% or more of the weight of the dosage unit.

(a)  

It is based on the assay of the individual content of drug substance in several dosage units to determine whether the individual content is within the limits set.

(a)  

It ensures that the strength of a therapeutic product remains within specified acceptance limits. It is applicable to dosage units with <25 or <25% of drug substance.

(a)  

It is defined as that 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)  

It determines whether the tablet, capsule, or granules disintegrate within the prescribed time when placed in liquid medium.

(a)  

Uncoated tablets are marked as PASSED in the disintegration test if (a)   tablets are completely disintegrated.

If 1-2 uncoated tablets failed, repeat the test on additional (a)   tablets.

Enteric coated tablets are marked as PASSED in the disintegration test if after (a)   hours, no tablets disintegrated in acid stage.

A test provided to determine compliance with the dissolution parameters for dosage form administered orally.

(a)  

Type 1 media used in dissolution test: (a)   rpm

Type 2 media used in dissolution test: (a)   rpm

A condition wherein a sufficient media to ensure un-impaired dissolution.

(a)  

A test that only applies to different types of tablets.

(a)  

A test that compliments physical strength measurements, such as Hardness Test.

(a)  

Friability Tester: (a)   rotation per minute.

Brushing the fine particles adhering on each sample units in the Friability Test.

(a)  

Hardness test applies the (a)   that required the tablet to break or fail.

(a)   is the crushing strength.

Thickness (and Diameter) is also called (a)   Test.

Scale used in Vernier caliper for whole numbers.

(a)  

Scale used in Vernier caliper for decimals.

(a)  

A specific test for powders and granules.

(a)  

A test used for the evaluation of the flow property and compressibility.

(a)  

The most rapid technique of Particle Size Distribution.

(a)  

It is defined as the maximum angle possible between the surface of a pile of powder and the horizontal plane.

(a)  

It is a characteristic related to inter-particulate friction. It is AKA Fixed-funnel method.

(a)  

These are the excipients in the compression of the powders.

(a)  

It measures the flow property, the ability to settle, and the inter-particulate interaction.

(a)  

An automated volumeter used in the bulk and tapped density that measures the amount of granules.

(a)