PRELIM 02 - Monograph

Question 1

Sets forth the article’s name, definition, specification, and other requirements related to packaging, storage, and labeling

Answer 1

Monograph

Question 2

7 information included in a monograph (DSDSCQT)

Answer 2

Drug, Safety, Dosage, Storage, Clinical trial, Quality, Testing

Question 3

2 types of monograph (PO)

Answer 3

Pharmacopeia monograph, OTC monograph

Question 4

Came from stakeholders from academic industries and regulators (Types of monograph)

Answer 4

Pharmacopeial monograph

Question 5

Created and controlled by the FDA (Types of monograph)

Answer 5

OTC monograph

Question 6

Used for active ingredients named in defining the required strength of a compendial article (Components of monograph)

Answer 6

Molecular formula

Question 7

Are presumed to be unsuitable for inclusion in an official article if they exceed the minimum quantity required for providing their intended effect (Components of monograph)

Answer 7

Added substances

Question 8

The approximate solubility of a compendial substance is indicated by descriptive terms (Components of monograph)

Answer 8

Description and solubility

Question 9

Provided as an aid in verifying the identity of articles as they purported to be (Components of monograph)

Answer 9

Identity

Question 10

Intended to serve as the official test in the event of a question or dispute regarding the preparation’s conformance to official standards (Components of monograph)

Answer 10

Assay

Question 11

Are provided to limit such substances to amounts that are unobjectionable under conditions in which the article is customarily employed (Components of monograph)

Answer 11

Impurities and foreign substances

Question 12

Where content uniformity determinations have been made using the same analytical methodology specified in the assay (Components of monograph)

Answer 12

Performance tests

Question 13

Are authentic specimens that have been approved as suitable for use as comparison standards in USP or NF tests and assays (Components of monograph)

Answer 13

USP reference standards

Question 14

Very soluble (Parts of solute)

Answer 14

<1

Question 15

Freely soluble (Parts of solute)

Answer 15

1-10

Question 16

Soluble (Parts of solute)

Answer 16

10-30

Question 17

Sparingly soluble (Parts of solute)

Answer 17

30-100

Question 18

Slightly soluble (Parts of solute)

Answer 18

100-1000

Question 19

Very slightly soluble (Parts of solute)

Answer 19

1000-10,000

Question 20

Practically insoluble (Parts of solute)

Answer 20

> 10,000