Monograph

Question 1

set forth of article’s name, definition, specification and other requirements

Answer 1

Monograph

Question 2

A component that may include information regarding the article’s description. Only where the quantitative solubility test is given in a monograph and designated as test for purity
- may be indicated by one of the following descriptive terms

Answer 2

Description and Solubility

Question 3

7 contents of monograph (information)

Answer 3

1. drug info
2. safety info
3. dosage info
4. storage info
5. clinical trial info
6. quality info
7. testing info

Question 4

OTC monograph is controlled and created by

Answer 4

FDA

Question 5

It is created or controlled by stakeholders from academic industry and regulators

Answer 5

Pharmacopoeia Monograph

Question 6

• One of the component that aid in verifying identity of articles as they purported
• may consist of one or more procedures
• indicates if the article is mislabeled or adulterated

Answer 6

Identity/Identification

Question 7

One of the components that discuss use for active ingredients named in defining the required strength of a compendial article
- must have complete set of atoms and have absolute (100%) purity

Answer 7

Molecular formula

Question 8

A component that is test for compounded preparations is not intended for evaluating a compounded preparation before dispensing

• intended as official test in the event of a question or dispute regarding the preparation’s conformance to official standards
• test for purity

Answer 8

Assay

Question 9

• external or outside source such as environmental contamination and improper handling

Answer 9

Foreign Substance

Question 10

can be inherited during manufacturing process

ex residual products

Answer 10

Impurities

Question 11

A component where content uniformity determinations have been made using the same analytical methodology specified in the Assay

Answer 11

Perfomance test

Question 12

Added Substance are presumed to be unsuitable for inclusion and therefore prohibited if:

Answer 12

• exceed minimum quantity required for providing intended effect
• their presence impairs the bioavailability
• they interfere with the assays and tests prescribed for determining compliance with compendial standards ( triplicate tests)

Question 13

8 components/content of monograph

Answer 13

1. Molecular Formula
2. Added Substances
3. Description and Solubility
4. Identity
5. Assay
6. Impurities and Foreign Substances
7. Performance Test
8. USP Reference Standards

Question 14

less than 1

Answer 14

very soluble

Question 15

1-10

Answer 15

freely soluble

Question 16

10-30

Answer 16

soluble

Question 17

30-100

Answer 17

Sparingly soluble

Question 18

100-1000

Answer 18

Slightly soluble

Question 19

1,000 - 10,000

Answer 19

Very Slightly soluble

Question 20

Greater than/ equal to 10,000

Answer 20

Practically Insoluble