Study Set Content:
1- Flashcard

It is a book, pamphlet or document that is

complete in itself or it is detailed written study of

a single specialized subject or an aspect of it.


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2- Flashcard

A document that specifies all the tests to be

conducted on a product and/or appropriate

references containing details of procedure and

expected results.


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3- Flashcard

It is a written document that reflects the quality

attributes of medicines


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4- Flashcard






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5- Flashcard

Tests to identify that a particular

substance is the medicine that claims to be


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6- Flashcard

Testing methods and acceptable

ranges for the potency of a medicine.


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7- Flashcard

Information on impurities that may be

present in a medicine and the amount of these

that are permitted.


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8- Flashcard

Laboratory tests to predict and

demonstrate how a medicine will be released as

it enters the human body.


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9- Flashcard


1. Molecular Formula

2. Added Substances

3. Description and Solubility

4. Identification

5. Assay

6. Impurities and Foreign Substances

7. Performance Tests

8. USP Reference Standards

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10- Flashcard

Two main types of product testing:

Compendial and non-compendial

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11- Flashcard

This is just another word for



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12- Flashcard

Compendial testing includes

validated, standardized specifications, test

methods for a specific product, compound,


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13- Flashcard

There are many advantages to

compendial testing, a main one being_____

of validating tests on your own.


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14- Flashcard

Additionally, regulatory agencies are familiar with, and

typically expect, the outcomes of compendial

testing, making the approval and review

processes (or any post-distribution follow-ups)



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15- Flashcard

This is any testing not

specified in a monograph, including in house

and independent lab procedures


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16- Flashcard

While these testing methods are usually scientifically

reliable, they do not have the same _____ to ensure between-lab


rigorous validation workflow

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17- Flashcard

Benefits of non-compendial

testing includes

customized approaches to unique ingredients,

flexible problem-solving

more identification possibilities.

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18- Flashcard

Thermal and physical tests

These are some examples of straightforward tests to

confirm the basic physical properties of a


pH, melting point, boiling point, flash point,

density, particle size, appearance color

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19- Flashcard

They are standard methods that can be

performed in most labs, but are rarely the only

component of a monograph.

Thermal and physical tests

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20- Flashcard

An approach to measure the thermal stability of a

product, as well as its volatile components

Thermal gravimetric analysis (TGA):

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