Study Set Content:
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.
MONOGRAPH
A document that specifies all the tests to be
conducted on a product and/or appropriate
references containing details of procedure and
expected results.
MONOGRAPH
It is a written document that reflects the quality
attributes of medicines
MONOGRAPH
KEY ATTRIBUTES
Identity
Strength
Purity
Performance
Tests to identify that a particular
substance is the medicine that claims to be
Identity
Testing methods and acceptable
ranges for the potency of a medicine.
Strength
Information on impurities that may be
present in a medicine and the amount of these
that are permitted.
Purity
Laboratory tests to predict and
demonstrate how a medicine will be released as
it enters the human body.
Performance
COMPONENTS OF MONOGRAPH
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
Two main types of product testing:
Compendial and non-compendial
This is just another word for
monograph.
Compendial:
Compendial testing includes
validated, standardized specifications, test
methods for a specific product, compound,
substance.
There are many advantages to
compendial testing, a main one being_____
of validating tests on your own.
avoidance
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)
more
straightforward
This is any testing not
specified in a monograph, including in house
and independent lab procedures
Non-compendial:
While these testing methods are usually scientifically
reliable, they do not have the same _____ to ensure between-lab
reproducibility.
rigorous validation workflow
Benefits of non-compendial
testing includes
customized approaches to unique ingredients,
flexible problem-solving
more identification possibilities.
Thermal and physical tests
These are some examples of straightforward tests to
confirm the basic physical properties of a
product.
pH, melting point, boiling point, flash point,
density, particle size, appearance color
They are standard methods that can be
performed in most labs, but are rarely the only
component of a monograph.
Thermal and physical tests
An approach to measure the thermal stability of a
product, as well as its volatile components
Thermal gravimetric analysis (TGA):
