The document discusses the Inactive Ingredient Guideline (IIG) published by the FDA. The IIG provides information on inactive ingredients used in drug products, including definitions of active and inactive ingredients. It describes the various fields included in the IIG such as ingredient name, route of administration, CAS number, UNII, maximum potency, and potency range. The purpose of the IIG is to establish quantities of inactive ingredients for specific dosage forms and administration routes, and to provide guidance for new drug development. It aims to standardize quality review of inactive ingredients in drug applications.

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Inactive ingredient guideline
By Saroj Makwana

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Introduction
• IIG is a part of FOI Special Topics, which comes under
Drug Information division of CDER.
• IIG was prepare on January 1996
• PDF version available on FDA from March 2000 –
scanned document
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Active ingredient
Definition:
(according to 21 CFR 210.3(b)(7))
• Include those components of the product that may
undergo chemical change during the manufacture of
the drug product and be present in the drug product
in a modified form intended to furnish the specified
activity or effect.
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Inactive Ingredients
Definition
(According to 21 CFR 210.3(b)(8))
• Only inactive ingredients in the final dosage forms
of drug products are in the database of inactive
ingredient guideline.
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Inactive Ingredients
• Inactive ingredients are components of a drug
product that do not increase or affect the therapeutic
action of the active ingredient, which is usually the
active drug.
• Inactive ingredients are added during the
manufacturing process of pharmaceutical products
such as tablets, capsules, suppositories, and
injections.
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• Inactive ingredients may also be referred to as inert
ingredients or excipients, and generally have no
pharmacological effect.
• Examples:
• Binding materials
• Dyes,
• Preservatives,
• Flavoring agents.
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Purpose
• Establishing the required quantities of the inactive ingredient for
a particular dosage form with a specified route of administration
is one another critical step involved in the design of a
formulation.
• USFDA has provided information to some extent with relating to
maximum potency of the inactive ingredient for a specific
dosage form with specific route of administration.
• USFDA indicates that for new drug development purposes,
once an inactive ingredient has appeared in an approved drug
product for a particular route of administration, the inactive
ingredient is not considered new and may require a less
extensive review the next time it is included in a new drug
product.

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IIG Description
NAME ROUTE
/DOSAGE
FORM
CAS
NUMBER
UNII MAXIMUM
POTENCY
POTENCY
RANGE
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1. INACTIVE INGREDIENT NAME:-
• Alphabetically listed Starting from ACACIA to ZINC SULFATE
• Then few excipients as per Numerical starting
e.g. 1, 1, 1 – TRICHLOROETHANE

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2.ROUTE /DOSAGE FORM
•DOSAGE FORM :
– Tablet: Delayed
action, Enteric
Coated
– Emulsion
– Suspension
•ROUTE :
– Buccal
– I.M.
– I.V.
– Ophthalmic
– Oral
– Topical

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3.CAS No.
• Chemical Abstract Service No.
• 9 digit
• Provides comprehensive electronic chemical
information services.
• Helpful in Computer-assisted search with the
National Library of Medicine’s Online Databases
for chemical information
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4. UNII
• Unique Ingredient Identifier
• Part of the joint United States Pharmacopeia (USP)/FDA
Substance Registration System (SRS)
• Provide unique identifiers for substances in drugs, biologics,
foods, and devices based on molecular structure and/or
descriptive information.
• The SRS is used to generate permanent, unique, identifiers
for substances in regulated products, such as ingredients in
drug products.
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5. Maximum potency
• The "maximum potency" field specifies the maximum
amount of inactive ingredient for each route/dosage
form containing that ingredient.
• When there is no calculable potency measurement for
the inactive ingredient, the "maximum potency" field
will be blank.
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6. POTENCY RANGE
• Minimum to Maximum Value of Excipients used
• i.e. 0.5 mg – 5 mg
• In many excipient Potency Range is given in
Percentage of final product
• i.e. 0.5 % - 5 %
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Study Questions
1) Write a note on IIG. (June/July- 2011, July
2010,2012)
2) What is objective of IIG? Explain general
description of IIG.(Dec. – 2011, Winter- 2012)
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REFERENCES:
www.fda.gov
www.fda.gov/cder/drug/iig/default.htm
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