IIG is a special part of FOI which includes list of inactive ingredient.

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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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