31
_____________________________________________________________ 3AQ5a ■
CHEMISTRY OF ACTIVE SUBSTANCES
Guideline Title
Chemistry of Active Substances
Legislative basis
Directive 75/318/EEC as amended
Date of first adoption
October 1987
Date of entry
into
force
October 1987
Status
Last revised 1987
Previous titles/other
references
Chemistry of Active Ingredients
Additional Notes
This note for guidance concerns the application of Part
2, section C of the Annex to Directive 75/318/EEC as
amended with a view to the granting of a marketing
authorisation for a medicinal product. The section on
impurities is replaced by the guideline Impurities in
New Active Substances for new active substances. For
abridged applications, biotechnological/biological
products and other products exempted from the
“impurities” guideline, these requirements continue to
apply.
CONTENTS
1.
INTRODUCTION
2.
IDENTITY OF MATERIALS
3.
MANUFACTURE
4.
DEVELOPMENT CHEMISTRY
5.
IMPURITIES
6.
ACTIVE SUBSTANCE SPECIFICATION
7.
BATCH ANALYSIS
8.
REFERENCE STANDARDS
9.
RADIOLABELLED PRODUCT
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_____________________________________________________________ 3AQ5a ■
CHEMISTRY OF ACTIVE SUBSTANCES
1.
INTRODUCTION
The purpose of this note for guidance is to set out the type of information required for the
control of new active substances used for the first time in a medicinal product, which are not
described in the European Pharmacopoeia or a pharmacopoeia of a Member State.
2.
IDENTITY OF MATERIAL
This section deals with the identity, nomenclature and chemical structure of the active
substance which is the subject of the application for marketing authorisation. Only brief
details of physical characteristics should be stated, as full details and proof of structure are
required later.
2.1 Nomenclature
–
International Non-Proprietary Name (INN),
–
National Approved Names, ( )
–
US Adopted Name (USAN),
–
Laboratory Code(s),
–
Systematic Chemical Name(s),
–
Other Names (e.g. Proprietary).
+
2.2 Description
–
physical form,
–
structural formula,
–
molecular fo