Inactive Ingredient Guide

U.S. Food and Drug Administration. FDA Inactive Ingredients Guide. Rockville, Maryland Division of Drug Information Resources, 1996. 

U.S. Department of Health and Human Services. Inactive Ingredient Guide. Food and Drug Administration. 

Choosing an acceptable preservative when developing an oral liquid formulation is primarily limited by the number of approved excipients. As Table 10 demonstrates, there are many preservatives listed in the FDA inactive ingredient guide for dosage forms other than oral liquids however not many have been commonly used in oral solutions or suspensions. 

CDER-approved products are considered those subject to an approved NDA or ANDA. Some information on which components/materials aie used in CDER-approved products is available from the Agency (e.g., FDA, CDER, Inactive Ingredient Guide, 1996, Division of Drug Information Resources). When infonnation is not available, an applicant should use reliable sources of infonnation to determine that the component or material has been used in and has been in contact with a CDER-approved product of the same dosage form and route of administration, as appropriate. The applicant should identify in the supplement or annual report the basis for the conclusion that the component or material is used in a CDER-approved product. 

Inactive ingredient guide. (2006) http //www.fda.gov/cder/drug/iig/default.htm... 

Aspartame is GRAS listed, and is accepted as a food additive in Europe and is in the FDA Inactive Ingredients Guide. It is included in non-parenteral medicines licensed in the UK, and is listed in the USP-NF, BP, JP, and EP. Aspartame is the subject of a monograph in the Food Chemicals Codex issued by the National Academy of Sciences. This document is very similar to the corresponding USP-NF monograph. 

Inactive Ingredients Guide Division of Drug Information Resources United States Food Drug Administration Center for Drug Evaluation Research (CDER) Rockville, MD, Jan 1996. 

Table 10 List of excipients from the 1996 FDA inactive ingredient guide...

Inactive Ingredient Guide,, Division of Drug Information Resources, Food Drug Administration, CDER, January 1996.,. 

GRAS listed. Accepted for use in Europe as a food additive. Included in the FDA Inactive Ingredients Guide (oral preparations and buccal or sublingual tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 

Included in the FDA Inactive Ingredients Guide for oral and sublingual preparations. Included in the Canadian List of... 

---