Substance Registration System Database, FDA

Developing structure guidelines and updating the registration system.

Cygnus staff was responsible for updating the Federal Drug Administration (FDA) Substance Registration System (SRS). Cygnus staff verified the chemical structures by comparing the structures to their representations and to their names in FDA's printed ingredient dictionary, the U.S. Adopted Names dictionary, the U.S. Pharmacopeia, and other authoritative sources. Emphasis was placed on adding and correcting stereochemistry to ensure that a substance had a single unique entry in the database.

Our team also assisted in the development of structure guidelines, incorporating the updated structures into the registration database, and provided consultation on the design of the SRS. Cygnus personnel used in-depth knowledge of chemical databases and associated Web applications to improve design of the SRS. Services and scientific expertise provided by Cygnus included some of the following:

  • Legacy chemical structure enhancement;
  • Creation of omitted and new chemical structures;
  • Chemical structure guideline development;
  • Transfer of chemical structures into SRS; and
  • Consultation on SRS design.

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