EA Review #1, NDA 20-358

Page 5

5.

Identification of chemical substances that are the subject of the proposed action:

Drug Substance:

Generic Name:      

Bupropion hydrochloride

Chemical Name:

          (IUPAC)

(+, -)-2-(tert-Butylamino)-3’-chloro-

propiophenone hydrochloride

Chemical Name:

          (Chem Abstr)

(+,-)-1-(3-Chlorophenyl)-2-

[1,1-dimethylethyl amino]-1-propanone

hydrochloride

CAS #:

[31677-93-7]

Molecular Weight:

276.21

239.74 (base)

Molecular Formula:

C₁₃ H₁₈ ClNOÞHCl

Structural Formula:

See page 5 of EA

Physical Descrip.:

White powder

Additives:

Additives are listed in Confidential

Appendix A under three categories: core

ingredients, coating ingredients, and

printing ingredients

Adequate.

Impurities:

A total of seven impurities are identified in Confidential Appendix A, and their chemical name and structure are given.  Three of the impurities are each present at less than 1% each.  Three are present at less than 2% each.  One is present at less than 5%.  Total unidentified compounds do not exceed 2% and total related substances do not exceed 8%.

Adequate

6.

Introduction of substances into the environment: For the site(s) of production:

a.       Potential Emitted Substances:

          A list of materials used in each stage of the synthesis of drug substance is provided in           Confidential Appendix B.  The identity and amount of materials generated at each stage are also           given.

          Adequate.