1. INTRODUCTION

2. NITROSAMINE IMPURITIES

3. SOURCES OF NITROSAMINES

3.1 Nitrosamine Formation Reaction

4. NITROSAMINE RISK ASSESSMENTS—DEVELOPMENT OF A CONTROL STRATEGY

5. LIMITS OF NITROSAMINES

5.1 Derivation of AI Limits

5.2 Example Calculations of Nitrosamine Limits

6. TESTING FOR THE PRESENCE OF NITROSAMINES

6.1 Presence of Two or More Nitrosamines

7. TEST METHOD PERFORMANCE CHARACTERISTICS OF NITROSAMINE METHODS

7.1 Considerations for Sample Preparation

8. ANALYTICAL PROCEDURES

8.1. Quantitative Procedures

8.2. Limit Test Procedures

9. ADDITIONAL SOURCES OF INFORMATION

10. USP REFERENCE STANDARDS

REFERENCES