N-nitrosamine risk assessments for oral dosage forms: Nitrite content in the microcrystalline cellulose (MCC)

INTRODUCTION The effects of N-nitroso compounds on human health (particularly their role in gastric cancer) are well known.1 Certain N-nitrosamines are described as highly probable human carcinogens. They are usually formed by the reaction of secondary or tertiary amines with a source of a nitrosating agent, typically derived from nitrite.2,5 Oral excipients are considered as … Continue reading N-nitrosamine risk assessments for oral dosage forms: Nitrite content in the microcrystalline cellulose (MCC)