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NITROSAMINE. IMPURITIES. A magnifying glass over a pill Description automatically generated.

NITROSAMINE. A black background with a black square Description automatically generated.

Global Concern & Potential Risk. Close up of pills in a pile Description automatically generated.

What is nitrosamine Impurities. N-nitrosamines (nitrosamines) is a class of organic compound that are associated with mutagenic carcinogens..

Formation of Nitrosamine in Drug product. Nitrite can form the reactive species nitrous anhydride (N2O3) under mildly acidic conditions. N-nitrosamines Formation Presence of Nitrosating agent (nitrites and nitrates) in excipients Presence of secondary or tertiary amine in excipients Nitrates can react to form nitrite through enzymatic reduction,.

General Root Causes of Nitrosamine Impurities. A magnifying glass over pills Description automatically generated.

General Conditions That Lead to Nitrosamine Formation.

Sources of Secondary, Tertiary, and Quaternary Amines That Can Form Nitrosamines.

Contamination in Vendor-Sourced Raw Materials. Nitrosamine impurities can be introduced when vendor-sourced materials, including starting materials and raw materials, are contaminated. The Agency has observed the following contaminations due to this root cause..

Lack of Process Optimization and Control. Another potential source of formation of nitrosamine impurities is lack of optimization of the manufacturing process for APIs when reaction conditions such as temperature, pH, or the sequence of adding reagents, intermediates, or solvents are inappropriate or poorly controlled. * Deviation/Error in process optimization & Contorl can lead to the formation of nitrosamines, due to present of nitrite FDA has seen instances in which reaction conditions varied widely between batches and even between different processing equipment in the same facility for the same API..

Acceptable limits of Nitrosamine Impurities. European Industrial Pharmacists Group (EIPG) Revision of the CDMh's Q&As document on nitrosamine impurities.

FDA recommends the following acceptable intake (AI) limits for the nitrosamine impurities NDMA, NDEA, NMBA, NMPA, NIPEA, and NDIPA..

CAPSULES. A close up of blue liquid. Capsule manufacturing is a physical pin moulding process which does not involve any chemical reaction..

The ingredients used in the manufacturing of our product “Hard Gelatin Capsule Shells & Cellulose Capsules Shells” does not contain the Nitrosamine impurities ..

Screenshot Of Nitrosamine Questionnaire of Hard Gelatin Capsule Shells & Cellulose Capsule Shells.

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