Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices

KM Manchuri, MA Shaik, VSR Gopireddy… - Chemical Research …, 2024 - ACS Publications
Since 2018, N-nitrosamine impurities have become a widespread concern in the global
regulatory landscape of pharmaceutical products. This concern arises due to their potential …

Nitroso impurities in drug products: an overview of risk assessment, regulatory milieu, and control strategy

NA Charoo, S Dharani, MA Khan, Z Rahman - AAPS PharmSciTech, 2023 - Springer
Many nitrosamines have been recognized to be carcinogenic for many decades. Despite the
fact that several nitrosamine precursors are frequently used in the manufacturing of …

N-Nitrosodimethylamine Formation in Metformin Drug Products by the Reaction of Dimethylamine and Atmospheric NO2

S Fukuda, K Kondo, S Fukumoto… - … Process Research & …, 2023 - ACS Publications
In 2019, N-nitrosodimethylamine (NDMA) exceeding the maximum allowable intake (96
ng/day) was detected in metformin drug products in Singapore, and since then, many of the …

[HTML][HTML] NDMA formation due to active ingredient degradation and nitrite traces in drug product

N Golob, S Peterlin, R Roškar - Journal of pharmaceutical sciences, 2023 - Elsevier
N-nitrosamines are genotoxic compounds which can be found as impurities in drug
substances and drug products used in the pharmaceutical industry. To date, several …

Bumetanide as a model NDSRI substrate: n-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets

D Shakleya, B Asmelash, A Alayoubi, N Abrigo… - Journal of …, 2023 - Elsevier
Nitrosamine compounds are classified as potential human carcinogens, the origin of these
impurities can be broadly classified in two categories, nitrosamine impurity found in drug …

Dispersant-first dispersive liquid-liquid microextraction (DF-DLLME), a novel sample preparation procedure for NDMA determination in metformin products

C Géhin, N O'Neill, A Moore, M Harrison… - Journal of …, 2023 - Elsevier
Since December 2019, global batch recalls of metformin pharmaceutical products have
highlighted an urgent need to control N-nitrosodimethylamine (NDMA) contamination to …

Effect of patients in-use and accelerated stability conditions on quality attributes and pharmacokinetic profile of four FDA approved extended-release anti-epileptic …

EM Mohamed, MA Hassan, G Sibhat, T Khuroo… - International Journal of …, 2025 - Elsevier
Divalproex (DVS) is a popular drug widely used in various neurological and psychiatric
disorders. Commercially, it is a multisource-drug available in different generic equivalents …

Development, Pharmacokinetics and Antimalarial Evaluation of Dose Flexible 3D Printlets of Dapsone for Pediatric Patients

AA Khan, T Khuroo, EM Mohamed, S Dharani… - AAPS …, 2024 - Springer
The focus of current studies was to fabricate dose flexible printlets of dapsone (DDS) for
pediatric patients by selective laser sintering (SLS) 3D printing method, and evaluate its …

Patient In-Use Stability Testing of FDA-Approved Metformin Combination Products for N-Nitrosamine Impurity

S Dharani, EM Mohamed, Z Rahman, MA Khan - AAPS PharmSciTech, 2024 - Springer
Abstract Between February 2020 and January 2022, the Food and Drug Administration
(FDA) recalled 281 metformin extended-release products due to the presence of N …

The effect of humidity on the dissolution kinetics and tablet properties of immediate-release tablet formulation containing lamotrigine

M Lalić-Popović, G Švonja Parezanović, N Todorović… - Pharmaceutics, 2022 - mdpi.com
This study aims to find the effects of high (75%) and low (30%) humidity conditions and its
correlation with formulation composition on dissolution kinetics of lamotrigine (LMT) from …