Rao, Ganpisetti Srinivasa published the artcileNovel stability indicating LC-MS method for N-Nitroso dimethyl amine genotoxic impurity quantification in ranitidine drug substance and drug product, Name: 1,3-Dimethoxybenzene, the main research area is .
Nitrosamine impurities are potential carcinogens, which are forming from the synthesis of drug substance as byproduct and also forming in presence of NaNO2/HNO3 and secondary amines (e.g., di-Me amines, di-Et amine etc.,), which should be controlled in the medication of the human beings. Hence, robust and sensitive anal. method is required to control the nitroso amine impurities in drugs. The object of this method is to quantify the N-Nitrosodimethylamine (NDMA) impurity at 0.01 ppm level in ranitidine drug substance (form-1 and form-2) and drug product (tablets and capsules) of different geog. The source of NDMA impurity is also from the di-Me amine as a key starting material using the ranitidine synthetic process. NDMA is forming when di-Me amine is reacting with nitrous acid. The optimized LC method conditions were ACE C18-AR 3 μm, 150 ~ 4.6 mm column, mobile phase A as 0.1% formic acid in water, mobile phase B as 100% methanol, 0.8 mL/min flow with gradient (time/%mobile phase B): 0/3, 3/3, 15/15, 15.1/100, 17/100, 17.1/3, 22/3, column temperature: 40°C, injection volume 50 μl, and total run time as 22 min. The final response achieved with multiple reaction monitoring (MRM) type: MRM [Q1 Mass (Da):75 Q3:58.2 Time (msecond)] in atm. chem. ionization pos. mode. The optimized method was validated against the International Council for Harmonisation Q2 (R1) and United States of Pharmacopeia general chapter for compendial method validations 1225. This method can detect up to 0.01 ppm and quantify up to 0.03 ppm, the method shows linearity from 0.03 to 20 ppm.
Journal of Applied Pharmaceutical Science published new progress in CAplus about 151-10-0, 151-10-0 belongs to class isoquinoline, name is 1,3-Dimethoxybenzene, and the molecular formula is C8H10O2, Name: 1,3-Dimethoxybenzene.
Referemce:
Isoquinoline – Wikipedia,
Isoquinoline | C9H7N – PubChem