By Karen Roldán Phytosanitary regulation in Argentina is evolving toward more modern, scientific approaches that are aligned with international standards. With the entry into force of SENASA Resolution 458/2025 and its amendment 843/2025, a key opportunity has opened up for companies seeking to register new or equivalent active substances, incorporating QSAR and in silico methodologies as valid toolswithin... Read More... "Phytosanitary Registration in Argentina: QSAR and In Silico under Resolution 458/2025"
Category: News
Qualification of Non-Mutagenic Impurities: Modern Strategies and Risk Assessment
By Victor Abrego The evaluation of non-mutagenic impurities (NMIs) is a critical aspect of pharmaceutical development, ensuring that products are safe for human consumption. While the ICH Q3A and Q3B guidelines establish a general framework, challenges remain in qualifying impurities that are new or at higher concentrations than previously evaluated. How do you evaluate non-mutagenicimpurities and... Read More... "Qualification of Non-Mutagenic Impurities: Modern Strategies and Risk Assessment".
Nitrosamines
By Karen Roldán Nitrosamines, chemical compounds with known carcinogenic potential, have generated concern in various sectors, particularly in the pharmaceutical industry. Since their discovery in the 1950s, they have been the subject of extensive studies due to their potential adverse effects on human health. At QSAR Analytics, we understand the importance of addressing this challenge with scientific solutions... Read More... "Nitrosamines"
Elimination Reaction
By Daniela Alva An elimination reaction is one in which one or two substituents are removed from the original molecule. The elimination can proceed through a one-step or two-step mechanism, known as E1 and E2 elimination, respectively. In both types of mechanisms, the elimination results in the formation of a double bond, a triplebond, a... Read More... "Elimination Reaction"
Oxidation Reactions
By Samanta Adam Introduction The control of degradation products in pharmaceuticals remains a challenging task among pharmaceutical scientists. The forced degradation guideline recommended by the International Conference on Harmonization (ICH) is used to identify potential degradation products, which are formed during stress degradation, but are actuallyformed... Read More... "Oxidation Reactions".
Obtaining acidic dexamethasone from dexamethasone
By Arturo Rodriguez Dexamethasone is a synthetic glucocorticoid, that is, it is similar to a natural hormone produced by the adrenal glands, used mainly for its potent anti-inflammatory effect, so it is used to treat certain forms of arthritis; disorders of the skin, blood, kidney, eyes, thyroid and intestines (e.g., colitis); severe allergies;... Read More... "Obtaining acid dexamethasone from dexamethasone".
Maillard's reaction
By Nayeli Ramirez Most drug degradation mechanisms include hydrolysis/dehydration, oxidation, isomerization/epimerization, decarboxylation, rearrangement, dimerization/polymerization and photolysis reactions. Some reactions, also, involve interaction with some excipients. The formation of degradation products can take place under different conditions, including acidic, basic, oxidative and photolytic conditions. Hydrolysis reactions can beseen as a result of... Read More... "Maillard's reaction".
Esterification and its impact on the pharmaceutical industry
By Daniel Hernandez Esterification is a type of chemical reaction typical of carbonyl compounds. It occurs when a carbonyl compound (such as a carboxylic acid or a ketone) reacts with a nucleophile, such as an alcohol, under acidic or basic conditions to form an ester and release a water molecule. The esters produced are very important compounds in industry, as they can be... Read More... "Esterification and its impact on the pharmaceutical industry".
Importance of Material Washing for Impurity Analysis in Drugs
By Juan David López The analysis of impurities in drugs is a critical stage in pharmaceutical production, as it ensures that products are safe, effective and meet established quality standards. A fundamental aspect in this process is the proper washing of the material used in drug analysis, which guarantees the reliability ofthe results.... Read More... "Importance of Material Washing for the Analysis of Impurities in Medicines".
Decarboxylation in drug stability
By José Juan Martínez As we know, drug stability is the ability of the drug within a sealed container to maintain during a period of storage and use the established quality specifications. During this period of stability, degradation products can be formed due to chemical changes in the drug, influenced by certain factors such as light, temperature,... Read More... "Decarboxylation in drug stability".
