Blogs

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...

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-mutagenic impurities and...

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...

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 triple bond,...

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 actually formed...

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; skin, blood, kidney, eye, thyroid and intestinal disorders (e.g., colitis); severe allergies;...

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 be seen...

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,...

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 of the results....

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 stability period, degradation products can be formed due to chemical changes in the drug, influenced by certain factors such as light, temperature,...

By Susana Franco An analytical method is a sequence of steps that allows us to have our sample in the necessary conditions to obtain information about its composition, structure, and/or properties; such method can be classified according to the type of analysis that is performed, as qualitative or quantitative; also by the type of analytical technique used to determine the properties of the sample....

Let's know what organic impurities are and how they can affect drug quality. Organic impurities are chemical substances that are present in a drug, but are not part of the desired active substance. These impurities can have different origins, from used reagents or by-products generated during API synthesis to degradation products or...

Risk analysis is a way of examining a hazard in order to avoid or reduce it by determining the severity and likelihood of harm to human health or the ecosystem from exposure to a toxic chemical compound. Toxicological risk is estimated by looking at the potential of a specific chemical compound released into the environment and the...

The toxicity of substances contained as impurities in medicines is of paramount interest to consumers, who demand assurance that products do not harm their health or well-being. The cost of ignoring this fact is enormous for companies: in addition to the direct impact on people, errors damage the integrity of the brand and the...

Qualification is the process of establishing the biological safety of a product in the presence of a degradation compound or impurity above specified levels. A reasoned method must be used to establish acceptable criteria for impurities and must include the safety criteria considered. The interpretation of the regulation is very important to define...

Quantitative Structure Activity Relationships (Q)SAR models are based on one of the most widely used techniques in the field of chemoinformatics. They are complex mathematical algorithms that facilitate, economize and accelerate the predictive evaluation of the biological properties or activities of chemical compounds based exclusively on their molecular structure. They are based on...

What are pesticides? What do you need to approve the registration of pesticides in Mexico? Pesticides or biosides are types of chemical compounds intended to repel, destroy or prevent any undesirable species of plants or animals. They are used during the production, storage, transport and distribution stages of food of agricultural origin, whether it is food for humans or animals.

What is a degradation compound in medicines and how does it affect us? Degradation compounds are substances produced by the breakdown of the active ingredient. Various impurities may result due to degradation of the active ingredient or some other interaction in storage, so stability studies need to be performed to ensure the safety of the product. The presence...

Why does a person who studies chemistry end up being a salesperson? What would they answer if we were to ask chemistry and related careers students if they see themselves working as salespeople? Surely the answer is a resounding no. Most students think of working in a laboratory of a pharmaceutical or any other chemistry company when they leave college. Most students think of working in a laboratory of a pharmaceutical company or any other chemistry company when they leave the university...