2026 Update on Pharmaceutical Standards
For multinational pharmaceutical companies, CDMOs, biotech innovators, and API manufacturers operating across multiple jurisdictions, regulatory alignment is now a strategic priority
FDA Nitrosamine Categorization: Small-Molecule Nitrosamine and NDSRIs
The issue of nitrosamine impurities has become one of the most significant regulatory concerns in the pharmaceutical industry since 2018.
Difference between Process-Related and Degradation-Related Impurities
Understanding the distinctions between Process Impurities and Degradation Impurities is crucial in pharmaceutical development and quality assurance…
Structure Elucidation of Unknown Impurity using LC-MS/MS
Impurity analysis in pharmaceuticals is a critical quality control measure. Impurities, arising during synthesis, storage, or handling, can significantly affect a drug’s safety, efficacy, and stability…
Advancements in LC-MS Technology
Liquid Chromatography-Mass Spectrometry (LC-MS or LC/MS or LCMS) is an indispensable technology in the realm of pharmaceutical analysis…
The Nitrosamine puzzle: What We Learned in the Last Five Years
The Nitrosamine (NA) issue, often termed the “Saga,” has been a focal point of attention for both the pharmaceutical sector and regulatory entities over the past half-decade…
Impurity Profiling
Impurity profiling plays a crucial role in pharmaceutical product development and quality control. It involves the identification, quantification, and characterization of impurities present in drug substances and drug products…
Custom Synthesis of Impurity Standard Material
Impurity standard materials are critical tools in pharmaceutical analysis, enabling the accurate identification, quantification, and control of impurities in drug substances and drug products…
Challenges in HPLC Method Development for Impurity Identification
High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique for impurity identification and quantification in the pharmaceutical industry…
The Complexities of Pharmaceutical Impurity Characterization: Challenges and Solutions
Pharmaceutical impurity characterization is a critical aspect of ensuring the safety, efficacy, and quality of pharmaceutical products…
Working Standards vs. Reference Standards: Understanding the Key Differences
Pharmaceutical manufacturing is a complex process that requires a high level of precision and accuracy. Working standards and reference standards are two important terms that are used in this field…
Helpful Details While Sending an Enquiry of Impurity Standards – SynThink
Pharmaceutical impurity standards play a crucial role in ensuring the safety and efficacy of drugs. They are used as reference materials for the identification, quantification, and control of impurities in pharmaceutical products…
Genotoxic Impurities
Genotoxic impurities are substances that can cause damage to genetic material, including DNA, which can lead to mutations or cancer…