Now Available | CATO Acyclovir EP Impurity R – Empowering Antiviral Drug Quality Control

Acyclovir, the first truly effective antiviral drug, was discovered and patented by GlaxoSmithKline in 1974, entered clinical trials in 1977, and was approved for medical use in 1981. As a nucleoside analog, acyclovir effectively blocks herpes virus replication by inhibiting viral DNA polymerase.

Acyclovir is a representative drug in the WHO Essential Medicines List and serves as one of the cornerstones of antiviral therapy. Its derivatives, including valacyclovir and penciclovir, have also been widely adopted in clinical practice.

Acyclovir EP Impurity R

Quality Research and the Importance of Impurity Control Focus on Acyclovir EP Impurity R

Product Name: Acyclovir EP Impurity R

Catalog No.: C4X-101018

Molecular Formula: C₁₇H₂₂N₁₀O₆

Molecular Weight: 462.42

With the advancement of generic drug bioequivalence evaluation and international registration submissions, the demand for reference standards of acyclovir and its related impurities (particularly EP impurities) continues to grow. The European Pharmacopoeia (EP) lists multiple acyclovir impurities (such as Impurity A, B, C, R, etc.), which are widely used in quality control for identification, quantitative analysis, and method development.

Among these, EP Impurity R, as a key structural analog, holds significant indicative value in stability and degradation pathway studies. The EP imposes strict limit requirements for this impurity, and its control level directly impacts product compliance and quality safety.

To support quality research and registration submissions, CATO's in-house developed Impurity R reference standard features high purity and high stability, complete with comprehensive Certificate of Analysis (COA), making it widely applicable for process optimization, method development, registration dossier preparation, and various other application requirements.

Furthermore, CATO not only develops multiple acyclovir-related impurities in-house but also continuously expands its API impurity reference standard library, covering multiple therapeutic areas including anti-infectives, oncology, and cardiovascular drugs. We support custom synthesis and method development, providing comprehensive one-stop impurity research solutions.

Please contact the CATO sales team for product details or related COA information.

E-mail：standards@cato-chem.com