High‐Quality Atorvastatin Impurity Standards for Accurate Pharmaceutical Research - aquigenbio/blog GitHub Wiki

Atorvastatin is one of the most widely prescribed statins, primarily used to lower cholesterol and prevent cardiovascular diseases. As a crucial component in generic and branded formulations, atorvastatin must be tested with the highest standards of precision and accuracy. At Aquigen Bio, we offer an advanced range of atorvastatin impurity standards to support pharmaceutical development, quality control, and regulatory compliance.

Why Are Atorvastatin Impurity Standards Important? In drug development and production, the identification and quantification of impurities play a critical role in ensuring safety, efficacy, and compliance with international guidelines such as ICH and FDA. Impurity profiling of atorvastatin helps manufacturers meet stringent quality requirements, providing confidence in the drug’s therapeutic effectiveness.

Aquigen Bio’s impurity standards are synthesized and characterized with high purity and traceability, ensuring accurate results in analytical testing.

Explore Our Range of Atorvastatin Impurity Standards Our collection of atorvastatin-related impurity standards includes rare and stable isotope-labeled compounds to support bioanalytical and pharmacokinetic studies.

  1. (3R,5S)-Atorvastatin Calcium salt This stereospecific calcium salt form of atorvastatin plays a critical role in chiral impurity testing and stereoisomer profiling. Its precise structure helps ensure the enantiomeric purity of the active pharmaceutical ingredient (API).

  2. 2-Hydroxy Atorvastatin D5 This deuterated metabolite is valuable in mass spectrometry applications. The presence of five deuterium atoms enhances sensitivity and precision in LC-MS/MS quantification, making it an ideal internal standard in pharmacokinetic and metabolic stability studies.

  3. 2-Hydroxy Atorvastatin D5 Disodium Salt The disodium salt form improves solubility and stability, offering a reliable reference standard for bioavailability and dissolution testing. It’s especially useful in developing robust analytical methods for complex matrices.

Why Choose Aquigen Bio? Aquigen Bio stands out as a trusted partner for high-purity impurity standards. Here’s what makes us different:

GMP-compliant synthesis Certificate of Analysis (CoA) with detailed characterization data Global shipping with temperature-controlled logistics Customized solutions for R&D and commercial needs Whether you’re developing a generic atorvastatin formulation or optimizing quality control processes, our range of impurity standards supports every stage of pharmaceutical analysis.