MDS-06-06

MDS-06-06 is a high-purity pharmaceutical impurity reference standard utilized in the development and validation of analytical methods for solifenacin succinate. As a structurally distinct isomer sharing the same molecular formula (C₂₁H₃₈O₄S₃) as other solifenacin-related impurities, MDS-06-06 requires careful chromatographic separation and unambiguous identification during impurity profiling studies. The availability of MDS-06-06 as a certified reference standard enables analytical laboratories to establish accurate relative retention times, verify method specificity, and ensure that all isomeric impurity forms are properly resolved and quantified. Pharmaceutical manufacturers rely on MDS-06-06 to fulfill the selectivity and accuracy requirements mandated by ICH Q3A guidelines for ANDA regulatory submissions.

Product Parameters

Product Quality Assurance

Cosperpharm maintains a rigorous quality framework for MDS-06-06 designed to meet the expectations of modern pharmaceutical analytical development.

Thorough Characterization: Each batch of MDS-06-06 undergoes HPLC purity determination (≥95%) along with structural confirmation via appropriate analytical techniques. Given its isomeric relationship to other solifenacin impurities, particular attention is paid to identity confirmation and chromatographic specificity. Full analytical data packages are maintained for every batch produced.

Complete Batch Traceability: From raw material procurement through final packaging, every step is fully documented. A unique lot number links all production and quality control records, and retention samples are preserved in accordance with established procedures.

Stability Commitment: Stability studies are conducted under recommended storage conditions to monitor MDS-06-06 integrity over time. Stability data summaries are available to support the shelf-life justification required in regulatory dossiers.

Regulatory-Ready Documentation: A Certificate of Analysis and Safety Data Sheet accompany each shipment. For clients preparing solifenacin succinate ANDA or NDA submissions, Cosperpharm can provide DMF-ready documentation packages and enter into custom quality agreements as needed.

Audit Accessibility: Qualified customers may schedule audits of Cosperpharm's quality systems and facilities. ISO compliance documentation can be made available upon request.

Storage Conditions

Store MDS-06-06 at 2–8°C in a tightly sealed container, protected from light and moisture at all times. Allow the sealed package to equilibrate to ambient temperature before opening to prevent moisture condensation. Adherence to the storage recommendations specified in the Certificate of Analysis is essential for maintaining product integrity throughout its documented shelf life.

FAQ

Q1: How does MDS-06-06 differ from other solifenacin impurities with the same molecular formula?

A: MDS-06-06 shares the molecular formula C₂₁H₃₈O₄S₃ (molecular weight 450.72 g/mol) with other solifenacin-related impurities but differs in the connectivity or spatial arrangement of atoms within the molecule. This structural isomerism results in distinct chromatographic retention behavior, making individual reference standards essential for accurate identification and quantification.

Q2: What purity level does Cosperpharm supply for MDS-06-06?

A: Cosperpharm supplies MDS-06-06 with a purity of ≥95% as determined by HPLC. A batch-specific Certificate of Analysis containing full characterization data is provided with every order.

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Cosperpharm — Providing High-Purity Reference Standards for Rigorous Pharmaceutical Analysis.