MDS-06-03 is a high-purity analytical reference standard essential for pharmaceutical development and quality control. The molecule, with the formula C21H38O4S3 and a molecular weight of 450.72, features a multi-thioether containing ester structure. MDS-06-03 is supplied as a certified reference material for use in HPLC and UPLC method validation, specifically for solifenacin succinate impurity profiling. The availability of MDS-06-03 as a fully characterized standard ensures accurate quantification and identification of related substances in drug substances and finished dosage forms, supporting regulatory compliance for ANDA and NDA submissions. MDS-06-03 is crucial for pharmaceutical manufacturers seeking to meet ICH Q3A guidelines for impurity control, and MDS-06-03 is supplied with a comprehensive Certificate of Analysis detailing its purity, identification, and storage conditions.
|
Parameter |
Specification |
|
Product Name |
MDS-06-03 |
|
CAS Number |
3082361-50-7 |
|
Molecular Formula |
C₂₁H₃₈O₄S₃ |
|
Molecular Weight |
450.72 g/mol |
|
Purity (HPLC) |
≥95.0% |
|
Storage Condition |
-20°C |
When your solifenacin analytical program or ANDA filing demands a reliable impurity reference standard, Cosperpharm supplies MDS-06-03 with the documentation depth, supply transparency, and technical support that method validation scientists and regulatory specialists require.
Confidence starts with certified purity. MDS-06-03 undergoes rigorous HPLC purity verification with full chromatographic traceability. This ensures that the standard you receive is suitable for generating accurate relative retention times, system suitability parameters, and relative response factors — the foundational data for any stability-indicating method.
Documentation structured for regulatory review. Each shipment of MDS-06-03 is accompanied by a batch-specific Certificate of Analysis containing purity data, analytical traces, and residual solvent information, formatted for direct incorporation into your method validation report. DMF-ready documentation packages and long-term stability summaries are available upon request to streamline your submission.
Scalable supply with clear communication. Cosperpharm provides MDS-06-03 from milligram quantities for initial method scouting to larger batches for method transfer and validation across multiple sites. We confirm lead times at the point of inquiry, allowing you to plan your method development activities without supply-chain uncertainty.
Access to analytical expertise. Our team can provide guidance on the handling of MDS-06-03, recommended diluent selection, and approaches for establishing the standard as a reference marker in HPLC or UPLC systems — based on our experience supporting pharmaceutical impurity profiling campaigns.
Global delivery with predictable logistics. Cosperpharm ships MDS-06-03 to pharmaceutical manufacturers, CROs, and analytical laboratories internationally, with all customs documentation provided. Volume-appropriate packaging and upfront lead-time communication ensure your project timeline stays on track.
A: MDS-06-03 is a pharmaceutical impurity reference standard associated with solifenacin succinate, a medication for overactive bladder. It is used to detect and quantify a specific related substance during analytical testing and method validation.
A: MDS-06-03 is primarily applied as a reference marker in the development, validation, and routine execution of HPLC and UPLC methods for solifenacin succinate. It is integral to impurity profiling, forced degradation studies, and the preparation of ANDA regulatory submissions.
Cosperpharm applies a rigorous quality framework to every batch of MDS-06-03 to meet the demands of modern pharmaceutical analysis.
Comprehensive Characterization: Each batch undergoes HPLC purity determination (≥95%) alongside structural confirmation via techniques such as mass spectrometry and nuclear magnetic resonance spectroscopy. Full analytical data packages are maintained.
Batch Traceability: From sourcing through synthesis or isolation and final packaging, every step is documented. A unique lot number links all production and quality control records, and retention samples are preserved according to established procedures.
Commitment: Long-term and accelerated stability studies are conducted to monitor MDS-06-03 under its recommended storage conditions. Summaries of stability data are available to support the shelf-life justification 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, we can provide DMF-ready documentation and enter into custom quality agreements as needed.
Audit Accessibility: Qualified customers may schedule audits of Cosperpharm’s quality systems and facilities. Documentation related to ISO compliance can be provided upon request
Initiating an order for MDS-06-03 or requesting detailed technical documentation is a straightforward process with Cosperpharm.
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