MDS-06-03 is a high-purity pharmaceutical impurity reference standard utilized in the development and validation of analytical methods for solifenacin succinate, a muscarinic M₃ receptor antagonist indicated for overactive bladder syndrome. As a structurally characterized related substance, MDS-06-03 enables the accurate identification and quantification of this specific impurity during forced degradation studies, process development, and routine quality control testing. The availability of MDS-06-03 as a certified reference material ensures that analytical laboratories can establish reliable relative retention times and response factors, supporting compliance with ICH Q3A guidelines for the control of organic impurities in pharmaceutical products. Pharmaceutical manufacturers and generic drug developers rely on MDS-06-03 to meet the specificity and sensitivity requirements mandated for ANDA regulatory submissions.
|
Parameter |
Specification |
|
Product Name |
MDS-06-03 |
|
CAS Number |
1373514-32-9 |
|
Molecular Formula |
C₇H₁₂O₃S₂ |
|
Molecular Weight |
208.3 g/mol |
|
Purity (HPLC) |
≥95.0% |
|
Storage Condition |
2–8°C |
MDS-06-03 serves as a dedicated reference standard for identifying and quantifying a specific process-related impurity or degradation product in solifenacin succinate drug substance and finished dosage forms. Its availability as a fully characterized standard is essential for establishing method specificity and ensuring accurate impurity determination.
Supplied with a minimum HPLC purity of 95%, each batch of MDS-06-03 is characterized using appropriate analytical techniques to confirm identity and purity. A comprehensive Certificate of Analysis provides the documentation required for qualification as a reference standard in regulated analytical environments.
MDS-06-03 is employed in forced degradation studies to verify the stability-indicating power of analytical methods under oxidative, thermal, photolytic, and hydrolytic stress conditions. Its chromatographic behavior helps demonstrate that the method can effectively resolve degradation products from the active pharmaceutical ingredient.
For generic manufacturers filing Abbreviated New Drug Applications for solifenacin succinate, MDS-06-03 serves as an impurity reference standard during analytical method validation, covering parameters such as system suitability, specificity, accuracy, precision, and robustness in accordance with ICH Q2(R1).
Once validated, methods that employ MDS-06-03 are applied to the routine testing of commercial production batches, ensuring impurity levels remain within established acceptance criteria and supporting consistent product quality throughout the product lifecycle.
A: MDS-06-03 should be stored at 2–8°C in a tightly sealed container, protected from light and moisture. Detailed storage instructions are provided in the Certificate of Analysis accompanying each shipment.
A: Reference standard quantities are generally shipped within 5–10 business days, subject to current inventory status. Exact lead times are confirmed at the time of quotation to support project scheduling.
MDS-06-03 is utilized as a reference standard to identify and quantify specific related substances during the release testing of solifenacin succinate active pharmaceutical ingredient and finished dosage forms.
Included as a marker compound in forced degradation studies conducted under oxidative, thermal, photolytic, and hydrolytic stress conditions to establish the stability-indicating capability of HPLC/UPLC analytical methods.
Serves as a required impurity reference standard within analytical method validation packages submitted in Abbreviated New Drug Applications for generic solifenacin succinate products.
Employed by QC laboratories to accurately quantify specified and unspecified impurities in commercial solifenacin batches, supporting compliance with pharmacopeial and ICH limits.
Supports the determination of specificity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, and robustness during method validation and successful transfer between laboratories.
Monitored during formulation development to assess potential degradation pathways and confirm the chemical compatibility of selected excipients with the active pharmaceutical ingredient.
Initiating an order for MDS-06-03 or requesting detailed technical documentation is a straightforward process with Cosperpharm.
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