MDS-08-01

MDS-08-01 is an amphiphilic lipid-like impurity reference standard chemically identified as 4-nonanoyloxy-3-(nonanoyloxymethyl)butanoic acid. The molecule's dual ester linkages suggest that MDS-08-01 may arise as a process-related impurity during API synthesis involving acylation steps with nonanoic acid derivatives, or potentially as a degradation product in formulations containing lipid-based excipients. Given its surfactant-like character, MDS-08-01 serves as a critical marker for monitoring the formation of higher-molecular-weight impurities that may affect drug substance purity and chromatographic performance. The availability of MDS-08-01 as a certified reference material enables analytical laboratories to validate HPLC methods capable of resolving and quantifying this specific impurity, supporting compliance with ICH Q3A guidelines for pharmaceutical development.

Product Parameters

Product Advantages

1.Structurally Distinctive Marker for Lipid-Related Impurity Profiling

MDS-08-01 serves as a dedicated reference standard for identifying and quantifying a specific process-related impurity featuring dual nonanoyloxy ester chains and a free carboxylic acid group. Its availability as a fully characterized standard is essential for establishing method specificity and ensuring accurate impurity determination in pharmaceutical products involving lipid-based synthetic intermediates.

2.High-Purity Certified Reference Material

Supplied with a purity specification appropriate for reference standard use, each batch of MDS-08-01 is characterized using appropriate analytical techniques, including mass spectrometry and NMR spectroscopy, to confirm both identity and purity. A comprehensive Certificate of Analysis provides the documentation required for qualification as a reference standard in regulated GMP analytical environments.

3.Key Component for Process-Related Impurity Monitoring

MDS-08-01 is employed during process development and validation to monitor the formation of acylation-related impurities. Its well-defined chromatographic behavior helps establish that the manufacturing process adequately controls the levels of this specific impurity, supporting process validation and regulatory acceptance.

4.Supporting Comprehensive Regulatory Submissions

For manufacturers filing ANDA or NDA submissions, MDS-08-01 serves as a required impurity reference standard during analytical method validation. Its use covers critical parameters such as system suitability, specificity, accuracy, precision, and robustness in accordance with ICH Q2(R1) guidelines.

5.Enabling Routine Quality Control and Batch Release

Once validated, methods that employ MDS-08-01 are applied to the routine testing of commercial production batches, ensuring that impurity levels remain within established acceptance criteria and supporting consistent product quality throughout the product lifecycle.

Storage Conditions

Store MDS-08-01 powder at -20°C in a tightly sealed container, protected from light and moisture at all times. The product can be stored for up to 24 months under these conditions. Allow the sealed package to equilibrate to ambient temperature for at least one hour before opening to prevent moisture condensation. For solutions, DMSO stocks may be stored at -80°C for up to 6 months; however, it is recommended to prepare and use solutions on the same day wherever possible. The compound's ester linkages are susceptible to hydrolysis; therefore, storage under an inert atmosphere (argon or nitrogen) is strongly recommended. Adherence to the storage recommendations specified in the Certificate of Analysis is essential for maintaining product integrity.

Product Quality Assurance

Cosperpharm maintains a rigorous quality framework for MDS-08-01 designed to meet the demands of modern pharmaceutical analytical development.

Thorough Characterization: Each batch of MDS-08-01 undergoes HPLC purity determination along with structural identity confirmation via mass spectrometry and NMR spectroscopy. 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 (-20°C powder; -80°C for DMSO solutions) to monitor MDS-08-01 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 regulatory 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.

Environmental Responsibility: Cosperpharm acknowledges the environmental hazard classification of MDS-08-01 (H410: Very toxic to aquatic life with long lasting effects) and ensures that all handling, packaging, and disposal recommendations are clearly communicated to customers to minimize environmental impact.

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