MDS-06-01

MDS-06-01 is a branched alkanethiol impurity reference standard chemically identified as 2-propyl-1-heptanethiol. The presence of the reactive thiol group in MDS-06-01 suggests that it may arise as a process-related impurity in drug substances where thiol-containing reagents or intermediates are utilized, or potentially as a degradation product formed through the cleavage of thioether linkages under stressed storage conditions. The nucleophilic character of the thiol moiety in MDS-06-01 also makes it a potential reactive impurity that can participate in disulfide exchange reactions or form adducts with electrophilic functional groups present in the active pharmaceutical ingredient or excipients. Given these reactivity considerations, MDS-06-01 serves as a critical marker for monitoring sulfur-containing impurities that may affect drug substance purity, stability, and safety profiles. The availability of MDS-06-01 as a certified reference material enables analytical laboratories to validate HPLC and GC methods capable of detecting and quantifying this specific branched thiol impurity, supporting compliance with ICH Q3A guidelines for the control of organic impurities in pharmaceutical products.

Product Parameters

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FAQ

Q1: What purity level does Cosperpharm supply for MDS-06-01?

A: Cosperpharm supplies MDS-06-01 with a purity of ≥95% as determined by GC or HPLC. A batch-specific Certificate of Analysis containing full characterization data accompanies every order.

Q2:What documentation is provided with a shipment of MDS-06-01?

A: Each shipment includes a Certificate of Analysis (COA) with purity data, analytical chromatograms, and a Material Safety Data Sheet (MSDS). DMF-ready documentation packages and tailored quality agreements can be arranged to support regulatory submissions.

Storage Conditions

Store MDS-06-01 at 2–8°C in a tightly sealed container under an inert atmosphere of nitrogen or argon. The compound should be protected from light and moisture at all times. Allow the sealed package to equilibrate to ambient temperature before opening to prevent moisture condensation. The terminal thiol group is susceptible to oxidative dimerization to the corresponding disulfide; therefore, storage under inert gas is essential for maintaining product integrity. Under recommended storage conditions, the compound is stable; however, prolonged exposure to air, oxidizing agents, or elevated temperatures should be avoided. Adherence to the storage recommendations specified in the Certificate of Analysis is essential for preserving product quality throughout its documented shelf life.

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