Isosorbide Impurity；39698-15-2

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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• Product Information

• Product Code：I028007

• English Name：Isosorbide Impurity 7

• English Alias：(3R,3aR,6S,6aS)-6-(nitrooxy)hexahydrofuro[3,2-b]furan-3-yl acetate

• CAS No.：39698-15-2

• Molecular Formula：C?H??NO?

• Molecular Weight：233.18

• Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Isosorbide impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 7 in Isosorbide API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Isosorbide synthesis, reducing generation by >30% by adjusting nitration temperature (e.g., 0-5℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

• Background Description

• Isosorbide, an osmotic diuretic used for treating glaucoma and cerebral edema, acts by increasing plasma osmotic pressure. Impurity 7, a nitrooxy-related impurity in Isosorbide synthesis, may originate from nitration side reactions or raw material residues. Its nitrooxy and acetate groups may affect drug stability, osmotic regulation, and safety. Due to strict impurity control requirements for ophthalmic and CNS drugs, studying this impurity is crucial for ensuring drug quality.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nitration of Isosorbide intermediates in nitric acid-acetic acid systems; optimizing nitric acid concentration and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 175.6 μM against ARPE-19 cells (Isosorbide IC??=12.3 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity conditions.

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NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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