Isosorbide Impurity NEW

Isosorbide Impurity；65940-93-4

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

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• Product Information

• Product Code：I028006

• English Name：Isosorbide Impurity 6

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

• CAS No.：65940-93-4

• Molecular Formula：C₈H₁₂O₅

• Molecular Weight：188.18

• 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-water mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 6 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 esterification temperature (e.g., 50-60℃) and catalyst dosage.

• 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, a bicyclic sugar alcohol, is used for treating glaucoma and cerebral edema by increasing plasma osmotic pressure. Impurity 6, a process-related impurity in Isosorbide synthesis, may originate from cyclization side reactions of sorbitol or incomplete esterification. Its hydroxyl and acetate groups may affect drug water solubility and stability. With stricter requirements for ophthalmic and CNS drug impurities, 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 5 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by acetylation of intermediates during Isosorbide cyclization from sorbitol under acidic catalyst (e.g., p-toluenesulfonic acid); optimizing catalyst type and reaction time reduces by-product generation.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 212.3 μM against ARPE-19 cells (Isosorbide IC₅₀=15.8 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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!