Pregabalin Impurity 62;1511511-44-6

Product Information

• Product Code: P006062

• English Name: Pregabalin Impurity 62

• English Alias: 2-(4-isobutyl-2-oxopyrrolidin-1-yl)acetic acid

• CAS No.：1511511-44-6

• Molecular Formula: C??H??NO?

• Molecular Weight: 199.25

Advantages

• High-Purity Reference Standard: As a reference standard for Pregabalin Impurity 62, its structure is confirmed by NMR and MS with ≥98.5% purity (HPLC), suitable for pharmaceutical impurity analysis and quality control.

• Good Stability: Stored at 2-8°C in the dark, it has a shelf life of 24 months, with <1% degradation per month in solution (e.g., methanol), ensuring reliable detection data.

Applications

• Impurity Detection: Used for HPLC/LC-MS detection of Impurity 62 in Pregabalin API and formulations, controlling impurity content ≤0.1% (refer to ICH Q3A).

• Process Optimization: In Pregabalin synthesis, monitor the generation of this impurity during the cyclization stage, reducing its content to below 0.05% by adjusting reaction pH (controlled at 8.0-8.5) and temperature (≤50℃).

• Stability Studies: As a degradation product standard in acid/alkali stress tests, validates method specificity and evaluates drug degradation pathways in pH 1.2/6.8 buffers.

Background Description

Research Status

• Detection Technology: UPLC-MS/MS is used with a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution, completing separation within 1.2 minutes with a detection limit of 0.008 ng/mL, 5 times more efficient than traditional HPLC.

• Formation Mechanism: Mainly originates from the substitution reaction of 4-isobutyl-2-pyrrolidinone with chloroacetic acid, promoted by excessive raw materials or prolonged reaction time. Using potassium carbonate as a base and controlling reaction time within 3 hours reduces impurity content from 0.7% to 0.03%.

• Safety Evaluation: In vitro experiments show an IC50 of 50μM on SH-SY5Y cells (Pregabalin API: 200μM), indicating low potential neurotoxicity, but EMA still sets its permissible daily exposure (PDE) ≤3μg, leading to a regulatory limit of ≤0.1% in drug standards.

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E-mail: anna@molcoo.com

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 17320513646
E-mail: anna@molcoo.com

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