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Postion:Product Catalog >Pregabalin Impurity 63
Pregabalin Impurity 63
  • Pregabalin Impurity 63
  • Pregabalin Impurity 63
  • Pregabalin Impurity 63
  • Pregabalin Impurity 63
  • Pregabalin Impurity 63

Pregabalin Impurity 63 NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-31

Product Details

Product Name: Pregabalin Impurity 63 CAS No.: 181289-16-7
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/31
Molecular Formula: C8H13NO2

Pregabalin Impurity;181289-16-7

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


  • Product Information

  • Product Code:P006063

  • English Name:Pregabalin Impurity 63

  • English Alias:3-cyano-5-methylhexanoic acid

  • CAS No.:181289-16-7

  • Molecular Formula:C?H??NO?

  • Molecular Weight:155.19

  • Advantages

  • High-Purity Guarantee:Confirmed by HPLC (≥99.0%) and verified by multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing a reliable standard for Pregabalin impurity analysis.

  • Excellent Stability:Stable for 36 months under storage conditions of -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in common solvent systems such as methanol - water, ensuring stable and repeatable experimental data.

  • Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 63 in Pregabalin API and formulations. Strictly control the impurity content to meet ICH Q3A standards (single impurity limit ≤0.1%), ensuring drug quality and safety.

  • Process Optimization Research:Monitor the formation pathway of this impurity during the synthesis of Pregabalin. By adjusting parameters such as cyanidation reaction temperature (e.g., 40 - 50℃), reaction time, and reactant ratio, the generation of impurities can be reduced by more than 35%.

  • Method Validation:As a standard for developing impurity detection methods, it can verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC, ensuring the accuracy and sensitivity of the detection method.

  • Background Description

  • Pregabalin, a γ-aminobutyric acid (GABA) analog, is mainly used to treat postherpetic neuralgia, partial-onset epilepsy, and generalized anxiety disorder. It works by regulating voltage-gated calcium channels in the central nervous system to reduce neurotransmitter release. Impurity 63, a process-related impurity in Pregabalin synthesis, may originate from cyanidation or alkylation side reactions of intermediates. Its cyano and carboxyl groups may affect drug chemical stability, biological activity, and safety. Given the extremely strict impurity control requirements for nervous system drugs, the study of this impurity is crucial for ensuring the quality of Pregabalin drugs.
  • Research Status

  • Detection Technology:UPLC-MS/MS technology is used, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile. Impurities can be separated within 5 minutes, and the limit of detection is as low as 0.003 ng/mL, enabling high-precision detection of trace impurities.

  • Formation Mechanism:Studies have shown that this impurity is formed by the reaction of 5-methylhexanoic acid with cyanide reagents under the action of an alkaline catalyst (such as sodium carbonate). Optimizing the catalyst dosage and reaction pH can effectively inhibit side reactions.

  • Safety Evaluation:In vitro cytotoxicity experiments show that the IC?? of this impurity against SH-SY5Y nerve cells is 186.7 μM (Pregabalin IC?? = 12.5 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to systematically study its degradation characteristics under high temperature, high humidity, and light conditions.

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! 





Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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