Pregabalin

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(R)-3-(2-amino-2-oxoethyl)-5-methylhexanoic acid

  • CAT NUMBER DCTI-C-1300
  • CAS NUMBER 181289-33-8
  • MOLECULAR FORMULA C9H17NO3
  • MOLECULAR WEIGHT 187.24

(R)-3-(2-methoxy-2-oxoethyl)-5-methylhexanoic acid

  • CAT NUMBER DCTI-C-298
  • CAS NUMBER 156048-92-9
  • MOLECULAR FORMULA C10H18O4
  • MOLECULAR WEIGHT 202.25

(R)-isopropyl 2-hydroxy-2-phenyl-acetate

  • CAT Number DCTI-C-1669
  • CAS Number 89015-27-0
  • Molecular Formula C11H14O3
  • Molecular Weight 194.23

(S)-3-(2-Methoxy-2-oxoethyl)-5-methylhexanoic acid

  • CAT NUMBER DCTI-C-926
  • CAS NUMBER 181289-25-8
  • MOLECULAR FORMULA C10H18O4
  • MOLECULAR WEIGHT 202.25

(S)-isopropyl 2-hydroxy-2-phenyl-acetate

  • CAT Number DCTI-C-1668
  • CAS Number 53439-96-6
  • Molecular Formula C11H14O3
  • Molecular Weight 194.23

2,5-Bis(Pregabalin)-1,4-Benzoquinone

  • CAT NUMBER DCTI-C-2977
  • CAS NUMBER NA
  • MOLECULAR FORMULA C22H34N2O6
  • MOLECULAR WEIGHT 422.52

3-(2-amino-2-oxoethyl)-5-methylhexanoic acid

  • CAT NUMBER DCTI-C-852
  • CAS NUMBER 181289-15-6
  • MOLECULAR FORMULA C9H17NO3
  • MOLECULAR WEIGHT 187.24

3-(aminomethyl)-5-methylhex-4-enoic acid

  • CAT NUMBER DCTI-C-223
  • CAS NUMBER 216576-74-8
  • MOLECULAR FORMULA C8H15NO2
  • MOLECULAR WEIGHT 157.21

3-(aminomethyl)-5-methylhex-5-enoic acid

  • CAT NUMBER DCTI-C-224
  • CAS NUMBER 1136478-30-2
  • MOLECULAR FORMULA C8H15NO2
  • MOLECULAR WEIGHT 157.21
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General Information

Pregabalin Impurities and Pregabalin 

Daicel Pharma synthesizes high-quality Pregabalin impurities, (S)-isopropyl 2-hydroxy-2-phenyl-acetate, (R)-isopropyl 2-hydroxy-2-phenyl-acetate, 3-(aminomethyl)-5-methylhex-5-enoic acid, dimethyl 3-isobutylpentanedioate, and more, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Pregabalin. Moreover, Daicel Pharma offers custom synthesis of Pregabalin impurities and delivers them globally.

Pregabalin [CAS: 148553-50-8] is a 3-isobutyl derivative of the neurotransmitter γ-aminobutyric acid. It has anticonvulsant properties. Pregabalin helps prevent seizures, reduces anxiety, and relieves pain. It also treats painful neuropathy and epilepsy.

Pregabalin: Use and Commercial Availability  

Pregabalin treats neuropathic pain and seizures. It is available under the brand names LYRICA and LYRICA CR. It treats neuropathic pain associated with diabetic peripheral neuropathy, spinal cord injury, postherpetic neuralgia, and fibromyalgia. It also acts as an adjunctive therapy for partial-onset seizures in adults with epilepsy.

Pregabalin Structure and Mechanism of ActionPregabalin Structure and Mechanism of Action 

The chemical name of Pregabalin is (3S)-3-(Aminomethyl)-5-methylhexanoic acid. Its chemical formula is C8H17NO2, and its molecular weight is approximately 159.23 g/mol.

Pregabalin binds with the alpha2-delta site of presynaptic voltage-dependent calcium channels in central nervous system tissues.

Pregabalin Impurities and Synthesis

Impurities may form during the manufacturing1, storage, or usage of Pregabalin. They include related substances, residual solvents, and degradation products. Some of these impurities may be toxic and impact the drug’s quality, safety, and efficacy. Therefore, it is essential to monitor and control the impurities in Pregabalin through analytical methods and proper storage conditions.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Pregabalin impurity standards, (S)-isopropyl 2-hydroxy-2-phenyl-acetate, (R)-isopropyl 2-hydroxy-2-phenyl-acetate, 3-(aminomethyl)-5-methylhex-5-enoic acid, dimethyl 3-isobutylpentanedioate, and more. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We also provide 13C-DEPT and CHN on request. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Pregabalin impurity or degradation product.

References
FAQ's

Frequently Asked Questions

Impurity profiling is essential in identifying and controlling impurities in Pregabalin during manufacturing.

Various analytical methods like High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-mass spectroscopy (LC-MS), etc., help identify impurities in Pregabalin.

Methanol or Acetonitrile is the solvent used for analyzing many impurities in Pregabalin.

Pregabalin impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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