Baclofen

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(R)-Baclofen Hydrochloride

  • CAT Number DCTI-A-184
  • CAS Number 63701-55-3
  • Molecular Formula C10H13Cl2NO2 (HCl Salt) C10H12ClNO2 (Free base)
  • Molecular Weight 250.12 (HCl Salt) 213.66 (Free base)

(S)-Baclofen Hydrochloride

  • CAT Number DCTI-A-185
  • CAS Number 63701-56-4
  • Molecular Formula C10H13Cl2NO2 (HCl Salt) C10H12ClNO2 (Free base)
  • Molecular Weight 250.12 (HCl Salt) 213.66 (Free base)

Baclofen butyl ester HCl

  • CAT NUMBER DCTI-C-1881
  • CAS NUMBER 947583-11-1
  • MOLECULAR FORMULA C14H20ClNO2 (Free base) C14H21Cl2NO2 (HCl salt)
  • MOLECULAR WEIGHT 269.77 (Free base) 306.23 (HCl salt)

Baclofen impurity 4

  • CAT NUMBER DCTI-C-1882
  • CAS NUMBER 2414257-07-9
  • MOLECULAR FORMULA C16H16ClNO7
  • MOLECULAR WEIGHT 369.75

Diethyl 2-(4-chlorophenyl)-4-hydroxy-4-methyl-6-ox...

  • CAT Number DCTI-C-1025
  • CAS Number 294194-13-1
  • Molecular Formula C19H23ClO6
  • Molecular Weight 382.84

R-Baclofen – D4

  • CAT Number DCTI-A-186
  • CAS Number 69308-37-8 (Unlabelled)
  • Molecular Formula C10H9D4Cl2NO2 (HCl Salt) C10H8D4ClNO2 (Free base)
  • Molecular Weight 254.14 (HCl Salt) 217.69 (Free base)

S-Baclofen – D4

  • CAT Number DCTI-A-187
  • CAS Number 66514-99-6 (Unlabelled)
  • Molecular Formula C10H9D4Cl2NO2 (HCl Salt) C10H8D4ClNO2 (Free base)
  • Molecular Weight 254.14 (HCl Salt) 217.69 (Free base)

General Information

Baclofen Impurities and Baclofen  

Daicel Pharma provides high-quality Baclofen impurities, including (R)-Baclofen Hydrochloride, (S)-Baclofen Hydrochloride, Baclofen butyl ester HCl, Baclofen impurity 4, and Diethyl 2-(4-chlorophenyl)-4-hydroxy-4-methyl-6-oxocyclohexane-1,3-dicarboxylate. These impurities are essential for evaluating the quality, stability, and safety of Baclofen, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Baclofen impurities for global delivery to meet the specific needs of our customers.

Baclofen [CAS: 1134-47-0] is a muscle relaxant primarily used to manage spasticity in individuals with multiple sclerosis. It is a synthetic chlorophenyl-butanoic acid derivative and functions by acting as a GABA agonist, specifically targeting GABA-B receptors.

Baclofen: Use and Commercial Availability  

Baclofen impurities can form during manufacturing, storage, or transportation affecting the drug’s quality, safety, and efficacy. Some Baclofen impurities include related compounds, degradation products, and residual solvents. These impurities can be toxic, affect the drug’s stability, or alter its pharmacokinetics. So it is necessary to control and monitor their levels to ensure their quality and safety for patient use.

Baclofen Structure and Mechanism of Action Baclofen Structure and Mechanism of Action

The name of Baclofen is β-(Aminomethyl)-4-chlorobenzenepropanoic acid. Its chemical formula is C10H12ClNO2, and its molecular weight is approximately 213.66 g/mol.

Baclofen inhibits monosynaptic and polysynaptic spinal reflexes. However, the exact mechanism of action is unknown.

Baclofen Impurities and Synthesis

Baclofen impurities can form during the manufacturing process, storage, or transportation, and they can affect the drug’s quality, safety, and efficacy. Some common impurities found in Baclofen include related compounds, degradation products, and residual solvents. These impurities can be toxic, affect the drug’s stability, or alter its pharmacokinetics. So it is necessary to control and monitor the levels of impurities in Baclofen to ensure its quality and safety for patient use.

Daicel Pharma offers a Certificate of Analysis (CoA) for Baclofen impurity standards, which includes (R)-Baclofen Hydrochloride, (S)-Baclofen Hydrochloride, Baclofen butyl ester HCl, Baclofen impurity 4, and Diethyl 2-(4-chlorophenyl)-4-hydroxy-4-methyl-6-oxocyclohexane-1,3-dicarboxylate. The CoA is produced from a cGMP-compliant analytical facility and includes comprehensive characterization data1, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additional characterization data, such as 13C-DEPT and CHN, can also be provided on request. Daicel Pharma can create unknown Baclofen impurities or degradation products and supply labeled compounds to evaluate the effectiveness of Baclofen. Further, Daicel Pharma offers R-Baclofen – D4 and S-Baclofen – D4, deuterium-labeled Baclofen compounds useful in bio-analytical research, such as BA/BE studies. Each delivery has a complete characterization report.

References
FAQ's

Frequently Asked Questions

Not all Baclofen impurities are harmful to health, but their presence can affect the quality and purity of the drug product, and some may pose a risk to patient health.

Complete elimination of impurities in Baclofen is not possible. However, a reduction in their levels to acceptable limits is through purification and quality control procedures.

The quality of Baclofen can be ensured during storage and transportation by following proper storage conditions such as temperature and humidity control and using appropriate packaging materials.

Baclofen impurities are stored at a controlled room temperature between 2-8 °C 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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