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

The name of Baclofen is β-(Aminomethyl)-4-chlorobenzenepropanoic acid. Its chemical formula is C₁₀H₁₂ClNO_2, 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.