Fesoterodine Impurities
General Information
Fesoterodine Impurities and Fesoterodine
Daicel Pharma specializes in synthesizing impurities for Fesoterodine, an active pharmaceutical ingredient. We offer crucial Fesoterodine impurities such as Fesoterodine Diol Dimer Fumarate, Fesoterodine Diol Dimer Monoester, and Fesoterodine Impurity P, which play a vital role in evaluating the purity, and safety of Fesoterodine. Daicel Pharma also provides custom synthesis of Fesoterodine impurities to meet specific client needs, and we offer worldwide delivery options.
As a medication to treat urinary incontinence and overactive bladder syndrome, Fesoterodine [CAS: 286930-02-7] has muscle relaxant and urinary antispasmodic properties. It functions as a competitive muscarinic receptor antagonist and an anticholinergic and antispasmodic agent.
Fesoterodine: Use and Commercial Availability
Fesoterodine, sold under the brand name Toviaz, is for adults experiencing symptoms of overactive bladders, such as urinary incontinence, urgency, and frequency. It also prevents a sudden lack of control over urination in patients.
Fesoterodine Structure and Mechanism of Action 
The chemical name of Fesoterodine is (R)-2-(3-Diisopropylamino-1-phenylpropyl)-4-hydroxymethyl phenyl isobutyrate. Its chemical formula is C26H37NO3, and its molecular weight is approximately 411.6 g/mol.
Fesoterodine hydrolyses its active metabolite, 5-hydroxymethyl tolterodine, which prevents bladder contractions caused by acetylcholine. It relaxes the bladder’s smooth muscle and reduces the involuntary loss of urine.
Fesoterodine Impurities and Synthesis
Impurities in Fesoterodine refer to unintended substances that may be present alongside the active pharmaceutical ingredient. They can arise during the manufacturing process1, storage, or due to interactions with other components. Analytical methods like chromatography and spectroscopy help identify and quantify these impurities. Strict quality control measures during production help minimize impurity formation and ensure product safety and efficacy. Regulatory guidelines provide limits and specifications for the acceptable levels of impurities in Fesoterodine. Ongoing monitoring and analysis help maintain the quality and purity of Fesoterodine, ensuring its effectiveness as a medication.
Daicel Pharma, in adherence to cGMP standards, operates an analytical facility where we prepare Fesoterodine impurity standards like Fesoterodine Diol Dimer Fumarate, Fesoterodine Diol Dimer Monoester, and Fesoterodine Impurity P. We offer a comprehensive Certificate of Analysis (CoA) for these impurities, providing a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis2. Upon request, we provide additional data like 13C-DEPT. We can synthesize unknown Fesoterodine impurities or degradation products. Every delivery has a comprehensive characterization report.
References
FAQ's
References
- Meese, Claus, Stable Salts of Novel Derivatives Of 3,3-Diphenylpropylamines, Schwarz Pharma A.-G., Germany, EP1230209B1, January 12, 2005
- Sangoi, Maximiliano S.; Steppe, Martin, Determination of Fesoterodine in pharmaceutical formulations by using liquid chromatography-tandem mass spectrometry, European Journal of Mass Spectrometry, Volume: 16, Issue: 6, Pages: 653-661, 2010
Frequently Asked Questions
How are impurities controlled during the manufacturing of Fesoterodine?
Strict quality control measures, including adherence to Good Manufacturing Practices (GMP), are implemented during the manufacturing process of Fesoterodine to minimize impurity formation and ensure product quality and safety.
How often are Fesoterodine formulations tested for impurities?
Fesoterodine formulations undergo regular testing throughout the manufacturing process and during stability studies to monitor impurity levels and ensure compliance with regulatory requirements.
What are the potential risks of having high levels of Fesoterodine impurities?
The high levels of Fesoterodine impurities can pose risks such as reduced drug efficacy, increased toxicity, potential adverse effects, and compromised patient safety.
How should Fesoterodine impurities be stored in terms of temperature?
For proper storage of Fesoterodine impurities, the advice is to keep them at a controlled room temperature, ranging from 2-8 °C. However, the storage of specific impurities like Fesoterodine Impurity P should be at temperatures below -20 °C, as indicated in the Certificate of Analysis (COA).
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