Description

Oxybutynin is a tertiary amine antimuscarinic agent, widely recognized for its antispasmodic properties. It is a critical active pharmaceutical ingredient (API) essential for the formulation of medications that treat overactive bladder and urinary incontinence. This compound is primarily utilized by pharmaceutical manufacturers and research institutions engaged in developing and producing urological therapeutics. Its reliable efficacy makes it a cornerstone in managing specific muscular hyperactivities.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for overactive bladder (OAB) syndrome, reducing symptoms of urinary urgency, frequency, and incontinence.
• Antispasmodic Formulations: Incorporated into drugs designed to relieve smooth muscle spasms in the bladder and gastrointestinal tract.
• Transdermal Patch Systems: Used in the development of controlled-release transdermal delivery systems to provide steady-state plasma levels and minimize systemic side effects.
• Pediatric & Geriatric Medications: Serves in the formulation of age-appropriate dosage forms, such as oral solutions or low-dose tablets, for specific patient populations.
• Generic Drug Manufacturing: A key component for companies producing bioequivalent generic versions of branded anticholinergic drugs.
• Clinical Research & Development: Employed as a reference standard or building block in pharmacological studies and the development of new urological treatments.

Basic Information

Product Name	Oxybutynin
CAS No.	5633-20-5
Molecular Formula	C22H31NO3
Molecular Weight	357.49 g/mol
Synonyms	Oxybutynin Chloride (Hydrochloride Salt); 4-(Diethylamino)-2-butynyl α-phenylcyclohexaneglycolate; Ditropan; Oxytrol; Trosec; Oxybutynin Hydrochloride; α-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester; DL-304
EINECS	227-077-6

Quality Control

Our Oxybutynin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including identity, assay, and impurity profile verification. Certificates of Analysis (COA) are provided with each shipment, detailing compliance with relevant in-house specifications. We support our partners with the documentation required for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to exclude moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.