Description

Oxybutynin Impurity A is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Oxybutynin. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Oxybutynin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in Oxybutynin under various stress conditions.
• Research & Development: Used in R&D labs for studying the metabolic pathways, degradation chemistry, and synthesis of Oxybutynin.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity.

Basic Information

Product Name	Oxybutynin Impurity A
CAS No.	1199574-71-4
Molecular Formula	C22H31NO3
Molecular Weight	357.49 g/mol
Synonyms	4-(Diethylamino)-2-butynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate; Oxybutynin Related Compound A; Oxybutynin EP Impurity A; Oxybutynin USP Impurity A; (RS)-Oxybutynin Impurity A; α-Cyclohexyl-α-hydroxybenzeneacetic acid 4-(diethylamino)-2-butynyl ester; Ditropan Impurity A
EINECS	Contact for details

Quality Control

Every batch of Oxybutynin Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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