Description

Oxybutynin Impurity C 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, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Oxybutynin Impurity C in Oxybutynin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating analytical methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Oxybutynin drug substances and products meet ICH, USP, or EP impurity limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Serves as a critical tool in pharmaceutical R&D for studying the degradation pathways and chemistry of Oxybutynin.

Basic Information

Product Name	Oxybutynin Impurity C
CAS No.	1199574-70-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oxybutynin Related Compound C; Oxybutynin EP Impurity C; Oxybutynin USP Impurity C; 4-(Diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate Impurity; (RS)-4-(Diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Impurity; Degradation Product of Oxybutynin; Oxybutynin Degradant C
EINECS	Contact for details

Quality Control

Our Oxybutynin Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with major pharmacopeial standards (USP, EP, ICH Q3B) and certificates are available upon request for regulatory documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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