Description

Penehyclidine Impurity 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) penehyclidine hydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Penehyclidine Hydrochloride API and its formulations.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in penehyclidine-based drug products under various stress conditions.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Chemical Research and Synthesis: Acts as an intermediate or a building block in advanced organic synthesis and process chemistry research.
• Quality Control and Assurance: Provides a benchmark for in-house quality control testing to ensure batch-to-batch consistency and purity of the final drug substance.

Basic Information

Product Name	Penehyclidine Impurity
CAS No.	110480-94-9
Molecular Formula	C20H29NO3
Molecular Weight	331.45 g/mol
Synonyms	Penehyclidine Related Compound; 3-(2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)quinuclidine; Quinuclidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate; Penehyclidine EP Impurity; Penehyclidine Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Penehyclidine Impurity CAS NO 110480-94-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect this light-sensitive material from prolonged exposure.

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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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