Description

Penehyclidine Impurity 18 is a designated impurity standard used in the analytical profiling and quality control of the anticholinergic drug Penehyclidine Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine batch testing in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Penehyclidine Hydrochloride impurities.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in API batches.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers to establish specification limits and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process.

Basic Information

Product Name	Penehyclidine Impurity 18
CAS No.	63624-23-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Penehyclidine Related Compound 18; Penehyclidine HCl Impurity 18; 3-(2-Cyclopentyl-2-hydroxy-2-phenylacetoxy)quinuclidine (potential structural descriptor); Penehyclidine Process Impurity; Penehyclidine Degradant; Quinuclidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate derivative
EINECS	Contact for details

Quality Control

Every batch of Penehyclidine Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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