Description

Glycopyrrolate Impurity 12 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Glycopyrrolate. This compound, with the CAS number 857353-41-4, is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Glycopyrrolate Impurity 12 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and regulatory compliance.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Pharmacopoeial Testing: Supports testing to meet the monograph requirements of major pharmacopoeias such as USP, EP, or BP where specified.

Basic Information

Item	Details
Product Name	Glycopyrrolate Impurity 12
CAS No.	857353-41-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	3-[(Cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium Impurity 12; Glycopyrronium Impurity 12; Glycopyrrolate Related Compound 12; (3RS)-3-[(2RS)-2-Cyclopentyl-2-hydroxy-2-phenylacetoxy]-1,1-dimethylpyrrolidinium Impurity; 857353-41-4; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Glycopyrrolate Impurity 12 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.