Description

Glycopyrrolate Bromide Impurit P is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of glycopyrrolate bromide, an anticholinergic medication, by enabling the accurate identification and quantification of this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production. The product is supplied with comprehensive analytical data to support regulatory compliance and method validation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of Impurity P in Glycopyrrolate Bromide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-High-Performance Liquid Chromatography (UHPLC), and other chromatographic methods.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Used as a marker to track the formation of degradation products in glycopyrrolate bromide formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product-related impurities.
• Contract Research and Testing Laboratories: A vital reagent for third-party labs offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Glycopyrrolate Bromide Impurit P
CAS No.	173277-80-0
Molecular Formula	C19H28BrNO3
Molecular Weight	398.34 g/mol
Synonyms	3-[(Cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium Bromide Impurity P; Glycopyrronium Bromide Impurity P; (3RS)-3-[(2RS)-2-Cyclopentyl-2-hydroxy-2-phenylacetoxy]-1,1-dimethylpyrrolidinium Bromide Related Compound P; 1-Methyl-3-[(S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy]pyrrolidinium Bromide Impurity; Glycopyrrolate Related Substance P; Glycopyrrolate Bromide EP Impurity P; Glycopyrrolate Bromide USP Impurity P
EINECS	Contact for details

Quality Control

Every batch of Glycopyrrolate Bromide Impurit P is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support regulatory filings with full traceability and stability data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. Ensure the container is sealed immediately after use to minimize exposure to atmospheric humidity.

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%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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