Description

Glycopyrrolate Impurity (1,1-Dimethyl-3-Hydroxy-Pyrrolidinium Bromide) is a critical reference standard used in the analytical profiling and quality control of the anticholinergic drug Glycopyrrolate. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor this specific impurity, ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily used by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of 1,1-Dimethyl-3-Hydroxy-Pyrrolidinium Bromide in Glycopyrrolate Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure impurity levels are within specified limits, supporting batch-to-batch consistency and regulatory filings.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation and establish shelf-life for Glycopyrrolate formulations.
• Regulatory Compliance & Documentation: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Glycopyrrolate.

Basic Information

Product Name	Glycopyrrolate Impurity (1,1-Dimethyl-3-Hydroxy-Pyrrolidinium Bromide)
CAS No.	51052-74-5
Molecular Formula	C7H16BrNO
Molecular Weight	210.11 g/mol
Synonyms	1,1-Dimethyl-3-hydroxypyrrolidinium Bromide; 3-Hydroxy-1,1-dimethylpyrrolidinium Bromide; Glycopyrronium Impurity; Glycopyrrolate Related Compound; N,N-Dimethyl-3-hydroxypyrrolidinium Bromide; Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, bromide (1:1); Glycopyrrolate Degradation Product
EINECS	Contact for details

Quality Control

Our Glycopyrrolate Impurity 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 multiple orthogonal techniques, including HPLC, NMR, and mass spectrometry. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting your compliance with cGMP, ICH, and USP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or COA. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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