Description

Glycopyrrolate Impurity 19 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Glycopyrrolate. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by R&D scientists and QC/QA professionals in the pharmaceutical industry for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Glycopyrrolate Impurity 19 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Glycopyrrolate.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Glycopyrrolate formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing in accordance with standards set by USP (United States Pharmacopeia) or EP (European Pharmacopoeia).

Basic Information

Product Name	Glycopyrrolate Impurity 19
CAS No.	51052-77-8
Molecular Formula	C19H28BrNO3
Molecular Weight	398.34 g/mol
Synonyms	3-[(Cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium Bromide; Glycopyrronium Impurity 19; Glycopyrrolate Related Compound 19; 1-Methyl-3-[(S)-2-cyclopentyl-2-hydroxy-2-phenylacetoxy]-1-azoniabicyclo[2.2.2]octane Bromide; Glycopyrrolate EP Impurity B; Glycopyrrolate USP Impurity; Robinul Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Glycopyrrolate Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) methods to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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