Description

Propantheline Bromide Related Compound A (9-Hydroxypropantheline Bromide) is a key reference standard and impurity used in the pharmaceutical development and quality control of anticholinergic medications. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) by enabling precise identification and quantification of related substances. It is primarily utilized by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance for drugs containing propantheline bromide.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of 9-Hydroxypropantheline Bromide in propantheline bromide drug substances and finished products.
• Impurity Profiling & Control: Essential for method development and validation in HPLC and LC-MS analyses to monitor and control specified and unspecified impurities as per ICH guidelines.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of degradation products and establish shelf-life.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity standards for drug master files (DMFs) and new drug applications (NDAs).
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure drug substance and product specifications are met.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of propantheline bromide.

Basic Information

Product Name	Propantheline Bromide Related Compound A (9-Hydroxypropantheline Bromide)
CAS No.	93446-04-9
Molecular Formula	C23H30BrNO4
Molecular Weight	464.40 g/mol
Synonyms	9-Hydroxypropantheline Bromide; Propantheline Bromide Impurity A; Propantheline Bromide EP Impurity A; Propantheline Bromide Related Substance A; 9-Hydroxypropantheline; (2-Hydroxyethyl)diisopropylmethylammonium bromide xanthene-9-carboxylate derivative; 9-Carboxypropantheline Bromide Hydroxy Derivative; N-Methyl-N-(1-methylethyl)-N-[2-[[(9H-xanthen-9-yl)carbonyl]oxy]ethyl]-2-propanaminium bromide, 9-hydroxy-
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and controlled under strict quality management systems. Each batch is characterized using advanced analytical techniques including HPLC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for assay, related substances, and residual solvents, ensuring compliance with ICH Q3A/B and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.