Description

Clidinium Bromide Related Compound A (250 Mg) (3-Hydroxy-1-Methylquinuclindinium Bromide) is a high-purity analytical reference standard and a key pharmaceutical intermediate. This compound is critical for quality control and research & development within the pharmaceutical industry, ensuring the purity and efficacy of active pharmaceutical ingredients (APIs). It is primarily utilized by manufacturers and analytical laboratories for method development, validation, and impurity profiling of clidinium bromide-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of related substances in clidinium bromide drug substances and finished products.
• Impurity Profiling: Used in analytical method development (HPLC, LC-MS) to characterize and control process-related impurities and degradation products.
• Research & Development: Acts as a crucial intermediate or metabolite analog in pharmacological and pharmacokinetic studies.
• Quality Assurance/Quality Control (QA/QC): Essential for in-house testing protocols to ensure batch-to-batch consistency and compliance with pharmacopeial monographs (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs) and regulatory filings to demonstrate comprehensive impurity control.

Basic Information

Product Name	Clidinium Bromide Related Compound A (250 Mg) (3-Hydroxy-1-Methylquinuclindinium Bromide)
CAS No.	76201-95-1
Molecular Formula	C10H20BrNO
Molecular Weight	250.18 g/mol
Synonyms	3-Hydroxy-1-methylquinuclidinium bromide; 1-Methyl-3-hydroxyquinuclidinium bromide; Quinuclidinium, 3-hydroxy-1-methyl-, bromide; Clidinium Bromide Impurity A; Clidinium Bromide Related Substance A; Clidinium EP Impurity A; Clidinium Bromide Metabolite
EINECS	Contact for details

Quality Control

Every batch of Clidinium Bromide Related Compound A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity quantification. Certificates of Analysis (COA) detailing batch-specific results from advanced analytical techniques (HPLC, NMR) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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