Description

Mecamylamine Related Compound A (10 Mg) (N,1,7,7-Tetramethyl Bicyclo [2.2.1] Heptan-2-Amine Hydrochloride) is a high-purity analytical reference standard, specifically designated as a related substance of the ganglionic blocker Mecamylamine. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products through precise analytical testing. It is primarily required by analytical laboratories, quality control departments, and research institutions in the pharmaceutical and life sciences sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Mecamylamine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC, GC) to ensure specificity, accuracy, and robustness in impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and a calibrant in routine quality control testing to monitor batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Mecamylamine formulations under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in pharmacological and metabolic studies to understand the pathways and by-products associated with Mecamylamine.

Basic Information

Product Name	Mecamylamine Related Compound A (10 Mg) (N,1,7,7-Tetramethyl Bicyclo [2.2.1] Heptan-2-Amine Hydrochloride)
CAS No.	22321-23-9
Molecular Formula	C11H22ClN
Molecular Weight	203.75 g/mol
Synonyms	N,1,7,7-Tetramethylbicyclo[2.2.1]heptan-2-amine hydrochloride; 2-Aminobornane hydrochloride; 2-Bornanamine hydrochloride; 1,7,7-Trimethylbicyclo[2.2.1]heptan-2-amine, N-methyl-, hydrochloride; Mecamylamine Impurity A; Mecamylamine Related Substance A; Bornan-2-amine, N,1,7,7-tetramethyl-, hydrochloride
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality-controlled conditions to ensure the highest level of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as HPLC, NMR, and mass spectrometry for identity confirmation and purity assessment. Our quality system is designed to support cGMP and ISO 17034 standards for reference material producers, ensuring reliability for your critical analytical work.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F). The product is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment to maintain stability and prevent degradation.

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)	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.