Description

Imp. D (Ep) As Hydrochloride: cis-4-[(2-Amino-3,5-Dibromobenzyl)Amino]Cyclohexanol Hydrochloride is a high-purity chemical reference standard and a key synthetic intermediate in advanced pharmaceutical research. Its primary value lies in its critical role in the development and quality control of active pharmaceutical ingredients (APIs), particularly for complex, small-molecule therapeutics. This compound is essential for researchers and manufacturers in the pharmaceutical and biotechnology sectors who require precise analytical standards for method development, validation, and impurity profiling to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard (Impurity D) for analytical method development and validation in API quality control.
• Drug Discovery & Development: Used as a critical building block or intermediate in the synthesis of novel therapeutic candidates.
• Analytical Research: Employed in HPLC, LC-MS, and other chromatographic studies for impurity identification and quantification.
• Process Chemistry: Acts as a key intermediate in scale-up and optimization of synthetic routes for target molecules.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity data for drug master files.
• Academic Research: Utilized in university and institutional labs for medicinal chemistry and pharmacological studies.

Basic Information

Item	Details
Product Name	Imp. D (Ep) As Hydrochloride: cis-4-[(2-Amino-3,5-Dibromobenzyl)Amino]Cyclohexanol Hydrochloride
CAS No.	1384955-66-1
Molecular Formula	C13H19Br2ClN2O
Molecular Weight	422.56 g/mol
Synonyms	cis-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride; 4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexanol hydrochloride (cis-); Impurity D Ep As Hydrochloride; (1r,4r)-4-[[(2-Amino-3,5-dibromophenyl)methyl]amino]cyclohexan-1-ol hydrochloride; UNII-9J8B16411I; 9J8B16411I; cis-4-{[(2-Amino-3,5-dibromophenyl)methyl]amino}cyclohexanol hydrochloride
EINECS	Contact for details

Quality Control

Our Imp. D (Ep) As Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting all critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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