Description

Balipramine Hydrochloride (Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Balipramine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard for quality control and assurance testing.
• Analytical Method Development and Validation in HPLC, LC-MS, and other chromatographic systems.
• Pharmacological and Metabolic Research to study drug degradation pathways.
• Regulatory Compliance and Documentation for FDA, EMA, and other health authority submissions.
• Stability Studies to monitor the formation of degradation products in drug formulations.
• Calibration of Analytical Equipment to ensure accurate quantification of impurities.

Basic Information

Product Name	Balipramine Hydrochloride (Impurity)
CAS No.	58262-51-4
Molecular Formula	C₁₉H₂₃ClN₂O • HCl
Molecular Weight	359.31 g/mol
Synonyms	Balipramine HCl Impurity; 1-[3-(Dimethylamino)propyl]-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one Hydrochloride; 5-Phenyl-1-[3-(dimethylamino)propyl]-1,3-dihydro-2H-1,4-benzodiazepin-2-one Hydrochloride; Balipramine Related Compound; Balipramine Degradation Product; Balipramine Process Impurity; 58262-51-4
EINECS	Contact for details

Quality Control

Our Balipramine Hydrochloride (Impurity) is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets stringent standards for use as a reference material. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided with every shipment.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.