Description

Berberine Impurity 1 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 berberine and its related pharmaceutical products. It is primarily utilized by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification as a certified reference material for berberine-based drugs.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques in QC laboratories.
• Stability Studies to monitor and quantify degradation products in berberine formulations.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Chemical Research as a building block or intermediate in the synthesis of berberine analogs.
• Calibration Standard for ensuring accuracy and precision in quantitative analysis.

Basic Information

Product Name	Berberine Impurity 1
CAS No.	430433-40-2
Molecular Formula	C₂₀H₁₈NO₄⁺
Molecular Weight	336.36 g/mol
Synonyms	8-Oxoberberine; Berberine Related Compound A; 8-Oxoberberinium; 5,6-Dihydro-9,10-dimethoxybenzo[g]-1,3-benzodioxolo[5,6-a]quinolizin-8-ium-8-olate; Berberrubine impurity; Berberine degradation product; Berberine metabolite analog
EINECS	Contact for details

Quality Control

Every batch of Berberine Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (IR, NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 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.