Description

Berberine Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of berberine-based pharmaceutical products, ensuring their safety and efficacy. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance teams involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in berberine active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure product purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity over time under various storage conditions.
• Research & Development: Used in metabolic studies, degradation pathway elucidation, and synthetic chemistry research related to berberine and its analogs.

Basic Information

Product Name	Berberine Impurity 2
CAS No.	2043361-62-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Berberine Related Compound 2; Berberine Impurity B; Berberine EP Impurity B; Berberine USP Impurity; 13-Methylberberine (tentative, contact for confirmation); Berberine Analog; Isoberberine derivative; Protoberberine alkaloid impurity
EINECS	Contact for details

Quality Control

Our Berberine Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is 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). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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