Description

Gastrodin Impurity 4 is a specified impurity and reference standard used in the analytical profiling of Gastrodin, a key bioactive compound derived from the traditional Chinese herb *Gastrodia elata*. This compound is critical for ensuring the purity, safety, and efficacy of Gastrodin and its related pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and quality control departments for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Gastrodin Impurity 4 in Gastrodin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Serves as a critical tool for in-process testing and release testing of Gastrodin to meet pharmacopeial standards (e.g., USP, EP, ChP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Gastrodin formulations.
• Research & Development (R&D): Used in synthetic chemistry and phytochemical research to study the degradation pathways and metabolism of Gastrodin.

Basic Information

Product Name	Gastrodin Impurity 4
CAS No.	817206-76-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gastrodin Related Compound 4; Gastrodin EP Impurity D; Gastrodin USP Impurity 4; 4-Hydroxybenzyl alcohol 4-O-β-D-glucopyranoside impurity; p-Hydroxybenzyl alcohol β-D-glucoside impurity; Tianma impurity; Gastrodioside impurity
EINECS	Contact for details

Quality Control

Our Gastrodin Impurity 4 is manufactured under strict quality systems to ensure batch-to-batch consistency and high purity. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques such as HPLC, NMR, and MS for identity confirmation and purity assessment. We ensure compliance with relevant standards for pharmaceutical reference materials. Certificates of Analysis (COA) are available upon request.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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