Description

Anisodine Impurity 4 (CAS NO 59216-85-2) is a defined chemical reference standard critical for ensuring the purity and safety of pharmaceutical products. This compound is essential for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily required by research institutions, quality assurance laboratories, and manufacturers involved in the synthesis and purification of Anisodine and related pharmaceutical actives.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Anisodine active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of drug products.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Anisodine Impurity 4
CAS No.	59216-85-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anisodine Related Compound 4; Anisodine EP Impurity 4; Anisodine USP Impurity 4; 6β-Hydroxyhyoscyamine; 6-Hydroxyhyoscyamine; 6β-Hydroxyatropine; (1R,3r,5S,8R)-6-Hydroxy-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (2S)-3-hydroxy-2-phenylpropanoate
EINECS	Contact for details

Quality Control

Every batch of Anisodine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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