Description

Xylazine Impurity E 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 and active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories, quality control units, and research scientists in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Xylazine-related impurities in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of analytical procedures for Xylazine API.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of specific degradants over time.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Xylazine.

Basic Information

Product Name	Xylazine Impurity E
CAS No.	219500-63-7
Molecular Formula	C₁₂H₁₆N₂S
Molecular Weight	220.33 g/mol
Synonyms	N-(2,6-Dimethylphenyl)-5,6-dihydro-4H-1,3-thiazin-2-amine; Xylazine Degradant E; Xylazine Related Compound E; 2-(2,6-Dimethylphenylamino)-5,6-dihydro-4H-1,3-thiazine; Xylazine Metabolite; Xylazine EP Impurity E; Xylazine USP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Xylazine Impurity E is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliability for your critical analytical and regulatory needs.

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. For long-term storage, consider storing under an 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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