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Epitetracycline Hydrochloride — Reference Materials for Residue Analysis

Epitetracycline hydrochloride Precision Reference Materials for Confident Compliance

Drive accuracy in tetracycline residue monitoring with HPC Standards high-purity epitetracycline hydrochloride. Our traceable reference materialsavailable as neat substances or ready-to-use solutionsare manufactured and quality-controlled to international requirements, supporting ISOIEC 17025 workflows. Achieve robust LCMSMS calibration, verify epimer separation, and stabilize epimer ratios across food, feed, and environmental matrices. Each lot ships with a comprehensive COA, SDS, and stability guidance for audit-ready documentation, enabling reliable method validation, routine QC, and proficiency testing. Choose HPC Standards for proven expertise in veterinary drug epimers and uncompromising analytical performance.

Product

Catalog No./ CAS No.

Quantity

Price

ISO 17034 Reference Material

4-Epitetracycline hydrochloride

4-Epitetracycline hydrochloride

689977
23313-80-6

1X10MG

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High-quality reference materials for epitetracycline hydrochloride designed for robust quantification and confirmation in food and environmental residue testing. Manufactured and quality-controlled to international standards for confident regulatory compliance.

Overview

Epitetracycline hydrochloride is the hydrochloride salt of 4-epitetracycline, an epimeric transformation product of tetracycline-class antibiotics. It commonly forms via pH- and temperature-dependent epimerization of tetracycline and may co-occur with parent compounds in food-producing animals, aquaculture, and environmental matrices.

As an epimer, epitetracycline typically exhibits reduced antimicrobial activity compared to tetracycline; however, it is analytically relevant due to regulatory frameworks that consider the sum of tetracyclines and their epimers for compliance monitoring.

Chemical Identity and Properties

- Class: Tetracycline antibiotic epimer (hydrochloride salt)

- Typical characteristics: amphoteric, light- and pH-sensitive; forms chelates with divalent/trivalent cations; moderate polarity suitable for reversed-phase LC separations

- Transformation: forms from tetracycline via epimerization; interconversion can be matrix- and storage-dependent

Uses in Analytical Context

- Calibration and system suitability standard for LC–MS/MS or LC–DAD methods targeting tetracycline antibiotics and their epimers

- Identification and quantitation of degradation/impurity profiles in pharmaceutical, veterinary, and feed matrices

- Spike-recovery experiments, method validation (LOD/LOQ, linearity, trueness, precision), and proficiency testing in food and environmental labs

Regulatory Context

- Many jurisdictions regulate the sum of tetracyclines (e.g., tetracycline, oxytetracycline, chlortetracycline) and their 4-epimers in edible tissues, milk, eggs, honey, and aquaculture products

- Reference frameworks include EU veterinary residue regulations and Codex guidance; national programs frequently mandate monitoring of epimers alongside parent drugs

- Laboratories require validated methods and traceable reference materials to demonstrate conformity with maximum residue limits (MRLs) and to support official control programs

Monitoring in Food and Environment

- Food: muscle, liver, kidney, milk/dairy, eggs, honey, fish/shrimp and other aquaculture products

- Environmental: surface water, sediments, wastewater/effluents, manure, sludge-amended soils

- Drivers: antimicrobial stewardship, surveillance of veterinary drug use, and risk management of resistance development

Human Toxicity

- Tetracycline-class effects may include gastrointestinal disturbance, photosensitivity, and hypersensitivity reactions; class-related concerns for teeth/bone development in children

- Epitetracycline exhibits lower antimicrobial potency than tetracycline but remains relevant for cumulative exposure assessments

- Occupational exposure in labs should be minimized via engineering controls and PPE

Environmental Impact

- Fate: adsorption to soils/sediments, potential persistence under certain conditions, photolysis and biotransformation possible

- Effects: alteration of microbial communities, selection pressure for antimicrobial resistance; toxicity reported for algae and aquatic microorganisms at sufficient concentrations

- Monitoring supports risk assessments in water bodies affected by agricultural and aquaculture discharges

Degradation and Transformation

- Epimerization (tetracycline ⇌ epitetracycline) is pH- and temperature-dependent; can occur during sample storage and preparation

- Additional pathways: dehydration, oxidation, complexation with metal ions; these can impact analytical recoveries and signal response

Stability and Handling

- Store reference materials in tightly closed, light-protective containers at low temperature as specified on the certificate of analysis (e.g., 2–8 °C or ≤−18 °C)

- Avoid alkaline conditions and prolonged exposure to elevated temperatures; use metal-free solvents or control for chelating effects

- Prepare fresh working solutions; document freeze–thaw cycles and solution stability as part of method SOPs

Safety Measures and Storage

- Use appropriate PPE (lab coat, gloves, eye protection) and handle in a fume hood or well-ventilated area

- Avoid inhalation, ingestion, and skin contact; follow local regulations for antibiotic waste disposal

- Refer to the product safety data sheet (SDS) for hazard statements and first-aid measures

Analytical Methods

- LC–MS/MS (ESI+): preferred for selectivity and sensitivity; multiple reaction monitoring of epimer-specific transitions

- LC–UV/DAD: applicable for higher-level screening; less selective than MS-based detection

- Sample preparation: protein precipitation for milk; SPE (HLB/cation-exchange) or modified QuEChERS for tissues, honey, and aquatic matrices; include chelator or buffer to stabilize epimer ratios

- Quality controls: matrix-matched calibration, isotopically labeled internal standards where available, recovery checks and bracketing standards

Reference Materials from HPC Standards

- Epitetracycline hydrochloride reference materials for quantitative residue analysis across food and environmental matrices

- Options: neat material or solution formats; accompanied by certificate of analysis with purity, identity, and uncertainty information

- Manufactured and tested according to international quality requirements to meet the highest industrial standards; suitable for method validation, routine QC, and proficiency testing support

Matrix Applications

- Food: bovine/porcine/poultry muscle, liver, kidney, milk, eggs, honey, fish/shrimp

- Environmental: surface/ground water, effluents, sediments, soils, biosolids

- Feed and premixes: impurity/degradation profiling during stability studies

Quality and Compliance Support

- Batch traceability, documented purity and identity testing, and stability guidance enable audit-ready compliance

- Technical documentation supports accreditation to ISO/IEC 17025 methods and aligns with regulatory residue monitoring plans

Method Development Tips

- Control pH during extraction and analysis to minimize epimer interconversion

- Evaluate matrix effects and ion suppression; use matrix-matched calibration and internal standards when possible

- Verify epimer separation and response factors; include system suitability criteria for retention time and ion ratios

Logistics and Availability

- Secure packaging in amber vials to protect from light; temperature-controlled shipping available

- Lot-specific COA, SDS, and technical notes provided; global delivery to accredited laboratories and industry

Why HPC Standards

- Expertise in reference materials for veterinary drugs, pesticides, metabolites, and stable isotope-labelled derivatives

- Dedicated support for food and environmental analysis with products designed to ensure regulatory compliance and analytical reliability