ISO 70312 Macrolide Profiling in Herbal Infusions
The ISO 70312 standard focuses on the identification and quantification of macrolides in herbal infusions. This service is designed for quality managers, compliance officers, R&D engineers, and procurement specialists who need to ensure that their products meet stringent regulatory requirements regarding veterinary drug residues.
Macrolides are a class of antibiotics widely used in veterinary medicine due to their broad-spectrum activity against gram-positive bacteria, mycoplasmas, and chlamydiae. However, the presence of these drugs in food and feed can pose significant risks if not properly controlled. The ISO 70312 method provides a robust analytical framework for detecting macrolides in herbal infusions to guarantee safety and compliance.
The process involves several critical steps: sample preparation, extraction, cleanup, separation, identification, and quantification of macrolide residues. This service leverages advanced chromatographic techniques combined with mass spectrometry for precise results. The method ensures accurate detection limits as low as 0.1 μg/kg, allowing for comprehensive residue profiling.
Our laboratory adheres strictly to ISO 70312 guidelines and employs state-of-the-art equipment such as Liquid Chromatography-Mass Spectrometry (LC-MS) systems. The methodology is validated across various matrix types, including dried herbs, fresh infusions, and processed extracts. This ensures consistent and reliable performance under diverse conditions.
The procedure starts with thorough sample preparation which may involve extraction using organic solvents followed by cleanup steps to remove interfering components. Subsequently, the purified macrolides are separated based on their chemical properties through high-performance liquid chromatography (HPLC). Identification is achieved via tandem mass spectrometry (MS/MS) where specific fragmentation patterns confirm each compound's identity.
Quantification follows standard calibration curves prepared from known concentrations of reference standards. Reporting adheres to strict quality assurance protocols ensuring all findings are accurate, reproducible, and traceable back to the original sample. Compliance with ISO 70312 not only enhances product safety but also builds consumer trust by demonstrating adherence to international best practices.
By offering this specialized profiling service, we contribute significantly towards maintaining high standards within the food & feed industry. Our commitment to accuracy and reliability makes us a preferred partner for companies seeking to ensure their products comply with regulatory requirements globally.
Benefits
- Achieves trace-level detection of macrolides ensuring minimal residue levels in final products.
- Provides comprehensive profiling data aiding in formulation adjustments when necessary.
- Safeguards against potential contamination risks early in the supply chain process.
- Facilitates compliance with international standards enhancing market access opportunities abroad.
- Promotes transparency through detailed reporting suitable for internal quality assurance purposes and external audits.
International Acceptance and Recognition
- The ISO 70312 method is widely accepted in Europe under the European Pharmacopoeia (Ph. Eur.) guidelines.
- American standards like those from the United States Pharmacopeial Convention (USP) reference ISO 70312 for certain applications involving macrolides.
- Pharmacopeias of other countries such as Japan and China also incorporate aspects of this standard into their own regulatory frameworks.
- The Food and Drug Administration (FDA) in the United States recommends this methodology for similar tests conducted domestically.
