Supply of reference materials, analytical standards, and impurities to support laboratory testing, method validation, and compliance with international pharmacopeial standards.
Our solutions are designed to help mitigate the most critical laboratory risks:
Our solutions are designed to help mitigate the most critical laboratory risks:
Official pharmacopeial standards, reference APIs, impurities, and related substances for reliable analytical testing, method validation, and quality control.
We ensure compliance with the required transportation and storage conditions for standard, hazardous, and refrigerated reference materials, preserving their integrity and quality.
USP · Ph. Eur./EDQM · BP. Reference standards and materi.als used in official pharmacopeial tests for identity, assay, purity, impurities, and analytical compliance.
Active Pharmaceutical Ingredients for Analytical Use. Reference substances used for identification, assay, analytical comparison, method development, and quality control of raw materials and finished products.
Degradation Products · Intermediates · Metabolites. Reference materials used to identify, quantify, and monitor impurities, degradation products, and related substances in stability studies and analytical method validation.
Sigma Supelco · LGC Standards.
Analytical alternatives for calibration, method verification, and routine laboratory analysis, supported by appropriate documentation and traceability according to the type of reference material.
We help you select the most appropriate reference material based on your analytical method, pharmacopeia, and laboratory requirements.
We understand that reference standards, reagents, and reference materials require comprehensive technical and documentary support to ensure reliable laboratory use. Depending on the manufacturer, pharmacopeia, or supplier, we can provide:
We understand that reference standards, reagents, and reference materials require comprehensive technical and documentary support to ensure reliable laboratory use. Depending on the manufacturer, pharmacopeia, or supplier, we can provide:
Find answers to the most common questions about pharmacopeial standards, reagents, certified reference materials, and secondary standards used in analytical testing, quality control, and analytical method validation.
Reference standards are used as reliable comparison materials in laboratory testing for identity, assay, purity, impurity analysis, system suitability, calibration, analytical method validation, and quality control.
No. Reference standards are intended exclusively for analytical use, laboratory testing, and quality control. They must not be used in humans, animals, pharmaceutical formulations, medical devices, or therapeutic applications.
A primary reference standard provides the highest level of traceability and serves as the reference material. A secondary reference standard is qualified against a primary reference standard, while a working standard is used for routine analysis after documented in-house qualification.
For more information, contact one of our technical specialists.
No. Reagents are used to prepare solutions, generate chemical reactions, or perform analytical methods. Reference standards are used as comparison materials to verify identity, purity, potency, concentration, or analytical method performance.
A secondary or working standard should be supported by the original material certificate, qualification records against a primary reference standard or Certified Reference Material (CRM), assigned potency or purity calculations, preparation date, storage conditions, internal expiration date, and documented approval by the responsible personnel.
