At PreciseMol Solutions, our Pharmaceutical Reference Standards are designed to support the full spectrum of pharmaceutical research, quality control, and regulatory compliance. We provide high-quality, fully characterized standards that empower scientists to achieve accuracy, reproducibility, and confidence in every analytical study. Here’s what sets our reference standards apart:
🔬 API Standards – High-purity active pharmaceutical ingredient standards for method development, validation, and QC, ensuring consistency across all analytical workflows.
⚗️ Excipient Standards – Comprehensive excipient reference materials to evaluate formulation performance, compatibility, and stability, enabling reliable pharmaceutical development.
🧪 Impurity Standards – Covering secondary, degradation, leachable, and nitrosamine impurities, our standards support identification, quantification, and regulatory compliance.
📊 Established Pharmacopoeial Standards – NDMA, NDEA, NDIPA, NDBA, and other widely recognized standards provide a trusted foundation for accurate testing.
🧩 Custom Impurity Standards – Tailored synthesis for process-related, degradation, or novel impurities not commercially available, meeting your unique research needs.
🚀 Stable Isotope-Labeled Standards – Deuterated APIs, peptides, amino acids, and metabolite standards for advanced analytical studies, including mass spectrometry.
⚙️ Metabolite Standards – Fully characterized metabolite reference materials to support pharmacokinetics, bioanalytical research, and safety studies.
🌍 Global Regulatory Alignment – All standards are produced and documented in compliance with ICH, USFDA, EMA, and other global guidelines, ensuring acceptance worldwide.
📈 ISO-Compliant Processes – Audit-ready production and documentation provide confidence in quality, traceability, and reproducibility for regulatory submissions.
🤝 End-to-End Scientific Support – From selection and sourcing to validation and guidance, our team works closely with clients to ensure the standards meet every analytical and regulatory requirement.