Reference Material Supply

Reference standards are characterized materials with well-defined purity, molecular structure and quantitative content, providing metrological benchmarks for end-to-end pharmaceutical QC. They are widely applied in drug identification, assay of active ingredients, impurity-limit quantitation and chromatographic method calibration — core materials indispensable to pharmaceutical R&D, manufacturing and regulatory submission.

STD operates within a dual-accreditation framework (CNAS 17034 reference-material producer + CNAS 17025 testing laboratory) and independently executes the full chain of reference-standard development, synthesis, isolation and certified-value assignment. The product portfolio spans two core categories: filing-grade reference standards traceable to ChP and WHO international reference materials for high-tier quantitation; and in-house certified working standards periodically cross-checked against filing-grade benchmarks for routine QC. Custom impurity reference standards are delivered after impurity isolation, targeted synthesis, full structural confirmation and homogeneity/stability investigation, supporting generic-drug consistency evaluation and new-drug impurity profiling.

Every batch ships with a compliant COA that fully records purity, content, water content, residual solvents, storage conditions, shelf life and uncertainty assessment, accompanied by complete NMR/LC/MS raw spectra. All data is governed by the dual-CNAS control system; the metrological traceability chain is complete and auditable, supporting domestic CDE registration, overseas drug submission and on-site GMP inspection.