Quality & Compliance

Every certificate, every batch, fully traceable

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ISO 17034 Aligned

Reference material production aligned with ISO 17034:2016 requirements; ISO 9001 certified operations.

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Batch-Specific COA

Every batch certified with HPLC/GC purity, 1H/13C NMR identity, HRMS, water content (KF) and residue data.

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Chiral Purity

Chiral standards verified by chiral HPLC with ee% reported on the COA.

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Export Documentation

COA, SDS, certificate of origin, non-proliferation and end-use statements for smooth customs clearance.

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Traceability

Full chain of custody from raw material to final vial; stability and re-test date assigned per batch.

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Pharmacopoeial Alignment

Products named and mapped to EP, USP, BP and ICH Q3A/B impurity categories.

Our Analytical Testing Laboratories

Independent QC capability — instruments, methods and people you can audit.

Bruker Ascend 400 NMR with VEXORA label
核磁共振波谱（NMR）— Bruker Ascend 400用于结构确证，可完成一维/二维核磁全解析
Analyst loading samples
Qualified Analyst TeamMethods run under ICH Q2(R2) validated procedures
TGA thermogravimetric analyzer
TGA / DSC Thermal SuiteWater content, solvate and hydrate form confirmation
LC-MS/MS triple quadrupole
LC-MS/MS (Triple Quad)Trace-level quantitation and HRMS structure confirmation
High-resolution Q-TOF mass spectrometer
HRMS (Q-TOF / Orbitrap)Exact mass confirmation for identity and impurity elucidation
GC-MS system
GC-MS SystemResidual solvents and volatile genotoxic impurities (ICH Q3C / M7)