Tacrolimus – Certified Reference Material (CAS 104987-11-3)

Tacrolimus (FK506, CAS 104987-11-3) is a macrolide immunosuppressant widely used in organ transplant protocols and as a reference compound in therapeutic drug monitoring (TDM) programs. ReChem Labs supplies Tacrolimus as a Certified Reference Material (CRM) at ≥99.5% verified purity by HPLC, manufactured and released under our ISO 9001:2015 quality management system. Each lot is independently tested using reverse-phase HPLC, supported by NMR characterization and LC-MS identity confirmation. The batch-specific Certificate of Analysis (COA) details purity, water content, residual solvents, and full measurement uncertainty in accordance with ISO 17511 traceability requirements — making this CRM directly suitable for regulatory submissions and proficiency testing programs. Primary applications include: LC-MS/MS method validation for whole-blood Tacrolimus TDM, calibrator and QC material preparation for clinical immunosuppressant panels, EQAS participation, and pharmacokinetic/pharmacodynamic modeling in transplant medicine research.

Product Specifications

CAS Number	104987-11-3
Molecular Formula	C₄₄H₆₉NO₁₂
Purity	≥99.5% (HPLC)
Standard Type	CRM, NIST-Traceable
Storage	−20°C, protect from light
Pack Sizes	10 mg | 25 mg | 50 mg
Documentation	Batch COA, SDS, NIST-Traceable Certificate

Key Features

• Purity ≥99.5% confirmed by HPLC, NMR, and LC-MS identity verification
• NIST-traceable COA with full measurement uncertainty budget (ISO 17511)
• ISO 9001:2015 manufactured and quality-released
• Suitable for LC-MS/MS TDM validation, calibrators, QC materials, and EQAS programs
• Supplied in amber glass vials under Nitrogen atmosphere
• Same-day dispatch from Houston, TX (orders placed before 2 PM CST)