✨ ISO/IEC 17025 Accredited Analytical Release
Certificate of Analysis (COA)
Every Karpschem reference standard is released with an auditable analytical dossier containing 1H/13C NMR, HRMS, and HPLC purity chromatograms.
Document Identifier: KC-COA-2026-NIT001
KARPSCHEM
ISO/IEC 17025:2017 & WHO-GMP COMPLIANT QUALITY SYSTEMSCERTIFICATE OF ANALYSIS
Batch No: KC-B26-0309 | Issue Date: Jan 2026
Product Name: N-Nitrosodiethylamine (NDEA)
IUPAC Name: N-Ethyl-N-nitrosoethanamine
Catalog Number: KC-NIT-001
CAS Number: 55-18-5
Molecular Formula: C₄H₁₀N₂O
Molecular Weight: 102.14 g/mol
Storage Conditions: -20°C, Inert Atmosphere, Protected from Light
Recommended Re-Test Date: January 2028
Analytical Verification Matrix
| Test Parameter | Monograph / Target Specification | Observed Analytical Value | Conclusion |
|---|---|---|---|
| Appearance | Pale yellow clear liquid/oil | Complies | Conforms |
| Identification (¹H-NMR) | Conforms to theoretical vector structure | Conforms (300 MHz, CDCl3) | Conforms |
| Identification (¹³C-NMR) | All expected aliphatic carbons accounted | Conforms (75 MHz, CDCl3) | Conforms |
| High-Resolution Mass (HRMS) | m/z [M+H]⁺ = 103.087 ± 0.005 | 103.0868 m/z (Δ = -1.2 ppm) | Conforms |
| Chromatographic Purity (HPLC) | ≥ 98.0% (area normalization at 230 nm) | 99.42% | Conforms |
| Water Content (Karl Fischer) | ≤ 0.50% w/w | 0.14% w/w | Conforms |
| Residual Solvents (GC-HS) | Meets ICH Q3C Class 2/3 limits | Methanol: 180 ppm, DCM: Not Detected | Conforms |
Tested By: Senior Analytical Chemist, PhD
Karpschem Quality Control Division
Approved By: Head of Quality Assurance & Compliance
✓ CERTIFIED & RELEASED