BERB-1: Certified reference material of berberine chloride

The following tables show those constituents for which certified and information values have been established for this berberine purity certified reference material (CRM).

The certified value shows the purity of berberine chloride. Certified values are based on results from data generated at NRC using quantitative proton nuclear magnetic resonance spectroscopy (1H‑qNMR) and chemical specifications. The expanded uncertainty (UCRM) in the certified value is equal to U = kuc where uc is the combined standard uncertainty calculated according to the JCGM Guide and k is the coverage factor. A coverage factor of two (2) was applied for all substances. It is intended that UCRM accounts for every aspect that reasonably contributes to the uncertainty of the measurement.

Table 1: Certified quantity value for BERB‑1

Substance Molecular formula Mass fraction,
(g/g)
berberine (a) C20H18NO4+ 0.7892 ± 0.0053
berberine chloride (a) C20H18NO4Cl 0.9334 ± 0.0062

Table 2: Information values for impurities in BERB‑1

Substance Molecular formula Mass fraction,
(g/g)
palmatine chloride (b,c) C20H18NO4Cl 0.000 14
jatrorrhizine chloride (a,c) C20H20NO4Cl 0.002 23
coptisine chloride (b) C19H14NO4Cl 0.000 22

All alkaloids are identified here using their common names. The corresponding Chemical Abstract Services (CAS) Registry Numbers are as follows: berberine chloride (CAS 633-65-8), palmatine chloride (CAS 10605-02-4), jatrorrhizine chloride (CAS 6681-15-8), and coptisine chloride (CAS 6020-18-4).

Coding

The coding refers to the instrumental method of analyte determination.

  • a – Proton nuclear magnetic resonance spectroscopy (1H‑NMR)
  • b – Liquid chromatography mass spectrometry (LC‑MS)
  • c – Liquid chromatography UV‑Vis spectroscopy (LC‑UV)

Intended use

This reference material is primarily intended for use in the calibration of procedures and the development of methods for the determination of berberine. A minimum sample mass of 25 mg is recommended.

Uncertainty

Included in the combined uncertainty estimate (uc) are uncertainties in the batch characterization (uchar), uncertainties related to possible between-bottle variation (uhom), and uncertainties related to short-term stability (ustabity). Expressed as standard uncertainties, these components are listed in Table 3.

Table 3: Uncertainty Components for BERB‑1

Substance uc,
g/g
uchar,
(g/g)
uhom,
(g/g)
ustability,
(g/g)
berberine 0.0026 0.0009 0.0010 0.0023
berberine chloride 0.0031 0.0010 0.0012 0.0027

Date of issue: April 2015
Date of expiry: April 2025
Revised: March 2016 (editorial update)

Date modified: