[Methods for the protection against counterfeit medications. Part 2. The assessment of interlot dispersion of the metoprolol succinate tablets fabricated by different manufacturers].

[Methods for the protection against counterfeit medications. Part 2. The assessment of interlot dispersion of the metoprolol succinate tablets fabricated by different manufacturers].

Sudebno-meditsinskaia ekspertiza (2013-01-01)

V A Iakushev, M A Morozova, T E Elizarova, S B Fitilev, T V Pletneva

ABSTRACT

This paper reports the results of analysis of the metoprolol succinate tablets fabricated by two different manufacturers, Akrikhin (Russia) and AstraZeneka (Sweden) by near-IR spectroscopy in the combination with the chemometric processing of the data obtained (discriminative analysis). It is concluded that this method is applicable for the assessment of interlot dispersion of the metoprolol succinate tablets.

MATERIALS

Product Number

Brand

Product Description

M5391

Sigma-Aldrich

(±)-Metoprolol (+)-tartrate salt, ≥98% (titration), powder

M1830000

Metoprolol tartrate, European Pharmacopoeia (EP) Reference Standard

PHR1076

Supelco

Metoprolol Tartrate, Pharmaceutical Secondary Standard; Certified Reference Material

M-123

Supelco

Metoprolol tartrate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant^®