Quality control mixture for glycine tablets, a method for...

Chemistry: analytical and immunological testing – Peptide – protein or amino acid – Amino acid or sequencing procedure

Reexamination Certificate

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C436S008000, C436S017000, C436S164000, C436S166000, C436S174000

Reexamination Certificate

active

08043859

ABSTRACT:
A method is described for preparing a mixture for quality control of 0.1 g glycine tablets for sublingual application. The mixture for quality control includes a 100:0.5 ratio of ethanol to porphyrized tablets, each tablet containing 0.1 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with a polymeric film of water-soluble methylcellulose, each tablet further containing 0.001 g of magnesium stearate. The process for preparing the mixture includes dissolution of the tablet in ethanol for 20 minutes and is carried out at a temperature of 40° C. in an apparatus using a paddle rotation speed of 200 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes at room temperature, and then a light transmission coefficient is measured at 700±2 nm for a 10 mm thick layer of the mixture. A transmission value within the limits of 90% to 100% compared with 50% ethanol corresponds to the proper quality.

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International Search Report, mailed Sep. 11, 2008, from PCT/RU2008/000130, filed Mar. 6, 2008.
Gosudarstvennaya Farmakopeya SSSR. Desyatoe izdanie. Meditsina, Moscow, 1968, pp. 667-669.

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