Chemical and analytical studies necessary for the development and standardization of pharmaceuticals of natural and synthetic origin

  • development/adoption of techniques for analysis and standardization of single and multicomponent pharmaceuticals of natural and synthetic origin in various medical forms (oil extracts, dry extracts, suppositories, tablets, capsules, syrups, tinctures, etc.);
  • development/adoption of analytical techniques in dissolution test and study of release of active components in vitro;
  • validation of analytical techniques;
  • study of stability of objects in conditions of natural storage and “accelerated” aging;
  • preparation of draft regulations (Manufacturer monograph, Technical specification) about pharmaceuticals, biologically active additives (BAA), functional nutrition, etc. for pharmaceutical, food and cosmetic industry.

Preparation of draft regulations is carried out according to the following requirements:

  1. State Pharmacopoeia of the Russian Federation, ed. 12, Part 1, M., 2008, 704 pp;
  2. State Pharmacopoeia of the USSR, ed. 11 revised and ext., Part 1, M., 1987, 335 pp; Part 2, M., 1989, 398 pp;
  3. OST 91500.05.001-00 Quality standards of medicines. Basic provisions, M., 2000, 54 pp;

4. Leading foreign pharmacopeias.