TDS

TDS is available on https://www.eposrl.com/en/our-extracts/products/; you can access it by clicking on ‘Technical Datasheet’ button, after a quick and simple registration.

TDS is organized in two sections:

  1. general information on the plant and relevant extract, which are retrieved from suppliers (i.e. agronomical data), Italian Ministry of Health (i.e. physiologic and healthcare applications) and bibliographical data (i.e. active substances of the plant).
  2. analytical information and technical specifications: analytical methods are usually retrieved from Ph. Eur. current edition, except where otherwise specified. The following symbol (*) identifies analysis performed on a specific self-control plan. TDS only reports analytical data within a range of acceptability, while batch-specific results are reported on the CoA.

Additional information about TDS

  1. GMO, BSE-TSE and GLUTEN free information are reported on TDS.
  2. Residual solvents are not reported for extracts produced using water as the only solvent. For all other extracts, compliance with current Directive on matter of residual solvents are reported on TDS.
  3. For standardized extract only the analytical marker percentage is indicated in TDS; the DER (Drug-Extract ratio) is not indicated since it depends on the concentration of the analytical markers that must be achieved in the final extract. If DER is mandatory (according to local law authorities i.e. for product registration), a statement will be issued, upon indication of the local Regulation in force.
  4. When DER is specified, it represents the final ratio (including excipients) and not native ratio, as reported in TDS.
  5. Physiologic and healthcare applications do not refer to EFSA or FDA approved claim; data is usually retrieved from Ministerial Decree 9 January 2019 annex I.
  6. TDS has no expiry date. This document is:
    1. updated, when new information that does not alter any manufacturing characteristics (i.e. country of plant origin, collection period) becomes available; updated versions are always available at https://www.eposrl.com/en/our-extracts/products/.
    2. revised, when new information that possibly affects the extract characteristics (i.e. new excipient) becomes available; revised versions are always communicated to Customers by e-mail according to current Change Control SOP.
  7. Organoleptic data (i.e. color) is reported in section 2 of TDS and has wide range of acceptability due to natural vegetal raw material variability, without affecting the extract quality.
  8. The nutritional values reported in the first section of TDS are merely indicative; the analysis is mandatory for finished products only.

For liquid extract, over time, a slight sediment may form on standing, as reported by Ph.Eur. 10th edition. The phenomenon is due to hydro-dispersible substances of the phytocomplex (e.g. fibers and tannins) and does not affect the final quality of the extract, indeed, it demonstrates its naturalness.

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