EKSTRACTS
SPECIFICATION SHEET
symbol: DEP/40/02
| Product | PROPOLIS DRY EXTRACT 40% | |
| Name of raw material | Propolis | |
| Solvent | Ethanol 96% (V/V) \ph.Eur.1317(4100102) | |
| Drug – extract ratio (DER) | 2.5 : 1 | |
| Ingredients | Native extract 40% | |
| Guar gum 45% | ||
| Silicon dioxide 15% | ||
| Purpose of use | intermediate for food products and foodstuffs | |
| Quality data | Acceptance criteria | Method |
| Characteristics | consistency: free-flowing powder; colour: yellow-orange to brown, odour; aromatic, characteristic of propolis | organoleptic |
| SLoss on drying | not more than 8.0%(m/m) | Ph.Eur.2.8.17 |
| Total ash | max. 10%(m/m) | Ph.Eur.2.4.16 |
| Content of flavonoids as Catechin equivalent | not less than 10 % (m/m) | spectrophotometry / AlCl3 complexation |
| Content of phenolic compounds as Gallic acid equivalent | not less than 15 % (m/m) | Spectrophotometry / Folin-Ciocalteu reagction |
| Residue of ethanol | not more than 1%(m/m) | Ph.Eur.2.4.24 |
| Microbiological purity | ||
| Total aerobic microbial count (TAMC) | max. 50 000 jtk/g (The limit interpreted as “factor x 5 or 2” (in accordance with section 5.1.4 or 5.1.8 of the Pharmacopoeia)) | FP 2.6.12 |
| Total combined yeasts/moulds count (TYMC) | max. 500 jtk/g (The limit interpreted as “factor x 5 or 2” (in accordance with section 5.1.4 or 5.1.8 of the Pharmacopoeia)) | FP 2.6.12 |
| Escherichia coli | absent in 1g | FP 2.6.31 |
| Salmonella | absent in 25g | FP 2.6.31 |
| Staphylococcus aureus | absent in 1g | FP 2.6.13 |
| Package | double polyethylene bag and cardboard. Other packages are allowed at customer’s request | |
| Labelling | name and code of product, batch number, production date, shelf life, net mass, gross mass, tare | |
| Storage | stored in a well-closed container, protected from moisture and light, at the temperature not exceeding 25oC | |
| Shelf life | 18 months |