Specification Neuravena (EFLA955) - Wild Green Oat powder extract

Avenae sat. Hba extr.s.sicc

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Plant species Avena sativa L. (selected variety Neuravena)

Plant material herba (green)
Extraction medium 30 %(m/m) Ethanolum
Drug:native extract ratio 4-6=1 (5=1)
Drug:extract ratio 3-4=1 (3.5=1)
Identity of raw material Qualitative TLC (AV-51-1184)
Appearance light brown powder, sifted through 0.7 mm (25 mesh)

Test Monograph/Method Unit Specifications

Appearance AV-51-0097 see above

Loss on drying Ph.Eur. 2.8.17 % m/m 5.0
Water content KF AV-51-0115 % m/m 5.0
Bulk density Ph.Eur. 2.9.34 g/ml 0.3 - 0.6
Flavonoids (calc.as Isovitexin) AV-51-0233 % m/m 0.3
Aerobic bacteria (TAMC) Ph.Eur. 2.6.12 cfu/g 10000
Yeasts and moulds (TYMC) Ph.Eur. 2.6.12 cfu/g 100
Bile-tolerant gram-negative bacteria Ph.Eur. 2.6.31 cfu/g 100
Escherichia coli Ph.Eur. 2.6.31 cfu/g n.d
Salmonella Ph.Eur. 2.6.31 cfu/25g n.d

Declaration
Carrier 28 %(m/m) Maltodextrinum Ph.Eur./USP
Preservation none
Additives 2 %(m/m) Silica colloidalis anhydr. Ph.Eur.
Residual solvent ethanol < 0.5 %(m/m) (GC/Ph; ICH/283/95, Class 3)
Comment In case LOD is exceeded, Karl Fischer water content applies.

The raw plant material complies to European Pharmacopoeia regarding heavy metals, mycotoxins and pesticide residues.
Radioactivity < 370 Bq/kg.

First release: 01. Feb 06 MN Last Change: 11. Nov 14 (.00 7) Print date: 12.02.2015
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