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Division Specifications of the enzyme preparation of prolyl oligopeptidase

United Kingdom

Original text. Later amendments are not shown.

PPI — Protease Picomole International.

PPU — Prolyl Peptidase Units or Proline Protease Units.

Parameter Specifications Limits
Activity > 580 000 PPIf1/g (> 34,8 PPUf2/g)
Appearance Microgranulate
Colour Off-white to orange yellowish. The colour may change from batch to batch
Dry Matter > 94 %
Gluten < 20 ppm
Heavy metals
Total heavy metals (as lead)≤ 10 mg/kg
Lead≤ 1,0 mg/kg
Arsenic≤ 1,0 mg/kg
Cadmium≤ 0,5 mg/kg
Mercury≤ 0,1 mg/kg
Microbiological specifications
Total aerobic plate count≤ 103 CFU/g
Total yeasts and moulds≤ 102 CFU/g
Sulphite reducing anaerobes≤ 30 CFU/g
Enterobacteriaceae < 10 CFU/g
Salmonella Absent in 25 g
Escherichia coli Absent in 25 g
Staphylococcus aureus Absent in 10 g
Pseudomonas aeruginosa Absent in 10 g
Listeria monocytogenes Absent in 25 g
Antimicrobial activityAbsent
MycotoxinsBelow limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)

Annotations

Footnotes

f1

PPI — Protease Picomole International.

f2

PPU — Prolyl Peptidase Units or Proline Protease Units.