Description | Limits | 2-8oC | 40oC | |||||
---|---|---|---|---|---|---|---|---|
0 | 3 | 6 | 12 | 1 | 3 | 6 | ||
Particle size (light microscopy) | ≥ 60% of under 50 µm | S | - | S | S | NP | NP | NP |
Shape (light microscopy) | elongated tubular structures | S | - | - | S | NP | NP | NP |
pH | 7±0.5 | 7,4 | 7,1 | 7,1 | 7,1 | 7,2 | 7,2 | 7,3 |
Appearance | Milky suspension | S | S | S | S | S | S | S |
Free Ca2+ (atomic absorption) | <5 mM | <0,1 | <0,1 | NP | <0,1 | - | <0,1 | <0,3 |
Protein concentration (Lowry) | 1,2±0,2 mg/mL | 1,19 | 1,26 | NP | 1,27 | 1,19 | 1,2 | 1,26 |
Preservative (atomic absorption) | 0.07-0.13 mg/mL | 0.1 | NP | NP | 0,09 | NP | NP | NP |
Identity (SDS/PAGE) | two majority bands between 36 and 46 kDa and two minor between 70 and 85 kDa | P | P | NP | P | P | P | P |
Microbial limit | Less than <102 aerobic bacteria or fungi by Pseudomonas aeruginosa m. Absence of Staphylococcus aureus, Escherichia coli and Salmonella | S | S | NP | NP | NP | NP | NP |
Preservative | Microbial growth reduction <2 log at 14 days and no microbial growth increased from 14 to 28 days | S | S | NP | S | S | S | S |
Potency ELISA(IgA) | IgA in saliva anti OMV > 250 UA | 261.33 | 503 | NS | 882.17 | NS | NS | NS |
Potency ELISA(IgG) | IgG in serum anti OMV | S | S | S | S | S | S | S |