Table 1.
Ingredients assay and specifications and purity profile.
| Test Product | PI | PII | PIII |
|---|---|---|---|
| Producer | Gnosis | Kappa Bioscience | Sungen |
| Appearance | Light yellowish powder | White to light yellow fine powder | Yellowish powder |
| Loss on drying | ≤5% | <5% | <5% |
| Total heavy metals | ≤10 ppm | ≤10 ppm | ≤10 ppm |
| Total aerobic microbial count | ≤103 CFU/g | ≤103 CFU/g | ≤103 CFU/g |
| Total combined yeasts & molds | ≤102 CFU/g | ≤102 CFU/g | ≤102 CFU/g |
| Declared quantity MK7 | 2000 ppm | 2000 ppm | 2000 ppm |
| Actual quantity MK7 | 2066 ppm | 1911 ppm | 2264 ppm |
| % actual/declared | 103% | 96% | 113% |
| All-trans-MK7 (area%) (US Pharmacopeia (USP) 97.4) |
99.3 | 92.7 | 93.7 |
|
cis-MK7 (area%) (USP 1.2) |
0.2 | 1.4 | 0.3 |
| MK6 (area%) (USP 0.03) |
0.6 | 0.2 | 2.5 |
|
# undefined chromatographic peaks (USP 6) |
0 | 23 | 19 |