Table 3.
Specifications of the NF
| Parameter | Specification |
|---|---|
| 25(OH)D3.H2O | 97.0–100% |
| Total related substances: | ≤ 1.5% |
| ∆22‐25(OH)D3 | ≤ 0.5% |
| Lumisterol(a) | ≤ 0.5% |
| pre‐25(OH)D3 (b) | ≤ 0.5% |
| Tachysterol(c) | ≤ 0.5% |
| trans‐Vitamin D3 (d) | ≤ 0.5% |
| Other impurities | ≤ 0.10% |
| Water content | 3.8–5.0% |
| Acetone (mg/kg) | ≤ 1,000 |
| Isopropanol (mg/kg) | ≤ 500 |
| Heavy metals | |
| Arsenic (mg/kg) | ≤ 1.0 |
| Lead (mg/kg) | ≤ 1.0 |
| Cadmium (mg/kg) | ≤ 0.5 |
| Mercury (mg/kg) | ≤ 0.1 |
a
9β,10α‐Cholesta‐5,7‐diene‐3β,25‐diol (25(OH)).
b
Cholesta‐5,7‐diene‐3β,25‐diol.
c
(6E)‐9,10‐Secocholesta‐5(10),6,8‐triene‐3β,25‐diol (iso‐25(OH)).
d
(5E,7E)‐9,10‐Secocholesta‐5,7,10(19)‐triene‐3β,25‐diol.