Division Specifications
United Kingdom
| Lit. [α]D = (+) 126,6° (c = 1, H20) | ||
| Analyses conducted on each batch | ||
| Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5). | ||
| Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy; | ||
| CFU: colony-forming units. | ||
| Parameter | Specification | Method |
|---|---|---|
| Appearance | White powder | Visual |
| Optical rotation | [α]D ≥ (+) 122° (c = 1, H20)f1 | Polarimetry |
| Chemical purity | ≥ 99,5 % | HPLC [Eur. Ph. 2.2.29] |
| ≥ 99 % | 1H-NMR | |
| Identification | Compliant with the structure | 1H-NMR |
| C: 47,14 ± 0,4 % | ||
| H: 6,59 ± 0,4 % | ||
| N: 18,32 ± 0,4 % | Elemental analysis | |
| Total residual solvents (methanol, ethyl acetate, isopropanol, ethanol) | [Eur. Ph. 01/2008:50400] < 1 000 ppm | Gas chromatography [Eur. Ph. 01/2008:20424] |
| Loss on drying | Internal standard < 0,5 % | [Eur. Ph. 01/2008:20232] |
| Impurities | < 0,8 % | HPLC/GPC or 1H-NMR |
| Heavy metals f2 f3 | ||
| Lead | < 3 ppm | ICP/AES (Pb, Cd) Atomic fluorescence (Hg) |
| Cadmium | < 1 ppm | |
| Mercury | < 0,1 ppm | |
| Microbiological specifications | ||
| Total viable aerobic count (TVAC) | ≤ 1 × 103 CFU/g | [Eur. Ph. 01/2011:50104] |
| Total yeast and mould count (TYMC) | ≤ 1 × 102 CFU/g | |
| Escherichia coli | Absent in 1 g | |
Annotations
Footnotes
- f1
-
Lit. [α]D = (+) 126,6° (c = 1, H20)
- f2
-
Analyses conducted on each batch
- f3
-
Maximum levels in accordance with Commission Regulation (EC) No 1881/2006 (OJ L 364, 20.12.2006, p. 5).