3'-Sialyllactose sodium
Compositional guideline for '3'-Sialyllactose sodium' permitted for use in listed medicines
Name of the ingredient
3'-Sialyllactose sodium (AAN #140164)
Definition of the ingredient
3'-Sialyllactose (3'-SL) sodium is a purified, white to off-white powder or agglomerate that is produced by a microbial process that involves the genetically modified strain, Escherichia coli K-12 DH1. It contains limited levels of D-lactose, 3'-sialyl-lactulose, and sialic acid.
Molecular formula: C23H38NO19Na
CAS Number: 1128596-80-5
Structure:
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | ISO 6658 | Powder, agglomerates, powder with agglomerates |
| Colour | ISO 6658 | White, white to off-white, off-white |
| Characteristics | ||
| pH in 5% solution (20°C) | Ph Eur 2.2.3 | 4.5 to 6.0 |
| Water | Karl-Fischer | ≤8.0% w/w |
| Identification | ||
| NMR | Urashima et al, 2009[1] | Recorded 1H NMR spectrum must be in full agreement with the structure of 3'-sialyllactose. |
| HPAEC | HPAEC[2] | Retention time of the main peak corresponds to the retention time of 3'-sialyllactose standard ±3% |
| Assay | ||
| 3'-Sialyllactose sodium (water-free) | HPAEC[2] | ≥88.0% w/w |
| Human-identical milk saccharides (water-free) | Calculated theoretically as the summation of percentages of 3'-sialyllactose sodium, D-lactose, and N-acetylneuraminic acid (sialic acid). | ≥90.0% w/w |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Related substances | ||
| D-Lactose | HPAEC[3] | ≤5.0% w/w |
| Sialic acid | HPAEC[2] | ≤1.5% w/w |
| 3'-Sialyl-lactulose | HPAEC[2] | ≤5.0% w/w |
| Incidental metals and non-metals | ||
| Lead | EN 13805:2002; EPA 6020A:2007 | ≤0.1 mg/kg |
| Other organic or inorganic impurities or toxins | ||
| Sodium | GOST 31869-2012 | 2.5 to 4.5% w/w |
| Chloride | GOST 31867-2012 | ≤1.0% w/w |
| Residual Proteins by Bradford Assay | Bradford Assay | ≤0.01% w/w |
| Residual Endotoxins | Ph Eur 2.6.14 | ≤10 EU/mg |
Footnotes
| [1] | Urashima, T., et al. (2009). Chemical characterisation of oligosaccharides in chimpanzee, bonobo, gorilla, orangutan, and siamang milk or colostrum. Glycobiology 19(5), 499-508 |
|---|---|
| [2] | HPAEC-HMO-007: Column: Carbopac PA200 (3 x 250 mm with 30 x 50 mm guard column); mobile phase: Water/100 mM NaOH + 125 mM sodium acetate/100 mM NaOH (isocratic); Flow rate: 0.4 mL/min; Column temperature 20°C |
| [3] | HPAEC-HMO-008: Column: Carbopac PA200 (3 x 250 mm with 30 x 50 mm guard column); mobile phase: Water/100 mM NaOH + 125 mM sodium acetate/100 mM NaOH/500mM NaOH (Gradient); Flow rate 0.4 mL/min; Column temperature 20°C |
Key to abbreviations
EPA = United States Environmental Protection Agency
EU = Endotoxin units
EN = European norms
GOST = Gosudarstvennyi standard
HPAEC = High-performance anion-exchange chromatography
ISO = International Organisation for Standardization
NMR = Nuclear magnetic resonance
Ph Eur = European Pharmacopoeia