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Name of the ingredient
Ribose (AAN)
Synonyms: D-ribose
Definition of the ingredient
D-Ribose is a pentose, monosaccharide sugar
IUPAC name: (3R,4S,5R)-5-(hydroxymethyl)oxolane-2,3,4-triol
Molecular formula: C5H10O5
Molecular mass: 150.13 g/mol
CAS Number: 50-69-1
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White to slightly yellow powder |
| Characteristics | ||
| Solubility | BP (General notices) | freely soluble in water |
| Clarity of solution | BP (Appendix IV A) | clear |
| Loss on Drying | BP (Appendix IX D) | Not more than 0.5% w/w |
| Identification | ||
| Infra-red spectrum | BP (Appendix II A) | Complies with authenticated reference material/spectrum |
| Specific optical rotation (1 g/mL in water, 20 °C, 10 cm path length) | BP (Appendix V F) | -19.0 ° to -21.0 ° |
| Assay | ||
| Assay | GC post column derivatisation | 98% to 102% w/w, on dried basis |
| Sulphated Ash | BP (Appendix XI J) | 0.2% w/w |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual Solvents | BP 2015 (Appendix VIII L) | Meets the requirements of the BP |
| Incidental metals and non-metals | ||
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary general chapter '<2232> Elemental Contaminants in Dietary Supplements'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| Other organic or inorganic impurities or toxins | ||
| Related substances | BP General Notices for 'Substances for Pharmaceutical use' | Complies |
| Microbiology | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
BP = British Pharmacopoeia
GC = Gas chromatography
IR = Infrared spectrophotometry