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Compositional guideline: Ribose

22 September 2015

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

Table 1. Ingredient specific requirements
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
Table 2. Incidental constituents
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