Name of the ingredient
D-Ribose-L-Cysteine (AAN)
Definition of the ingredient
Molecular formula: C8H15NO6S
CAS Number: 17087-36-4
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White to pale yellow powder |
| Characteristics | ||
| pH (0.5 g in 10 ml water) | USP <791> | 3.0 - 4.0 |
| Solubility | BP (General notices) | Freely soluble in water; practically insoluble in ethanol and acetone |
| Clarity of solution (0.5 g in 10 ml water) | BP (Appendix IV A) | Clear |
| Loss on Drying | BP (Appendix IX D) | Not more than 0.5% w/w |
| Specific optical rotation (1.0 g per 100 ml) | USP <781> | -125º ±6º |
| Identification | ||
| D-Ribose-L-Cysteine |
IR absorbance spectrum BP (Appendix II A) |
Complies with authenticated reference material/spectrum |
| D-Ribose-L-Cysteine | HPLC | Complies with the chromatogram for the authenticated reference material |
| Assay | ||
| Assay | HPLC | 98.0 to 102.0% w/w, on dried basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual solvents | BP (Appendix VIII L) | Meets the requirements of the BP Supplementary Chapter SC IV D |
| 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 | HPLC |
L-cysteine not more than 1.0% w/w L-cystine not more than 1.0% w/w Any other individual impurity not more than 0.15%w/w. Total impurities (other than L-cysteine and L-cystine) not more than 0.5%w/w |
| 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
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
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