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Name of the ingredient
Hesperidin (AAN)
Definition of the ingredient
(S)-7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one
Molecular formula: C28H34O15
Molecular mass: 610.56
CAS Number: 520-26-3
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Pale yellow - yellow green crystalline, hygroscopic powder |
| Characteristics | ||
| Solubility | BP (General notice) | Slightly soluble in water and methanol, soluble in solutions of alkali hydroxides |
| Melting point | BP (Appendix V A) | 258-262°C |
| Optical rotation | BP (Appendix V F) | -74° to -78° (in pyridine), calculated with reference to the dried substance |
| Water (determined on 0.100g) | BP (Appendix IX C, method 1) | Not more than 5.0% w/w |
| Identification | ||
| IR | BP (Appendix II A) | Spectrum matches that of the authenticated reference material |
| Assay | ||
| Hesperidin | HPLC | 98.0-102.0% (anhydrous basis) |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual solvents | BP (Appendix VIII L) | Complies |
| Incidental metals and non-metals | ||
| Heavy metals (as lead) | BP (Appendix VII) | Not more than 10 ppm |
| Other organic or inorganic impurities or toxins | ||
| Sulfated ash | BP (Appendix IX A) | Not more than 0.4% |
| Related substances | HPLC | Not more than 1.0% for oxedrine or any other individual impurity, and not more than 2.0% for total impurities |
| 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