Name of the ingredient
Quercetin dihydrate (AAN)
Definition of the ingredient
2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one
Molecular formula: C15H10O7.2H2O
Molecular mass: 338.2 (302.24 for anhydrous)
CAS Number: 6151-25-3
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Yellow crystals or yellowish powder |
| Solubility | BP (General notice) | Practically insoluble in water, slightly soluble in absolute alcohol, soluble in aqueous solutions of alkali |
| Water (determined on 0.100g) | BP (Appendix IX C, method 1) | 9.0%-12.0% |
| Perform either the IR test or both TLC and HPLC tests as below | ||
| IR | BP (Appendix II A) | Spectrum matches that of the authenticated reference material |
| TLC | BP (As prescribed in the monograph for Ginkgo Leaf); Ph Eur monograph 1828 | The principal spot in the chromatogram obtained with the test solution corresponds to that obtained with the solution of the reference material Note: This test must be done in conjunction with HPLC |
| HPLC | BP (Appendix III D) | The retention time of the principal peak in the chromatogram of the test solution matches that of the solution of the authenticated reference material |
| Quercetin | HPLC | 98.0-102.0% w/w (anhydrous basis) |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Incidental metals and non-metals | ||
| Other organic or inorganic impurities or toxins | ||
| Microbiology | ||
| Residual solvents | BP (Appendix VIII L) | Complies |
| Heavy metals (as lead) | BP (Appendix VII) | Not more than 10 ppm |
| Sulfated ash | BP (Appendix IX A) | Not more than 0.2%
|
| Related substances | HPLC | Not more than 1.0% for any individual impurity, 2.0% for total impurities |
| 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
TLC = Thin layer chromatography
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