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Compositional guideline: Hesperidin

15 July 2013

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

Table 1: Ingredient specific requirements
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)
Table 2: Incidental constituents
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