| Appearance (EP, BP) |
Yellow to orange-yellow crystalline powder |
| Appearance (JP) |
Yellow to orange-yellow crystals |
| Appearance (USP) |
Yellow to orange-yellow crystalline powder |
| Appearance (IP) |
Yellow to orange-yellow crystalline powder |
| Solubility (EP, BP) |
Very slightly soluble in water, practically insoluble in ethanol (96%) |
| Solubility (USP) |
Soluble in dilute solution of alkalies; very slightly soluble in water, in alcohol, and in isotonic sodium chloride solution; insoluble in ether and in chloroform |
| Solubility (JP) |
Very slightly soluble in water, practically insoluble in ethanol (95%), in acetic acid (100), and in diethyl ether. It dissolves in sodium hydroxide TS |
| Solubility (IP) |
Very slightly soluble in water, more soluble in saline solution than in water; practically insoluble in chloroform, in ethanol (95%) and in ether. |
| Identification A: Colour and fluorescence of solution (USP) |
The sample solution is pale greenish yellow by transmitted light. By reflected light, it exibits an intense yellowish green fluorescence that disappears upon the addition of mineral acids and alkalies |
| Identification A: Specific optical rotation (EP, BP) |
-135.00° to -115.00° (c = 0.50% in 0.05M NaOH, at 20 ± 0.5°C, dried substance, measure the rotation within 30 min. of dissolution) |
| Identification A : FTIR (IP) |
Matches with the standard pattern |
| Identification B : TLC (EP, BP) |
The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution. |
| Identification B (IP) |
A pale greenish yellow colour by transmitted light and an intense yellowish green fluorescence by reflected light, which disappears on addition of mineral acids or alkalis |
| Identification C (EP, BP) |
The solution has, by transmitted light, a pale greenish yellow colour, and, by reflected light, an intense yellowish-green fluorescence which disappears on the addition of mineral acids or alkalis. |
| Identification 1 (JP) |
The fluorescence disappears upon the addition of dilute hydrochloric acid or sodium hydroxide TS |
| Identification 2 (JP) |
The chloroform layer shows a yellow-green fluorescence. |
| Identification 3 (JP) |
Both spectra exhibit similar intensities of absorption at the same wavelengths. |
| Melting point (JP) |
about 290°C (with decompositions) |
| pH (Saturated aqueous solution) : (IP) |
5.50 - 7.20 |
| Specific rotation (USP, IP) |
-135.00° to -115.00° (c = 0.50% in 0.05M NaOH, measure the rotation within 30 min. of dissolution, use dry substance) |
| Specific rotation (EP, BP) |
-135.00° to -115.00° (c = 0.50% in 0.05M NaOH, at 20 ± 0.5°C, dried substance, measure the rotation within 30 min. of dissolution) |
| Optical rotation (JP) |
-142.00° to -128.00° (c = 0.50% at 20°C, 0.1 g of dried Riboflavin, dissolve in 4 mL of dilute NaOH TS, add 10 mL water, add 4 mL of aldehyde-free ethanol and dilute with water to make 20 mL, measure the rotation within 30 min. after preparing the solution) |
| Light Absorbance 1 at A373/A267 : (IP) |
0.31 to 0.33 |
| Absorbance ratio 1 at A373/A267 : (EP, BP) |
0.31 to 0.33 |
| Light Absorbance 2 at A444/A267 : (IP) |
0.36 to 0.39 |
| Absorbance ratio 2 at A444/A267: (EP, BP) |
0.36 to 0.39 |
| Related substance, system suitability, HPLC: Resolution (EP, BP) |
>= 5.0 between the peak due to impurity A and B in the chromatogram obtained with reference solution (C) |
| Related substances 1: Impurity A : HPLC (EP, BP) |
<= 0.025% |
| Related substances 2: Impurities B, C, D for each impurity: HPLC (EP, BP) |
<= 0.20% |
| Related substances 3: Unspecified impurities for each impurity: HPLC (EP, BP) |
<= 0.10% |
| Related substances 4: Total impurities: HPLC (EP, BP) |
<= 0.50% |
| Loss on drying (at 105°C, 2h) : (USP, EP, BP, JP, IP) |
<= 1.50% |
| Residue on ignition (USP) |
<= 0.30% |
| Residue on ignition (JP) |
<= 0.20% |
| Sulfated ash (EP, BP, IP) |
<= 0.10% |
| Limit of Lumiflavin (by UV, USP) |
<= 0.025 |
| Lumiflavin (JP) |
The filtrate has no more color than the control solution. (Control solution: To 2.0 mL of 1/60 mol/L potassium dichromate VS add water to make 1000 mL.) |
| Lumiflavin (IP) |
The filtrate is not more intensely colored than reference solution BYS6 |
| Assay (UV, on dry basis) : (JP) |
min. 98.00% |
| Assay (UV, on dry basis) : (USP) |
98.00 - 102.00% |
| Assay (UV, on dry basis) : (EP, BP) |
97.00 - 103.00% |
| Assay (UV, dried basis) : (IP) |
98.00 - 101.00% |