C8H8O3 152.15

Benzaldehyde,4-hydroxy-3-methoxy-.
Vanillin [121-33-5].

Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Vanillin RS.

Identification—

Melting range á741ñ: between 81and 83.

Loss on drying á731ñ— Dry it over silica gel for 4hours:it loses not more than 1.0%of its weight.

Residue on ignition á281ñ: not more than 0.05%.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Assay— Transfer about 100mg of Vanillin,accurately weighed,to a 250-mLvolumetric flask,add methanol to volume,and mix.Pipet 2mLof this solution into a 100-mLvolumetric flask,add methanol to volume,and mix.Dissolve an accurately weighed quantity of USP Vanillin RSin methanol,and dilute quantitatively and stepwise with methanol to obtain a Standard solution having a known concentration of about 8µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 308nm,with a suitable spectrophotometer,using methanol as the blank.Calculate the quantity,in mg,of C8H8O3in the portion of Vanillin taken by the formula: in which Cis the concentration,in µg per mL,of USP Vanillin RSin the Standard solution;and AUand ASare the absorbances of the solution of Vanillin and the Standard solution,respectively.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3104

Phone Number:1-301-816-8262