Terpin Hydrate Click to View Image C10H20O2·H2O 190.28
p-Menthane-1,8-diol monohydrate [2451-01-6].
Anhydrous 172.27 [80-53-5]. »Terpin Hydrate contains not less than 98.0percent and not more than 100.5percent of C10H20O2,calculated on the anhydrous basis. Packaging and storage— Preserve in tight containers. USP Reference standards á11ñ USP Terpin Hydrate RS. Identification— A: Infrared Absorption á197Kñ:dried over a suitable desiccant for 4hours. B: Add a few drops of sulfuric acid to a hot solution:the liquid becomes turbid and develops a strongly aromatic odor. Water,Method Iá921ñ: between 9.0%and 10.0%. Residue on ignition á281ñ: not more than 0.1%. Residual turpentine— It has no odor of turpentine oil. Assay— Internal standard solution— Dissolve a quantity of biphenyl in chloroform to obtain a solution containing about 20mg per mL. Standard preparation— Transfer about 170mg of USP Terpin Hydrate RS,accurately weighed,to a 100-mLvolumetric flask,dissolve in 5mLof alcohol,add 5.00mLof Internal standard solution,dilute with chloroform to volume,and mix. Assay preparation— Transfer about 170mg of Terpin Hydrate,accurately weighed,to a 100-mLvolumetric flask,and proceed as directed under Standard preparation,beginning with “dissolve in 5mLof alcohol.” Chromatographic system— Under typical conditions,the gas chromatograph is equipped with a flame-ionization detector,and it contains a 3.5-mm ×1.2-m glass column packed with 6%G1on support S1A;the injection port and the detector temperatures are maintained at 260,and the column temperature at 120;and nitrogen is used as the carrier gas,at a flow rate necessary to yield approximate retention times of 7minutes for terpin and 11minutes for biphenyl. System suitability test— Chromatograph the Standard preparation,and record the chromatograms as directed for Procedure:the resolution,R,between the terpin and biphenyl peaks is not less than 2.0,and the relative standard deviation for replicate injections is not more than 2.0%. Procedure— Inject about 1µLof the Standard preparationinto a suitable gas chromatograph,and record the chromatogram.Similarly,inject about 1µLof the Assay preparation,and record the chromatogram.Calculate the quantity,in mg,of C10H20O2in the portion of Terpin Hydrate taken by the formula: WS(RU/RS), in which WSis the weight,in mg,of USP Terpin Hydrate RS,calculated on the anhydrous basis;and RUand RSare the area-ratios of terpin to the internal standard obtained from the chromatograms for the Assay preparationand the Standard preparation,respectively. Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist Expert Committee:(PA2)Pharmaceutical Analysis 2 USP28–NF23Page 1871 Phone Number:1-301-816-8143