99%: 外观Appearance 黄色至橙色粉末 核磁Proton NMR spectrum Conforms 纯度Purity ≥99.0% (HPLC,面积归一法) 比旋光度Specific rotation [a]20/D +19.0 ~ +24.0 °(C=0.1,1N NaOH) 硫酸盐灰分sulfated ash ≤0.1% 水分Water ≤10.0 % 品级Grade USP级 (EP, USP testing specifications) 鉴别试验Identity Pass by UV (In Acid and Base) 鉴别试验Identity Pass by IR 比旋度Specific Rotation (anhydrous) 19 - 24 ° 水分Water (by Karl Fischer) ≤12.0 % 灼烧残渣Residue on ignition (Ash) ≤0.1 % 重金属Heavy Metal ≤50 ppm 相关化合物Related Compounds Pass 相关物质Related Substances Pass (R)-甲氨蝶呤(R)- Methotrexate ≤3.0 % 含量Assay(Anhydrous basis) 98.0 - 102.0 % 残留溶剂Residual Solvents Meets Requirements
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