3-氮杂双环[3.1.0]己烷-2-甲酰胺，n-[（1s）-1-氰基-2-[（3s）-2-氧代-3-吡咯烷基]乙基]-3-[（2s）-3,3-二甲基-1-氧代-2-[（2,2,2-三氟乙酰基）氨基]丁

外观

Physical appearance

白色、类白色粉末

White、or off-white powder

白色粉末

White powder

识别

Identify

核磁确认与供试样品保持一致

NHR confirmation is consistent with the test sample

与样品一致

Conformed

液相出峰保留时间与供试样品保持一致

The peak time of HPLC is consistent with the test sample

与样品一致

Conformed

有关物质

Related substances  

高效液相色谱纯度≥99.50% Purity of HPLC≥99.50%

99.85%

其他未知单杂≤0.10%  Any Individual Impurity≤0.20%

0.03%

总杂质≤0.50%   Total impurity≤≤0.50%

0.15%

手性纯度

Chiral Purity

手性纯度≥99.9%

NLT 99.9%

合格

Conforms

含量

Assay by HPLC

98.00%~102.00%

99.58%

灼烧残渣

Ignition residue

≤0.30%

0.03%

重金属

Heavy Metals

≤20ppm

未检出/N.D

残留溶剂

Solvent residue

甲醇≤300ppm/Methanol≤300ppm

未检出/N.D

丙酮≤500ppm

未检出/N.D

乙腈≤41ppm/Acetonitrile≤41ppm

3ppm

二氯甲烷≤60ppm/Dichloromethanes60ppm

12ppm

异丙醚≤500ppm/sopropyl Ether≤500pppm

未检出/N.D

乙酸乙酯≤500ppm/Ethyl Acetates500ppm

17ppm

四氢呋喃≤72ppm/Tetrahydrofuran≤72ppm

未检出/N.D

醋酸异丙酯≤40ppm/Isopropyl acetate≤40ppm

22ppm

乙醇≤300ppm/Methanol≤300ppm

6ppm

水份/Water

≤0.50%

0.26%

内毒素/Bacterial Endotoxin

NMT0.5EU Per Mg

Conforms

微生物

Microbial Limit

Total amount of aerobe:NMT1000cfu/g

Conforms

Yeast&molds: NMT 100cfu/g

Conforms

结论/Detection result

合格/Qualified