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certificate of analysis
cetilistat 282526-98-1
batch no. | :20161226 | quantity | :50kgs | ||||||||
manuf. date | : 2016/12/26 | expiry date | : 2018/12/26 | ||||||||
analysis test | specifications | results | |||||||||
description | white or almost white crystalline powder | conforms | |||||||||
specific rotation | -48°~-51°(on the anhydrous, solvent -free basis ) | -49.3° | |||||||||
identification | the result of hplc is consistent to the reference one. | ||||||||||
the result of ir consistent to the reference one. | conforms | ||||||||||
water | ≤0.2% | 0.05% | |||||||||
related substances | |||||||||||
total impurity | ≤1.0% | 0.4% | |||||||||
individual unidentified inpurity | ≤0.1% | 0.02% | |||||||||
related compound a(by hplc) | ≤0.2% | conforms | |||||||||
related compound b(by gc) | ≤0.05% | nd | |||||||||
related compound c(by hplc) | ≤0.05% | conforms | |||||||||
formylleucine | ≤0.2% | conforms | |||||||||
open ring epimer | ≤0.2% | conforms | |||||||||
d-leucine | ≤0.2% | conforms | |||||||||
related compound d(by hplc) | ≤0.2% | conforms | |||||||||
open ring amide | ≤0.1% | conforms | |||||||||
related compound e(by hplc) | ≤0.2% | 0.09% | |||||||||
residual solvents | |||||||||||
methylene chloride | ≤100ppm | 20ppm | |||||||||
n-hexane | ≤1500ppm | 200ppm | |||||||||
methanol | ≤1000ppm | 30ppm | |||||||||
tetrahydrofuran | ≤720ppm | nd | |||||||||
hexane technical | ≤2000ppm | 80ppm | |||||||||
components(except n-hexane) | |||||||||||
total of n-hexane and heane | ≤3000ppm | 280ppm | |||||||||
technical components | |||||||||||
residyal on ignition | ≤0.1% | 0.08% | |||||||||
heavy metal | ≤20ppm | conforms | |||||||||
assay | 98.0%~101.5%(on the anhydrous,solvent -free | 99.8% | |||||||||
basis) |
conclusion: the product conforms with usp38