Certification: | GMP |
---|---|
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Almost White Crystalline Powder |
Volatile: | Not Volatile |
Transport Package: | Drum |
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Items | Standard |
Characters | A white to slightly pink crystalline powder,Soluble in methanol,practically insoluble in water. |
Identification | IR:Infrared absorption spectrum should comply with that of efavirenz reference substance. |
UV:Ultraviolet absorption spectrum should comply with that of reference substance. | |
Polymorphic identify:XRD spectrum should be comparable to the standard | |
Completeness of Solution | The substance with a concentration of 50 mg/mL in methanol can be completely solube. |
water content | ≤0.5% |
Residue on ignition | ≤0.2% |
Enantiomer | ≤0.5% |
Related substances Impurity A Impurity B Impurity C Impurity D Impurity E Impurity F Impurity G Impurity H Impurity I Impurity J Impurity K Impurity L Impurity M Impurity N Impurity O Impurity P Any other individual impurity Total impurities |
≤0.15% ≤0.40% ≤0.10% ≤0.10% ≤0.10% ≤0.15% ≤0.10% ≤0.10% ≤0.25% ≤0.15% ≤0.10% ≤0.10% ≤0.10% ≤0.10% ≤0.10% ≤0.10% ≤0.10% ≤1.0% |
*Parachloroaniline | ≤2.5ppm |
Assay(on anhydrous,solvent-free basis) | 98.0%~102.0% |
(GC)Residual organic solvents Ethabol Toluene Tetrahydrofuran Benzene |
≤5000ppm ≤890ppm ≤720ppm ≤2ppm |
*Butyl chloride | ≤2.5ppm |
*Bioburden Total aerobic microbial count Total yeast and mold E.coli |
≤1000CFU/g ≤100CFU/g Absent/g |
*Metallic element V Co Ni As Cd Hg Pb |
≤10ppm ≤5ppm ≤20ppm ≤1.5ppm ≤0.5ppm ≤3ppm ≤0.5ppm |
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