Efavirenz API
≥98.0%
Conform to the USP.
We have GMP
Efavirenz
Appearance |
A White or almost white crystalline powder |
Identification |
IR spectra of sample exhibit similar with standard spectra UV spectra of sample exhibit similar with standard spectra |
Completeness of solution |
50mg/ML of efavirenz in methanol solvent ,clear |
Water |
≤0.5% |
Residue on ignition |
≤ 0.2% |
Heavy metals |
≤20ppm |
Enantiomer |
≤0.5% |
Related substance |
Impurity A ≤ 0.15% Impurity B ≤ 0.40% Impurity C、D、E ≤ 0.10% Impurity F ≤ 0.15% Impurity G ≤ 0.10% Impurity H ≤ 0.10% Impurity I ≤ 0.25% Impurity J ≤ 0.15% Impurity K ≤ 0.10% Impurity L ≤ 0.10% Impurity M ≤ 0.10% Impurity N ≤ 0.10% Impurity O ≤ 0.10% Impurity P ≤ 0.10% Any other individual impurity ≤ 0.10% Total impurities ≤ 1.0% |
Assay (on the anhydrous,solvent-free basis) |
98.0%~102.0% |
Residual organic sovents |
Ethanol ≤ 5000PPM Tetrahydrofuran ≤720PPM Toluene ≤890PPM |
Microbial limit |
Bacteria ≤1000CFU/g Molds & yeasts ≤100CFU/g E.coli N,D |
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