Efavirenz USP ≥98.0% made in china CAS NO.154598-52-4

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