Erythromycin Ethylsuccinate, Certificate of Analysis, USP30 Edition,
|
Item |
Standard(USP30) |
Test Result |
|
Appearance |
White powder or crystalline powder |
White powder |
|
Identification |
IR |
Conform |
|
Crystallinity |
Meets the requirements |
Conform |
|
X-ray diffraction |
Meets the requirements |
Conform |
|
Water |
≤3.0% |
1.4% |
|
Residue on ignition |
≤1.0% |
0.2% |
|
Related Compounds |
Erythromycin B ≤3.0% |
1.2% |
|
Erythromycin C ≤3.0% |
1.0% |
|
Erythromycin A enol ether ≤3.0% |
1.0% |
|
Erythromycin N-ethylsuccinate ≤3.0% |
1.1% |
|
Any individual related compound ≤3.0% |
0.6% |
|
Residual Solvents |
THF: ≤720ppm |
288ppm |
|
Assay |
≥76.5% |
77.5% |
