CERTIFICATE OF ANALYSIS
Product Name | AlARELIN ACETATE | ||||
Batch No. | 20180519 | Mfg.Date | MAY.19.2018 | Analysis.Date | MAY.23.2018 |
Quantity | 85g | CAS | 79561-22-1 | Exp.Date | MAY.18.2020 |
Sequence | Glp-His-Trp-Ser-Tyr-D-Ala-Leu-Arg-Pro-NHEt | ||||
Storage | Store at 25 degree for transportation ,Store at 2~8 degree long term storage |
TEST | SPECIFICTIONS | TEST RESULTS |
Appearance | White or off-White powder | Complies |
Solubility | Sparingly soluble in MeOH ,soluble in water and 1% acetate acid | Complies |
Specific Optical Rotation | -46.0°~-56.0° (C=0.5%;1% acetate acid-anhydrous and acetic acid free subtance) | -53.8° |
Related Substances | Unspecified impurity for each impurity≤1.0% | 0.8% (Single largest impurity) |
Total impurity≤2.0% | 1.23% | |
Water Content | ≤5.0% | 3.2% |
Acetic acid Content | ≤7.5% | 6.9% |
MS | 1167.31±1.0 | 1166.8 |
Bacterial Endotoxins | ≤5.0 IU/mg | Complies |
Amino Acid Analysis | Arg 0.9~1.1 | Arg 1.0 |
His 0.9~1.1 | His 0.9 | |
Leu 0.9~1.1 | Leu 1.0 | |
Ala 0.9~1.1 | Ala 1.0 | |
Pro 0.8~1.0 | Pro 1.0 | |
Tyr 0.9~1.1 | Tyr 1.1 | |
Glu 0.9~1.1 | Glu 1.1 | |
Ser 0.7~1.0 | Ser 0.9 | |
No more than the traces of other amino acids are present | Complies | |
Residual Solvent | Methanol≤3000 ppm | 100ppm |
Acetonitrile≤410 ppm | 206ppm | |
Triethylamine≤320 ppm | 15ppm | |
Trifluoroacetic acid≤420 ppm | 105ppm | |
Assay | 95.0%~103.0% (Anhydrous and acetic acid free substance ) | 1002.0% |