Sermorelin is an analogue of the naturally occurring human Growth Hormone–Releasing Hormone (GHRH). By stimulating the pituitary gland to release growth hormone (GH), it increases plasma growth hormone levels. Sermorelin binds to the growth hormone–releasing hormone receptor and promotes growth hormone secretion by mimicking the mechanism of action of native Growth Hormone–Releasing Factor (GRF). Sermorelin is primarily used in the treatment of growth hormone deficiency or growth failure in children.
Research Applications:
– Growth hormone secretion stimulation
– Growth hormone deficiency diagnosis
– Pediatric GHD treatment
| 项目 Items | 标准 Standard | 结果 Results | |
| 外观 Appearance |
白色或类白色粉末 White or off-white powder |
白色粉末 White powder |
|
| 分子量 Molecular Ion Mass |
3357.9±1.0 | 符合 Conforms |
|
| 溶解度 Solubility |
在纯水中可溶解至浓度为 5 mg/ml Can be dissolved to 5 mg/ml in pure water |
符合 Conforms |
|
| 酸碱度 pH |
4.0~7.0 | 4.8 | |
| 水分（K.F） Water Content (K.F) |
≤ 8.0% | 3.90% | |
| 纯度（UPLC） Purity (UPLC) |
≥ 99.0% | 99.20% | |
| 有关物质（UPLC） Related Substance (UPLC) |
总杂 Total impurities |
≤ 1.0% | 0.80% |
| 有关物质（UPLC） Related Substance (UPLC) |
最大单一杂质 Largest individual impurity |
≤0.5% | 0.33% |
| 残留溶剂（GC) Residual Solvent (GC) |
二氯甲烷 Methylene chloride |
≤ 600 ppm | 未检出 N.D |
| 乙腈 Acetonitrile |
≤ 410 ppm | 172 ppm | |
| 甲醇 Methanol |
≤ 3000 ppm | 未检出 N.D |
|
| N,N-二甲基甲酰胺 N,N-Dimethylformamide |
≤ 880 ppm | 未检出 N.D |
|
| 叔丁基甲醚 Isopropyl ether |
≤ 5000 ppm | 未检出 N.D |
|
| 酸根离子（IC） Acid Group Ions (IC) |
三氟乙酸 TFA |
≤ 0.1% | 未检出 N.D |
| 磷酸根 PO₄³⁻ |
≤ 0.1% | 未检出 N.D |
|
| 醋酸根 HAC |
≤ 10.0% | 7.80% | |
| 微生物限度 Microbial Limits |
需氧微生物总数 TAMC |
≤ 1000 cfu/g | 符合 Conforms |
| 酵母和霉菌总数 TYMC |
≤ 100 cfu/g | 符合 Conforms |
|
| 细菌内毒素 Bacterial Endotoxins |
≤ 10 EU/mg | 符合 Conforms |
|
| 含量测定（UPLC） Assay (UPLC) |
≥ 95.0% | 99.90% | |
| 储存 Storage |
保存至密闭容器中，避光保存，储存温度为 -20±5℃ Keep in tight container, protect from light, store at a temperature of -20±5℃ |
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