Sermorelin Acetate Injection contains sermorelin as the active ingredient, a synthetic polypeptide with CAS No.: 86168-78-7 and MF: C149H246N44O42S. Corresponding to the amino-terminal 29-amino acid fragment of endogenous human growth hormone-releasing hormone (GHRH), it can stimulate the pituitary gland to secrete growth hormone. Formulated as a sterile, pyrogen-free lyophilized powder, it requires reconstitution before subcutaneous injection.
Clinically, it is used for diagnostic evaluation of pituitary function and treatment of short stature due to growth hormone deficiency in children. Store under refrigeration (-20℃) and use as prescribed. Common adverse reactions are mild, such as injection site pain and transient facial flushing.It is contraindicated in patients with hypersensitivity to any component of the formulation or active tumors.
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Sermorelin COA
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| Certificate of Analysis | ||
| Compound name | Sermorelin | |
| Grade | Pharmaceutical grade | |
| CAS No. | 86168-78-7 | |
| Quantity | 15g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202512090051 | |
| MFG | Dec 9th 2025 | |
| EXP | Dec 8th 2028 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.54% |
| Loss on drying | ≤1.0% | 0.42% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.90% |
| Single impurity | <0.8% | 0.52% |
| Total microbial count | ≤750cfu/g | 95 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 500ppm |
| Storage | Store in a sealed, dark, and dry place below -20°C | |
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| Chemical Formula | C149H246N44O42S | |
| Exact Mass | 3355.82 | |
| Molecular Weight | 3357.93 | |
| m/z | 3356.82(100.0%), 3357.83(80.0%), 3355.82(62.1%), 3358.83(35.2%), 3357.82(16.3%), 3358.82(13.0%), 3356.82(10.1%), 3359.83(10.0%), 3358.83(8.6%), 3358.83(7.3%), 3359.83(6.9%), 3359.83(6.7%), 3359.83(5.7%), 3357.82(5.4%), 3358.82(4.5%), 3359.82(3.6%), 3360.84(3.2%), 3360.83(3.0%), 3357.83(2.8%), 3357.81(2.8%), 3358.83(2.3%), 3360.84(2.1%), 3356.82(1.8%), 3360.83(1.6%), 3357.83(1.6%), 3360.82(1.6%), 3361.84(1.4%), 3359.82(1.4%), 3358.82(1.3%), 3358.83(1.3%), 3359.83(1.2%), 3360.83(1.1%), 3360.83(1.1%), 3361.84(1.0%), 3359.82(1.0%) | |
| Elemental Analysis | C,53.30; H,7.38; N,18.35; O,20.01; S,0.95 | |
Mechanism of Action of it Injection for Pituitary Function Diagnosis
To understand the application value of it in pituitary function diagnosis, it is necessary first to clarify its core mechanism of action. Endogenous growth hormone-releasing hormone (GHRH) is secreted by the hypothalamus; it can specifically bind to receptors on the surface of growth hormone-secreting cells in the anterior pituitary, activate intracellular signaling pathways, and thereby stimulate the synthesis and release of growth hormone. The main component of it is sermorelin, a bioactive fragment analog of GHRH, which can accurately mimic the physiological functions of endogenous GHRH by specifically binding to receptors on pituitary growth hormone-secreting cells, with an affinity comparable to that of endogenous GHRH.
During the diagnostic evaluation process, subcutaneous injection of it provides exogenous supplementation of GHRH bioactive fragments, exerting specific stimulation on pituitary growth hormone-secreting cells. In this context:
If pituitary function is normal, growth hormone-secreting cells will release growth hormone in response to drug stimulation, leading to a regular increase in serum growth hormone levels.
If there are defects in pituitary growth hormone secretory function (e.g., reduced cell number, decreased receptor sensitivity), the response to drug stimulation will be attenuated or absent, and serum growth hormone levels will fail to reach the normal elevation range.
By monitoring changes in serum growth hormone concentrations at different time points after drug injection, the status of pituitary growth hormone secretory function can be accurately determined, providing objective and reliable evidence for clinical diagnosis.
Compared with other non-specific stimulants, it features a highly specific mechanism of action: it acts exclusively on pituitary growth hormone-secreting cells without producing significant interference with other hormone-secreting cells in the pituitary or other organs throughout the body, thus ensuring the accuracy and specificity of diagnostic results.
Clinical Application Process of it in Diagnostic Evaluation of Pituitary Function
The use of Sermorelin Acetate Injection for pituitary function diagnostic evaluation must follow a standardized clinical process to ensure the reliability and comparability of test results. The specific process mainly includes four core stages: preoperative preparation, drug injection, sample collection and testing, and result interpretation.
(I) Preoperative Preparation
Preoperative preparation is the foundation for ensuring diagnostic accuracy, consisting mainly of patient assessment and preparation, and drug preparation.
Patient Assessment and Preparation
A detailed medical history and past medication history (especially drugs affecting endocrine function, such as glucocorticoids and thyroid hormones) should be collected from the patient, accompanied by a basic physical examination.
The patient must fast for 8–12 hours before the test to avoid interference of dietary components such as protein and sugar with growth hormone levels.
The patient should maintain quiet rest for more than 30 minutes before the test to prevent physiological elevation of growth hormone caused by factors such as emotional agitation and strenuous exercise, which may affect test results.
Drug Preparation
The product is formulated as a sterile, pyrogen-free lyophilized powder and requires reconstitution before use.
Reconstitution must be performed in strict accordance with operating procedures: use sterile water for injection or normal saline as the solvent, add it slowly to the powder, and gently swirl to dissolve; avoid violent shaking, which may reduce drug activity.
Reconstituted drugs should be used immediately. If not used temporarily, they should be stored at 2–8℃ under refrigeration for no more than 24 hours. Unreconstituted lyophilized powder must be stored at -20℃ under refrigeration, and repeated freezing and thawing is strictly prohibited.
(II) Drug Injection
The drug is administered via subcutaneous injection, typically at sites with loose skin and abundant blood supply such as the abdomen and lateral thigh, to ensure rapid and uniform drug absorption. Strict aseptic operation must be performed during injection to avoid infection; the injection speed should be slow to reduce the occurrence of local adverse reactions such as pain and redness at the injection site.
(III) Sample Collection and Testing
The core of sample collection is to monitor changes in serum growth hormone concentrations at different time points after drug injection.
Venous blood is usually collected before injection as a baseline sample for growth hormone levels.
Subsequent venous blood samples are collected at 15, 30, 60, 90, and 120 minutes after injection.
Collected blood samples must be sent for testing promptly, and growth hormone concentrations are measured using precise detection methods such as chemiluminescent immunoassay. The testing process must comply with laboratory operating standards to ensure the accuracy and repeatability of test results.
(IV) Result Interpretation
The core criterion for result interpretation is to determine the peak concentration and elevation amplitude of serum growth hormone after injection of Sermorelin Acetate Injection. Clinical consensus holds that:
A peak growth hormone concentration ≥ 10 ng/mL after injection indicates normal pituitary growth hormone secretory function.
A peak concentration ＜ 5 ng/mL suggests severe impairment of pituitary growth hormone secretory function.
A peak concentration between 5–10 ng/mL implies partial impairment of pituitary growth hormone secretory function, requiring further clarification of the diagnosis by combining the patient's clinical symptoms and other test results (e.g., insulin-like growth factor-1 (IGF-1) level detection).
In addition, attention should be paid to the growth hormone concentration curve. Under normal circumstances, growth hormone concentrations reach peak levels 30–60 minutes after injection and then gradually decline. The absence of an obvious peak or delayed peak time in the curve also indicates potential pituitary dysfunction.
Precautions for Diagnostic Application of it
To ensure the accuracy and safety of the diagnostic application of it, the following precautions should be noted during clinical use:
Strictly Exclude Contraindicated Patients:
The drug is contraindicated in patients allergic to any component of it, those with active tumors (especially pituitary tumors), and patients with severe hepatic or renal insufficiency. This is to avoid severe adverse reactions or disease exacerbation caused by drug administration.
Pay Attention to Drug Interactions:
If the patient is using drugs that affect endocrine function (e.g., glucocorticoids, thyroid hormones), the drugs should be discontinued 3–7 days before the test to prevent interference with pituitary growth hormone secretory function and inaccurate diagnostic results. At the same time, inform the patient to avoid using growth hormone, GHRH, and other related drugs before the test to ensure the stability of the testing environment.
Standardize Drug Storage and Reconstitution Operations:
Unreconstituted lyophilized powder must be strictly stored at -20℃ under refrigeration. Reconstituted drugs should be used promptly to prevent reduced drug activity due to improper storage, which may affect the stimulation effect. During reconstitution, use the specified solvent, strictly control the solvent volume and dissolution method to ensure complete dissolution of the drug without precipitation.
Strengthen Patient Monitoring During the Test:
Despite the high safety profile of the drug, it is necessary to closely monitor the patient's vital signs and clinical symptoms during the test. If severe adverse reactions occur (e.g., severe allergic reactions, persistent dizziness and vomiting), the test should be stopped immediately, and corresponding first-aid measures should be taken.
FAQ
1.What is it used for?
It was FDA-approved to treat growth hormone deficiency in children when researchers discovered it could stimulate the pituitary gland to pump out more HGH. However, it's now frequently prescribed off-label-as a daily injectable-to promote growth hormone production in older men and women.
2.What are the negative effects of it?
It use can cause several adverse effects. Many users report swelling and edema (fluid build-up) in the arms, legs, and face. Users also report joint and nerve pain. Additionally, Sermorelin-induced GH excess can contribute to insulin resistance, increasing the risk of developing diabetes.
3.How to inject it?
Typically, you would inject it once a day at bedtime. The process involves using an insulin-style syringe to inject a small volume (often 0.5 mL or less) into a spot like your lower abdomen or thigh.
4.What are the risks of it?
It peptides typically only need to be given every 5 days as a subcutaneous injection (followed by 2 days off). The dosage is typically increased over time as the weeks progress. The exact amount of dosage given will depend on your specific health, weight, and needs.
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