Evidence grade A
Research stage: Somatropin is the active ingredient of FDA-approved medicines such as Genotropin (BLA 020280); this PEPTYVA research vial is not one of those approved products.
Product description
HGH 10K is a 10 IU vial of somatropin, recombinant human growth hormone, made by PEPTYVA in Mexico and supplied for laboratory research use only. Approval of branded somatropin medicines does not extend to this research vial.
HGH 10K (Somatropin) 10 IU Research Vial
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Alternate name |
Somatropin; recombinant human growth hormone (rhGH); HGH |
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Compound class |
Recombinant protein hormone (191 amino acids) |
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Format |
Vial; physical form as stated on the PEPTYVA label |
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Strength(s) |
10 IU per vial (supplier listing). EU product information for somatropin states that 3.3 mg corresponds to 10 IU. |
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Sequence |
191 amino acids, identical to human growth hormone of pituitary origin (FDA label); full sequence in FDA GSRS, UNII NQX9KB6PCL |
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Molecular formula |
C990H1530N262O299S7 (estimated value, FDA GSRS) |
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Molecular weight |
22,124 Da (FDA-approved somatropin labeling) |
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CAS number |
12629-01-5 |
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Purity |
Stated per lot on the Certificate of Analysis |
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Manufacturer |
PEPTYVA, Mexico |
What is HGH 10K?
HGH 10K is a 10 IU vial of somatropin, the recombinant form of human growth hormone, made by PEPTYVA in Mexico. It is supplied for laboratory research use only, with a lot number for traceability. It is not a medicine and is not sold for use in people.
Somatropin is the international nonproprietary name for human growth hormone made by recombinant DNA technology. FDA labeling for approved somatropin describes a protein of 191 amino acid residues with a molecular weight of 22,124 daltons and an amino acid sequence identical to growth hormone of pituitary origin.
What does 10 IU mean?
10 IU is the amount of somatropin in each vial, expressed in international units. Growth hormone products are labeled in milligrams, in international units, or in both.
European product information for the somatropin medicine Omnitrope states that 3.3 mg of somatropin corresponds to 10 IU and that 5 mg corresponds to 15 IU, a ratio of 3 IU per mg. On that basis, a 10 IU vial corresponds to about 3.3 mg. The vial label and the lot Certificate of Analysis remain the reference for the actual content.
How is somatropin studied in research?
Somatropin is studied as the reference hormone of the growth hormone (GH) axis. Because its sequence matches pituitary growth hormone, it gives laboratories a defined protein with published identifiers: an international nonproprietary name, a CAS number (12629-01-5) and an FDA substance record (UNII NQX9KB6PCL).
FDA labeling for approved somatropin also tracks insulin-like growth factor I (IGF-I), a downstream marker of the GH axis. Research topics in this area include:
- Identity and purity testing of recombinant protein hormones
- Growth hormone receptor signaling in cell models
- The relationship between growth hormone and IGF-I in laboratory systems
- Comparison with GHRH analogs and secretagogues that act upstream at the pituitary
What does the current evidence show?
Somatropin has an established evidence base for defined indications, but only within specific branded medicines. FDA labeling lists Genotropin for "Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature" and for "Treatment of adults with either adult onset or childhood onset GHD".
That approval belongs to the branded product and does not extend to this PEPTYVA research vial. This page does not describe effects in people, and the vial is not intended for human use.
How does HGH 10K differ from other GH axis products?
HGH 10K contains growth hormone itself, while several neighboring products act upstream of it. Tesamorelin and sermorelin are GHRH analogs, and ipamorelin, GHRP-2 and GHRP-6 are growth hormone secretagogues studied for how they signal the pituitary.
Within the somatropin line, HGH 10K is the 10 IU presentation. The Somatropin product is a 15 IU vial of the same active ingredient from the same manufacturer.
What is the regulatory status of somatropin?
Somatropin is a regulated medicine ingredient in both the United States and Mexico. In the US, Genotropin is approved under biologics license application BLA 020280. In Mexico, the Ley General de Salud requires a registro sanitario for medicines (Article 376) and lists macromolecular hormones among products of biological origin (Article 229, fraction VIII).
Peptides Vallarta holds the license required to sell this product: [LICENSE DETAILS]. In sport, the World Anti-Doping Agency lists growth hormone as prohibited at all times.
Documentation
Each HGH 10K vial carries a PEPTYVA lot number. Request the Certificate of Analysis for your lot through our contact page before you order. A COA typically lists identity, purity, appearance, lot number and manufacturing and expiry dates.
Storage and handling
Keep the unopened vial in its original carton, away from light and heat, at the storage temperature printed on the PEPTYVA label. Check the label, seal and lot number on arrival, and contact us if the packaging arrives damaged.
Supplier statement (PEPTYVA). Supplier positioning, not verified by Peptides Vallarta.
Supplier statement pending.
Regulatory status
- United States
- Somatropin is FDA-approved only within specific branded medicines, such as Genotropin (BLA 020280), for labeled indications that include growth failure due to growth hormone deficiency in children and growth hormone deficiency in adults. This PEPTYVA research vial is not an FDA-approved product.
- Mexico (COFEPRIS)
- Under the Ley General de Salud, medicines require a registro sanitario (Article 376) and are sold under one of six dispensing categories (Article 226). Peptides Vallarta holds the license required to sell this product: [LICENSE DETAILS]. Approval of branded somatropin medicines does not extend to this research vial.
References
References pending.
Research use disclaimer
Research use only. This product is sold exclusively for laboratory research and in vitro analysis. It is not for human or veterinary use. It is not a medication, drug or medical device, and it is not intended to diagnose, cure or prevent any condition.
The buyer is responsible for safe handling, storage and disposal in line with applicable regulations.
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