Red Chem Biotech Private Limited
CIN U74120UP2015PTC074606
- Document:
- RCB-PIS-SOMATROPIN-RHGH
- Generated:
- 2026-10-10
Product information sheet
Somatropin (rhGH)
Recombinant human growth hormone identity record.
Product summary for procurement. The specification, Safety Data Sheet and batch Certificate of Analysis are supplied as separate documents. Not medical advice.
1. Identity
| Product name | Somatropin (rhGH) |
|---|---|
| Synonyms | Somatropin (INN), Recombinant human growth hormone, rhGH, hGH (191 aa) |
| CAS number | 12629-01-5 |
| Molecular formula | C990H1528N262O300S7 |
| Molecular weight | Approximately 22,125 Da (reference literature value) |
| Product type | Recombinant protein (human growth hormone, 191 amino acids) |
| Category | Pharmaceutical Ingredients |
| Identity testing | Confirmed for every batch on the Certificate of Analysis |
Somatropin is recombinant human growth hormone: a single-chain 191-amino-acid polypeptide with two disulfide bridges, produced by recombinant expression and described in public reference sources as sequence-identical to pituitary-derived human growth hormone. As a biological substance, identity and quality assessment depends on far more than a nominal purity figure: relevant attributes include primary structure confirmation, higher-order structure, charged and size variants, host-cell protein and host-cell DNA residuals, biological potency in international units, endotoxin, sterility, and container-closure integrity, each defined by a compendial or agreed specification. In most jurisdictions somatropin is a prescription biological product whose manufacture, import and supply require specific authorisation. This record documents identity only. Red Chem Biotech publishes no potency, purity, sterility, or batch documentation for it.
2. Quality and handling
| Purity | ≥99.0% (HPLC) |
|---|---|
| Physical form | Stated on the Certificate of Analysis. |
| Storage | Stated on the Safety Data Sheet and Certificate of Analysis supplied with each batch. |
| Packaging | Sealed, labelled containers suited to the order quantity; confirmed on your quotation. |
3. Test parameters
| Appearance (Visual) | Conforms |
|---|---|
| Identity (Peptide mapping / intact mass) | Conforms |
| Purity (monomer) (SEC-HPLC) | ≥ 99.0 % |
| Related proteins (RP-HPLC) | Per specification |
| Potency (Bioassay or validated physicochemical assay) | Per specification |
| Protein content (UV A280 or HPLC) | Per specification |
| Host cell protein (ELISA) | Per specification |
| Bacterial endotoxins (LAL) | Per specification |
| Water content (Karl Fischer) | Per specification |
| Bioburden (Ph. Eur. 2.6.12) | Per specification |
Batch results are reported on the Certificate of Analysis supplied with each order.
4. Regulatory information
| Classification | Supplied with buyer declaration |
|---|---|
| Status notes | Prescription / Jurisdiction Dependent |
| Enquiry handling | Online quote; buyer declaration checked at payment |
5. Documentation
| Product specification | Prepared for you and released to your private enquiry page on request |
|---|---|
| Certificate of Analysis (COA) | Issued for your batch and shipped with the order |
| Safety Data Sheet (SDS) | Prepared for you and released to your private enquiry page on request |
| Analytical data (chromatograms / spectra) | Prepared for you and released to your private enquiry page on request |
| Method of analysis (MOA) | Prepared for you and released to your private enquiry page on request |
| TSE/BSE statement | Prepared for you and released to your private enquiry page on request |
| Stability and storage statement | Prepared for you and released to your private enquiry page on request |
| End-use / end-user declaration | Prepared for you and released to your private enquiry page on request |