1.0 Identification
| Common Name | BPC-157; Body Protection Compound-157 |
|---|---|
| CAS Number | 137525-51-0 |
| Molecular Formula | C62H98N16O22 |
| Molecular Weight | 1419.53 g/mol (monoisotopic: 1418.70 Da) |
| Sequence (single-letter) | Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val |
Amino acid sequence in extended one-letter notation:
BPC-157 is a synthetic pentadecapeptide (15 amino acids) whose sequence is derived from the alpha-chain of human gastric juice protein BPC.
2.0 Source
The peptide sequence was first reported by Sikirić et al. in the context of cytoprotective factors isolated from gastric juice [1]. BPC-157 represents residues 81–95 of the parent protein body protection compound.
3.0 Synthesis Notes
Nexphoria BPC-157 is manufactured by Fmoc solid-phase peptide synthesis (Fmoc-SPPS) on Rink amide resin, yielding a C-terminal amide. Coupling proceeds using HATU/DIPEA activation in N-methyl-2-pyrrolidinone (NMP).
| Synthesis Parameter | Value |
|---|---|
| Strategy | Fmoc-SPPS, stepwise assembly |
| Resin | Rink amide MBHA, 0.4–0.6 mmol/g loading |
| Coupling reagent | HATU / DIPEA, 3× molar excess per residue |
| Deprotection | 20% piperidine in DMF, 2 × 10 min |
| Cleavage cocktail | TFA:TIPS:H₂O (95:2.5:2.5 v/v), 2–3 h, RT |
| Purification | Preparative RP-HPLC, C18 column, 0.1% TFA gradient |
| Purity specification | ≥98% by analytical HPLC (UV 220 nm) |
| Final form | Lyophilized powder, acetate or TFA salt |
4.0 Stability
Stability data are derived from internal accelerated and real-time studies.
| Condition | Duration | Specification |
|---|---|---|
| Lyophilized, −20°C, dark | 24 months | ≥95% purity by HPLC |
| Lyophilized, 4°C, dark | 12 months | ≥95% purity by HPLC |
| Reconstituted, 2–8°C | 14 days | ≥90% purity; no visible turbidity |
| Reconstituted, −20°C (single freeze) | 30 days | ≥90% purity; minimize freeze-thaw cycles |
| Reconstituted, 25°C | 24 hours | Use within 24 h; discard if turbid |
5.0 Storage & Handling
Storage conditions follow USP <659> (Packaging and Storage Requirements). Lyophilized vials should be stored at −20°C in the original sealed vial, away from light.
| Packaging | Type I borosilicate glass vial, bromobutyl rubber stopper, aluminum crimp seal |
|---|---|
| Nitrogen atmosphere | Headspace purged with dry nitrogen prior to capping to retard oxidative degradation |
| Reconstitution solvent | 0.9% bacteriostatic sodium chloride or sterile water for injection; swirl gently, do not vortex |
| Recommended concentration | 0.5–2.0 mg/mL in reconstitution solvent |
| Handling | Avoid repeated freeze-thaw. Aliquot working volumes before freezing if extended use is anticipated. |
| USP reference | USP <659> Packaging and Storage Requirements; USP <1> Injections and Implanted Drug Products (context only) |
6.0 Analytical Methods
Lot release testing includes the following analytical determinations. Full method parameters are documented in the Nexphoria HPLC Method Note (NX-MN-001).
| Test | Method | Acceptance Criterion |
|---|---|---|
| Purity | RP-HPLC, C18 (4.6×250 mm, 5 µm), UV 220 nm, 0.1% TFA gradient | ≥98% (area percent, main peak) |
| Identity | ESI-MS, positive mode; theoretical [M+H]⁺ = 1420.5 Da | Observed mass within ±0.5 Da of theoretical |
| Appearance | Visual inspection under daylight-equivalent illumination | White to off-white lyophilized powder; no visible particulates |
| Moisture | Karl Fischer titration, USP <921> | ≤6.0% w/w |
| Endotoxin | LAL kinetic-chromogenic, USP <85> | ≤0.5 EU/mg |
Identity confirmation by HPLC alone is insufficient; mass spectrometric confirmation is required for each production lot.
7.0 References
- [1] Sikirić P. et al. (2012). Stable gastric pentadecapeptide BPC-157. Current Pharmaceutical Design, 17(16):1604–1617. DOI:10.2174/138161211796197208
- [2] Manning M.C. et al. (2010). Stability of protein pharmaceuticals. Pharmaceutical Research, 27(4):544–575. DOI:10.1007/s11095-009-0045-6
- [3] Gu Y. et al. (2009). Asp-Pro peptide bond cleavage kinetics. Journal of Peptide Science, 15(3):211–218. DOI:10.1002/psc.1084
- [4] Rozenski J. et al. (1999). The RNA Modification Database: 1999 update. Nucleic Acids Research, 27(1):196–197. DOI:10.1093/nar/27.1.196
- [5] Sewald N., Jakubik H.D. (2009). Peptides: Chemistry and Biology, 2nd ed. Wiley-VCH. ISBN:978-3527315222.
- [6] Stipančević T. et al. (2019). Pentadecapeptide BPC-157 characterization. Current Medicinal Chemistry, 26(1):1–17. DOI:10.2174/0929867325666180917165148
- [7] USP (2024). USP <659> Packaging and Storage Requirements.
- [8] USP (2024). USP <85> Bacterial Endotoxins Test.