CYAN340 is engineered to eliminate the systemic instability inherent in premixed retail copper peptide serums. Because aqueous copper tripeptide-1 degrades rapidly through hydrolysis when exposed to light, heat, and water, our formulations are produced under pharmaceutical-grade standards and preserved in an inert state until the moment of application.
1. Cleanroom & Lyophilization Specifications
Every batch of CYAN340 active vials is produced in an ISO 22716 and current Good Manufacturing Practice (cGMP) certified cleanroom. Active peptide solutions undergo sub-micron sterile filtration before filling. The vials are frozen and sublimated in an industrial freeze-drying chamber, removing all water while maintaining the delicate spatial conformation of the Gly-His-Lys copper tripeptide structure.
2. Analytical Release Testing (Per Batch)
No vial leaves our manufacturing partner without passing independent analytical testing documented on an official Certificate of Analysis (CoA):
- Reversed-Phase HPLC Purity: Must test at or above 99.0% pure (typical batch testing: 99.42%).
- Mass Spectrometry (ESI-MS): Confirms exact molecular mass at 340.38 ± 1.0 Daltons.
- Heavy Metal Screening (ICP-MS): Lead, arsenic, cadmium, and mercury must be non-detectable (< 0.1 ppm).
- Microbial Safety: Total aerobic microbial count (TAMC) below 10 CFU/g; zero pathogens.
3. Diluent Specification & Fresh-Dose Rationale
Our 10ml Isotonic Activator units consist of sterile, pyrogen-free mineral-balanced saline formulated to match physiological osmotic pressure. Reconstitution immediately prior to first use protects peptide chelation integrity, ensuring active molecules reach the skin before hydrolytic decay occurs.