Therapeutic Presets
FDA Reference Compounds
Peptide Primary Sequence
15 amino acids
Terminal mods: N-term H-, C-term -OH
15 AA
%
%
%
cGMP Batch Sizing
mg
vials
mL
mL
Batch specifications synchronized.
Molecular Weight
1,419.55
Da (Free Base Monoisotopic)
Isoelectric Point (pI)
4.85
Net Charge @ pH 7: -1.0
Total API Required
2.96 g
For 500 vials @ 84.5% net API
Formulation Osmolality
292 mOsm
Isotonic (USP <785>)
Primary Residue Map & Charge Profile
Click any residue to inspect hydropathy index, steric factor, and cleavage vulnerability.
GRAVY: -0.72 | A280 Ext: 0 Mâ»Â¹cmâ»Â¹
Basic (+) (K, R, H)
Acidic (-) (D, E)
Hydrophobic (A, V, L, I, M, F, W)
Polar Uncharged (S, T, N, Q, Y)
Special Structural (C, G, P)
Residue #1: Glycine (Gly, G) - Non-polar flexible anchor
MW: 57.05 Da | Hydropathy: -0.4 | pKa: N/A
cGMP Compounding Recipe (Bulk Solution)
| Component | Target Conc. | Per Batch (500 mL) |
|---|
*Includes +2.0% compounding overage for sterile 0.22 µm PES membrane holdup and filtration loss per FDA Guidance.
Finished Product Release Criteria (USP/ICH)
| Test Parameter | Acceptance Criteria | Compliance |
|---|---|---|
| Appearance / Cake | White to off-white lyophilized plug | Conforms |
| Identification (MS) | 1419.55 ± 1.0 Da | Pass |
| Purity (RP-HPLC) | ⥠98.0% (Single Max Imp ⤠1.0%) | ICH Q3A |
| Bacterial Endotoxin | < 5.0 EU/mg (USP <85>) | Pass |
| Residual TFA / Counterion | Acetate: 4.0 - 12.0% w/w | Pass |
| Sterility & Bioburden | No growth (USP <71> / <61>) | Pass |
Reconstitution Protocol & Dosing Syringe Calibration
Lyophilized Mass
5.0 mg / vial
Reconstitution Diluent
2.0 mL BAC Water
Delivered Concentration
2.50 mg / mL
U-100 Syringe (per 10 IU)
250 mcg / 10 units
Generated cGMP Master Batch Record (MBR)
Ready for QA validation, manufacturing batch run, and lot disposition sign-off.