Batch Report
R3TA 10
3.33 mg/mL · 3 mL Cartridge · 10 mg · Lot 20260604-RT10A
Batch Information
Lot20260604-RT10A
Manufacture Date2026-06-04
Concentration3.33 mg/mL
Fill Volume3.2 mL (3 mL deliverable)
Strength10 mg per cartridge
Storage2–8 °C · Protect from light
Final pH (post-filtration)7.20
Formulation per 3 mL Cartridge
R3TA10 mg
Sodium Phosphate5 mM
Glycerol2.2% w/v
Phenoxyethanol0.7% v/v
Polysorbate 200.02% w/v
Water for Injectionq.s. to 3.2 mL
Batch Preparation — 50 mL Bulk
R3TA (actual weighed)176.6 mg
Phosphate Buffer Stock (100 mM)2.5 mL
Glycerol1.10 g
Phenoxyethanol0.35 mL
Polysorbate 20 (1% stock)1.0 mL
Water for Injectionq.s. to 50 mL
API Quality — Potency & Purity
| Parameter | Reference | Limit | Result | Status |
|---|---|---|---|---|
| Assay (Anhydrous, Sodium-Free Basis) | USP ⟨1000⟩, EP 2.7.1 | 98.0–102.0% | 101.1% | Pass |
| HPLC Purity | Industry peptide standard | ≥98.0% | 99.5% | Pass |
| Total Impurities | ICH Q3A | ≤2.0% typical | 0.5% | Pass |
| High Molecular Weight Species | USP ⟨129⟩, ICH Q6B | ≤1.0% | 0.01% | Pass |
| Residual Solvents | ICH Q3C | Below Class Limits | Below Limits | Pass |
| Bacterial Endotoxin | USP ⟨85⟩ | ≤5 EU/mg (API Spec) | Conforms | Pass |