Description
Manufacturing and Packaging: M4:BaseF™ is precision-manufactured in dedicated lots using aseptic 0.22 µm filtration, then filled and sealed into sterile 100 mL and 500 mL PETG bottles. Every step of production is performed under stringent cGMP guidelines in ISO Class 7 cleanrooms and ISO Class 5 biosafety cabinets to ensure exceptional quality, purity and consistency. We use pre-qualified raw materials and apply rigorous product quality control measures to meet USP standards for pH, osmolality, sterility (bacteria, fungi), mycoplasma, and endotoxin. Each batch is released with a Certificate of Analysis (CoA), with quality details that deliver the high confidence your work demands.
Product Storage: 2°C to 8°C
Product Shelf Life: 18 months post-manufacturing
| Specifications | Acceptance Criteria |
| Visual, Color | Colorless to pale yellow |
| Visual, Clarity | Clear to minor particulates |
| pH (USP <791>) | 6.6 to 7.7 |
| Osmolality (USP<785>) | 280 to 370 mmol/kg |
| Sterility: TSB(USP<71>) | No microbial growth |
| Sterility: FTM (USP<71>) | No microbial growth |
| Mycoplasma (USP<63>) | None detected |
| Endotoxin (USP<85>) | <0.5 EU/mL |
