Catalog Number - 58045-P25-C

The 58045-P25-C AQ™ Syringe Filters are pharmaceutical-grade, high-performance membrane filters engineered for HPLC sample preparation and dissolution testing in regulated laboratory environments. Featuring a 0.45 µm PTFE (Polytetrafluoroethylene) membrane, these filters deliver exceptional chemical resistance, high flow rates, and extractable-free performance, ensuring consistent and reproducible chromatographic results.

PTFE membranes are the preferred choice for organic solvents, offering superior resistance to aggressive chemicals, making them ideal for analytical workflows involving strong solvents, acids, and bases.

✅ Critical Compliance Advantage (No Flush Required)

These filters are validated and certified to meet stringent regulatory requirements, including:

• US FDA CFR Title 21, Part 211.92 for minimum fiber release

• USP <788> for particulate matter in injectables

• USP requirements for “Sterile Water for Injection”

Because of this validated performance:

• ✅ No initial flushing is required

• ✅ No need to discard the first 200 µL of filtrate

• ✅ Preserves valuable samples

• ✅ Eliminates a common source of failed methods and investigations

👉 This delivers a strong operational and compliance advantage for QC/QA laboratories, particularly when working with costly solvents or regulated analytical methods.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering high flow rates with minimal clogging, ideal for routine and high-throughput workflows.

PTFE membrane chemistry offers maximum chemical compatibility, ensuring performance in organic solvent systems, aggressive acids, and alkaline solutions, without degradation.

⚠️ Important: PTFE is hydrophobic and not recommended for 100% aqueous or buffer solutions, making it best suited for organic or mixed solvent applications.

The advanced 16-channel outlet design reduces back pressure, allowing smooth filtration with reduced hand force, improving ergonomics and consistency in high-volume workflows.

The 25 mm format supports higher sample volumes, while the yellow housing enables quick identification of 0.45 µm PTFE filters.

Each pack includes a Certificate of Analysis for full traceability and compliance.

Key Features

0.45 µm PTFE Membrane (Pharma Grade)

• Ideal for organic solvent filtration

• High flow and durability

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

Superior Chemical Resistance

• Compatible with strong solvents, acids, and bases

• Resistant to degradation

⚠️ Hydrophobic Membrane

• Not suitable for 100% aqueous solutions

• Designed for organic or mixed-phase systems

High Throughput Performance (25 mm)

• Handles larger sample volumes

• Ideal for routine lab workflows

Advanced 16-Channel Outlet Design

• Reduces back pressure

• Requires less hand force

Low Extractables

• Clean chromatographic baselines

• Improves reproducibility

Regulatory Compliance

• Meets FDA CFR 21 (211.92) requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

Color-Coded (Yellow)

• Identifies 0.45 µm PTFE filters

Typical Applications

• HPLC & UHPLC Sample Preparation – organic solvent filtration

• Pharmaceutical Analysis – dissolution and QC testing

• Chemical & Organic Analysis – aggressive solvent systems

• Environmental Testing – non-aqueous samples

• Industrial Laboratories – harsh chemical workflows

• Regulated Laboratory Methods – validated, compliant processes

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PTFE (Polytetrafluoroethylene)

• Pore Size: 0.45 µm

• Diameter: 25 mm

• Housing Material: Polypropylene (PP)

• Color Code: Yellow (0.45 µm PTFE)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Organic solvents, acids, bases

• Hydrophilicity: Hydrophobic (not for aqueous solutions)

• Extractables: None detectable (no flush required)

• Sterilization: Autoclave or EO

• Compliance: FDA CFR 21 (211.92), USP <788>

• Certification: Certificate of Analysis included

• Sterility: Non-sterile

• Pack Size: 100/PK

• Brand: AQ™

Resources & Ordering Options

• Order PTFE syringe filters, 0.45 µm, 25 mm – 1000/case quantity

• Purchase PTFE syringe filters, 0.45 µm, 25 mm – 50/pack quantity