Catalog Number - 58045-PH25-C

The 58045-PH25-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 Hydrophilic PTFE (H‑PTFE) membrane, these filters deliver exceptional throughput, universal solvent compatibility, and extractable-free performance, ensuring consistent and reproducible analytical results.

Unlike traditional PTFE, H‑PTFE membranes are inherently hydrophilic, enabling seamless use with both aqueous and organic solvents without pre-wetting, making them an ideal universal filtration solution for mixed-phase workflows.

✅ Critical Compliance Advantage (No Flush Required)

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

• US FDA CFR Title 21, Part 210.3(b)(6) 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 provides a major operational and compliance advantage for QC/QA laboratories, especially when working with variable solvent systems in regulated workflows.

Performance & Design

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

Hydrophilic PTFE (H‑PTFE) membrane chemistry combines the chemical resistance of PTFE with aqueous compatibility, enabling true universal use across aqueous, organic, and mixed solvent systems—without conditioning.

These filters are designed to be extractable-free from the first 2 mL of filtration, ensuring maximum sample integrity and reproducibility.

The advanced 16-channel outlet design reduces back pressure, allowing smooth filtration with reduced hand force, improving ergonomics and productivity.

The 25 mm format supports larger sample volumes, while the white housing with blue lettering allows quick identification of 0.45 µm H‑PTFE filters.

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

Key Features

0.45 µm Hydrophilic PTFE Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• Combines solvent resistance with aqueous compatibility

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

Universal Solvent Compatibility

• Works with aqueous and organic solutions

• No pre-wetting required

High Chemical Resistance

• Compatible with solvents, acids, and bases

• Maintains PTFE durability

High Throughput Performance (25 mm)

• Handles larger sample volumes

• Ideal for routine and high-volume workflows

Advanced 16-Channel Outlet Design

• Reduces back pressure

• Requires less hand force

Low Extractables

• Ensures clean chromatographic baselines

• Improves reproducibility

Regulatory Compliance

• Meets FDA CFR Title 21 requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

Autoclavable & EO Sterilizable

• 121°C for 30 minutes or Ethylene Oxide

Color-Coded (White / Blue)

• Identifies 0.45 µm H‑PTFE filters

Typical Applications

• HPLC & UHPLC Sample Preparation – mixed solvent filtration

• Aqueous & Organic Filtration – universal compatibility

• Pharmaceutical Analysis – dissolution and QC workflows

• Method Development – variable solvent systems

• Environmental & Chemical Testing – broad sample compatibility

• Regulated Laboratory Methods – validated, compliant processes

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: Hydrophilic PTFE (H‑PTFE)

• Pore Size: 0.45 µm

• Diameter: 25 mm

• Housing Material: Polypropylene (PP)

• Color Code: White / Blue (0.45 µm H‑PTFE)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Aqueous and organic solvents

• Hydrophilicity: Hydrophilic (no pre-wetting required)

• Extractables: None detectable (no flush required)

• Sterilization: Autoclave or EO

• Compliance: FDA CFR 21, USP <788>

• Certification: Certificate of Analysis included

• Sterility: Non-sterile

• Pack Size: 100/PK

• Brand: AQ™

Resources & Ordering Options

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

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