Catalog Number - 58045-PH25-K

The 58045-PH25-K AQ™ Syringe Filters are pharmaceutical-grade, high-throughput 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, reliable chromatographic results in high-volume workflows.

Unlike standard PTFE, H‑PTFE membranes are inherently hydrophilic, allowing seamless compatibility with both aqueous and organic solvents without pre-wetting, making them an ideal all-purpose membrane for mixed solvent systems and method flexibility.

✅ 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 costly investigations

👉 This delivers a major operational and compliance advantage for QC/QA laboratories, especially in high-throughput, regulated workflows involving variable solvent systems.

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 applications.

Hydrophilic PTFE (H‑PTFE) membrane technology combines:

• The chemical resistance of PTFE

• With true aqueous compatibility

This results in universal solvent compatibility without conditioning, eliminating the need for pre-wetting and simplifying workflows.

These filters are designed to be extractable-free from the first 2 mL, ensuring maximum sample integrity, improved reproducibility, and reduced method variability.

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

The 25 mm format supports larger sample volumes, while the bulk 1000/case packaging is ideal for high-throughput QC, analytical, and production environments.

The white housing with blue lettering provides easy identification of 0.45 µm H‑PTFE filters, and each case includes a Certificate of Analysis for full compliance and traceability.

Key Features

0.45 µm Hydrophilic PTFE Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• Combines chemical resistance with aqueous compatibility

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

Universal Solvent Compatibility

• Suitable for 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 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

Bulk Packaging (1000/Case)

• Reduces cost per analysis

• Ideal for high-throughput laboratories

Typical Applications

• HPLC & UHPLC Sample Preparation – mixed solvent filtration

• Aqueous & Organic Filtration – universal compatibility

• Pharmaceutical Analysis – dissolution and QC workflows

• Method Development – flexible solvent systems

• Environmental & Chemical Testing – broad sample compatibility

• High-Throughput Labs – efficient and reproducible performance

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: 1000/Case

• Brand: AQ™

Resources & Ordering Options

• Order hydrophilic PTFE syringe filters, 0.45 µm, 25 mm – 100/pack quantity

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