Catalog Number - 58045-PES04-K

The 58045-PES04-K AQ™ Syringe Filters are pharmaceutical-grade, high-throughput micro-volume membrane filters engineered for HPLC sample preparation and dissolution testing in regulated laboratory environments. Featuring a 0.45 µm Polyethersulfone (PES) membrane, these filters deliver exceptional throughput, ultra-low protein binding, and extractable-free performance, ensuring accurate and reproducible analytical results—even with extremely limited sample volumes.

The 4 mm format is specifically designed for ultra-low volume filtration, minimizing hold-up volume and maximizing recovery from high-value protein and biological samples, making these filters ideal for LC‑MS workflows and precision analytical applications.

✅ 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 20 µL of filtrate

• ✅ Preserves extremely valuable micro-volume samples

• ✅ Saves time and reduces risk of failed methods and costly investigations

👉 This provides a critical operational advantage for QC/QA and biopharma laboratories, where every microliter matters and protein recovery is essential, especially in high-throughput environments.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering high flow rates and reduced clogging, even in compact filter formats.

PES membrane chemistry provides ultra-low protein binding, low extractables, and excellent flow characteristics, ensuring maximum recovery of proteins and sensitive biomolecules, even in trace sample volumes.

The 4 mm design minimizes hold-up volume, maximizing recovery from limited or high-value samples, making these filters ideal for LC‑MS sample preparation, method development, and micro-volume analytical workflows.

The black housing allows easy identification of 0.45 µm PES filters, and each case includes a Certificate of Analysis for full traceability, compliance, and audit readiness.

Key Features

0.45 µm PES Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High flow and efficient performance

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 20 µL discard required

Ultra-Low Protein Binding

• Maximizes recovery of proteins and biomolecules

• Ideal for biological and biopharma samples

Ultra-Low Volume Format (4 mm)

• Minimizes hold-up volume

• Maximizes recovery from micro-volume samples

High Throughput Performance

• Fast filtration with minimal resistance

• Suitable for high-volume workflows

Low Extractables

• Ensures clean chromatography

• 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 (Black)

• Identifies 0.45 µm PES filters

Bulk Packaging (1000/Case)

• Reduces cost per analysis

• Ideal for high-throughput QC environments

Typical Applications

• HPLC & UHPLC Sample Preparation – micro-volume sample clarification

• LC‑MS Workflows – maximum recovery with minimal loss

• Protein & Biomolecule Filtration – low binding, high recovery

• Cell Culture Media & Buffers – clean filtration

• Method Development – limited or high-value samples

• Dissolution Testing – pharmaceutical QC workflows

• High-Throughput Laboratories – consistent and efficient performance

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PES (Polyethersulfone)

• Pore Size: 0.45 µm

• Diameter: 4 mm

• Housing Material: Polypropylene (PP)

• Color Code: Black (0.45 µm PES)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Aqueous solutions, buffers, biological samples

• Protein Binding: Ultra-low

• Extractables: None detectable (no flush required)

• Initial Discard Volume: None (20 µL not 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 PES syringe filters, 0.45 µm, 4 mm – 100/pack quantity

• Purchase PES syringe filters, 0.45 µm, 4 mm – 50/pack quantity