Syringe Filters, 4mm, PES, 0.45um Pore Size. Black Polypropylene, AQ Brand. 100/PK.

Additional Info:

The 58045-PES04-C AQ™ Syringe Filters are pharmaceutical-grade, ultra-low 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 micro-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 investigations

👉 This delivers a critical operational advantage for QC/QA and biopharma laboratories, where every microliter matters and protein recovery is essential.


Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering high flow rates and reduced clogging, even in ultra-small format filters.

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

The 4 mm design minimizes hold-up volume, making these filters ideal for LC‑MS sample preparation, method development, and micro-volume analytical workflows.

The black housing provides quick identification of 0.45 µm PES filters, and each pack includes a Certificate of Analysis for full traceability and regulatory compliance.


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

  • Ideal for analytical 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


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

  • Regulated Laboratory Methods – validated, compliant processes


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: 100/PK

  • Brand: AQ™


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