Catalog Number - 58045-PES25-C

The 58045-PES25-C AQ™ Syringe Filters are pharmaceutical-grade, high-performance membrane filters engineered for HPLC sample preparation, sterile filtration, and dissolution testing in regulated laboratory environments. Featuring a 0.45 µm Polyethersulfone (PES) membrane, these filters provide exceptional throughput, ultra-low protein binding, and extractable-free performance, ensuring maximum analyte recovery and reproducible analytical results.

PES membranes are particularly suited for protein solutions, buffers, and culture media, offering minimal adsorption and excellent flow rates, making them ideal for biological and biopharmaceutical applications where sample recovery is critical—even at low volumes.

✅ 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 (critical for protein recovery)

• ✅ Eliminates a common source of failed methods and investigations

👉 This provides a critical operational and compliance advantage for QC/QA laboratories, especially in biopharma and protein-based 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 analytical and biological workflows.

PES membrane chemistry provides ultra-low protein binding and low extractables, along with excellent throughput and low hold-up volume, ensuring maximum recovery of proteins and sensitive analytes.

These filters offer absolute retention performance and high particulate loading capacity, making them suitable for both clean and moderately complex sample matrices.

The 25 mm diameter supports higher sample volumes and high-throughput workflows, while the white housing with black lettering allows clear identification of 0.45 µm PES filters.

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

Key Features

0.45 µm PES Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High flow and throughput

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

Ultra-Low Protein Binding

• Maximizes recovery of proteins and biomolecules

• Ideal for biological samples

High Throughput Performance

• Fast filtration with low resistance

• Supports high-volume workflows

Low Extractables

• Ensures clean chromatographic baselines

• Improves reproducibility

Absolute Retention

• Reliable filtration performance

• Suitable for critical analytical methods

Regulatory Compliance

• Meets FDA CFR 21 (211.92) requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

25 mm Diameter for High Throughput

• Handles larger sample volumes

• Improves lab productivity

Autoclavable & EO Sterilizable

• 121°C for 30 minutes or Ethylene Oxide

Color-Coded (White / Black)

• Identifies 0.45 µm PES filters

Typical Applications

• HPLC & UHPLC Sample Preparation – clarification prior to injection

• Protein & Biomolecule Filtration – low binding applications

• Cell Culture Media & Buffers – sterile and clean filtration

• Dissolution Testing – pharmaceutical QC workflows

• Biopharmaceutical Analysis – sensitive sample recovery

• Regulated Laboratory Methods – validated, compliant workflows

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PES (Polyethersulfone)

• Pore Size: 0.45 µm

• Diameter: 25 mm

• Housing Material: Polypropylene (PP)

• Color Code: White / 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)

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

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