Catalog Number - 58045-PES13-K

The 58045-PES13-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 Polyethersulfone (PES) membrane, these filters deliver exceptional throughput, ultra-low protein binding, and extractable-free performance, ensuring accurate and reproducible analytical results in high-volume workflows.

The 13 mm format is designed for low sample volume applications, offering efficient filtration with minimal hold-up volume, making it ideal for protein solutions, buffers, and biological samples where recovery is critical.

✅ 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—critical for low-volume workflows

• ✅ Eliminates a common source of failed methods and investigations

👉 This provides a major operational and compliance advantage for QC/QA and biopharma laboratories, especially in regulated, high-throughput environments where sample recovery and repeatability are essential.

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, low extractables, and excellent throughput, ensuring maximum recovery of proteins and sensitive analytes, even in small-volume applications.

The 13 mm design minimizes hold-up volume, maximizing recovery from limited or high-value samples, making it ideal for method development and precision workflows.

The white housing with black lettering allows fast identification of 0.45 µm PES filters, and each case includes a Certificate of Analysis to support full traceability and compliance.

Key Features

0.45 µm PES Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High flow rates and reliable performance

✅ 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 and biopharma samples

Optimized for Low Sample Volumes (13 mm)

• Minimizes hold-up volume

• Ideal for small or high-value samples

High Throughput Performance

• Fast filtration with minimal resistance

• Suitable for high-volume workflows

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 / 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 – small-volume sample clarification

• Protein & Biomolecule Filtration – low binding, high recovery

• Cell Culture Media & Buffers – clean and efficient filtration

• Dissolution Testing – pharmaceutical QC workflows

• Method Development – limited or high-value samples

• Regulated Laboratory Methods – validated, compliant processes

• High-Throughput Labs – consistent and efficient performance

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PES (Polyethersulfone)

• Pore Size: 0.45 µm

• Diameter: 13 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, 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, 13 mm – 100/pack quantity

• Purchase PES syringe filters, 0.45 µm, 13 mm – 50/pack quantity