Catalog Number - 58045-PES13-A

The 58045-PES13-A AQ™ Syringe Filters are pharmaceutical-grade, high-performance membrane filters designed for HPLC sample preparation 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 reliable and reproducible analytical results.

The 13 mm format is optimized for low sample volume applications, making these filters ideal for biological samples, buffers, and protein solutions where sample conservation and recovery are 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 (especially critical for low-volume workflows)

• ✅ Eliminates a common source of failed methods and investigations

👉 This provides a strong operational and compliance advantage for QC/QA and biopharma laboratories, where sample recovery, reproducibility, and efficiency are essential.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, offering high flow rates and reduced clogging for routine analytical and biological workflows.

PES membrane chemistry provides ultra-low protein binding and low extractables, ensuring maximum recovery of proteins and biomolecules, even in small volumes.

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

The white housing with black lettering allows quick identification of 0.45 µm PES filters, and each pack includes a Certificate of Analysis for full traceability and compliance.

Key Features

0.45 µm PES Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High flow rates 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

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

• Supports routine analytical work

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 (White / Black)

• Identifies 0.45 µm PES filters

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

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: 50/PK

• Brand: AQ™

Resources & Ordering Options

• Purchase PES syringe filters, 0.45 µm, 13 mm – 100/pack quantity

• Order PES syringe filters, 0.45 µm, 13 mm – 1000/case quantity