Catalog Number - 58045-N04-A

The 58045-N04-A 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 Nylon‑66 membrane, these filters deliver exceptional consistency, ultra-low adsorption, and extractable-free performance, ensuring accurate and reproducible analytical results—even with very small sample volumes.

The 4 mm format is specifically designed for micro-volume filtration, minimizing hold-up volume and maximizing recovery from limited or high-value samples.

✅ 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 is a critical advantage for micro-volume workflows, where even minimal sample loss can significantly impact results and repeatability in QC/QA environments.

Performance & Design

The 0.45 µm pore size is ideal for sample clarification and prefiltration, enabling fast flow with minimal resistance, even in small-format devices.

Nylon‑66 membrane chemistry provides broad compatibility with aqueous and organic HPLC solvents, while maintaining ultra-low adsorption—even for charged analytes, ensuring high analyte recovery.

The 4 mm design minimizes hold-up volume, making it ideal for mass spectrometry sample prep, method development, and limited-volume analytical workflows.

The green color coding enables quick identification of 0.45 µm nylon filters, and each pack includes a Certificate of Analysis for complete traceability and regulatory compliance.

Key Features

0.45 µm Nylon‑66 Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High consistency for critical analytical methods

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 20 µL discard required

Ultra-Low Adsorption

• Suitable for charged and sensitive analytes

• Maximizes analyte recovery

Ultra-Low Volume Format (4 mm)

• Minimizes hold-up volume

• Maximizes recovery from small samples

Regulatory Compliance

• Meets FDA CFR Title 21 requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

Broad Solvent Compatibility

• Compatible with aqueous and organic HPLC solvents

• Ideal for mixed solvent systems

Autoclavable & EO Sterilizable

• 121°C for 30 minutes or Ethylene Oxide

Color-Coded (Green)

• Identifies 0.45 µm nylon filters

Typical Applications

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

• LC-MS Workflows – minimal sample loss required

• Method Development – limited or high-value samples

• Dissolution Testing – pharmaceutical QC workflows

• Regulated Laboratory Methods – validated, compliant processes

• Aqueous & Organic Filtration – mixed solvent compatibility

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: Nylon‑66

• Pore Size: 0.45 µm

• Diameter: 4 mm

• Housing Material: Polypropylene (PP)

• Color Code: Green (0.45 µm Nylon)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Aqueous and organic solvents

• 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: 50/PK

• Brand: AQ™

Resources & Ordering Options

• Order Nylon‑66 syringe filters, 0.45 µm, 4 mm – 1000/case quantity

• Purchase Nylon‑66 syringe filters, 0.45 µm, 4 mm – 100/pack quantity