Catalog Number - 58045-N04-C

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

The 4 mm format is specifically designed for micro-volume filtration, minimizing hold-up volume and maximizing recovery from small 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 analytical results and reproducibility in QC/QA environments.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering fast flow with minimal resistance, even in compact formats.

Nylon‑66 membrane chemistry ensures broad compatibility with aqueous and organic HPLC solvents, while maintaining ultra-low adsorption—even for charged analytes, supporting accurate quantitation.

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

The green color coding allows quick identification of 0.45 µm nylon filters, and each pack includes a Certificate of Analysis for full traceability and 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: 100/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 – 50/pack quantity