Catalog Number - 58045-NDX-A

The 58045-NDX-A AQ™ Syringe Filters are pharmaceutical-grade, high-capacity membrane filters engineered for HPLC sample preparation and dissolution testing in regulated laboratory environments, especially for samples with high particulate load. These filters feature a multi-depth prefiltration system consisting of three binder-free borosilicate micro glass fiber layers, followed by a 0.45 µm Nylon‑66 final membrane, delivering exceptional throughput, reliability, and extractable-free performance.

This multi-layer design significantly increases dirt-holding capacity, reduces clogging, and extends filtration life, making these filters ideal for challenging or particulate-heavy 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 200 µL of filtrate

• ✅ Preserves valuable samples

• ✅ Eliminates a common source of failed methods and investigations

👉 This provides a critical operational and compliance advantage for QC/QA laboratories, especially when working with complex or particulate-heavy samples that require reliable, reproducible results.

Performance & Design

The three-layer glass fiber prefilter system removes larger particles before reaching the membrane, significantly improving flow consistency and preventing premature clogging.

The 0.45 µm Nylon‑66 final membrane is optimized for sample clarification and prefiltration, delivering high flow rates and low adsorption, even for charged analytes.

The advanced 16-channel outlet design reduces back pressure, enabling smooth filtration with less hand force, improving user ergonomics during repetitive workflows.

The 25 mm diameter supports high sample throughput, making these filters ideal for routine and high-volume laboratory use.

The black housing with grey lettering provides clear visual identification for 0.45 µm multi-depth prefilter nylon filters, and each pack includes a Certificate of Analysis for full regulatory traceability.

Key Features

Multi‑Depth Glass Fiber Pre‑Filters (3 Layers)

• Removes high particulate loads before membrane

• Extends filter life and prevents clogging

0.45 µm Nylon‑66 Final Membrane (Pharma Grade)

• Ideal for clarification and prefiltration

• High consistency and reliability

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

High Throughput Performance

• Designed for difficult or particulate-rich samples

• Improves workflow efficiency

Ultra-Low Adsorption

• Suitable for charged and sensitive analytes

• Maximizes analyte recovery

Advanced 16-Channel Outlet Design

• Reduces back pressure

• Requires less hand force

Regulatory Compliance

• Meets FDA CFR Title 21 requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

25 mm Diameter for High Throughput

• Handles larger sample volumes

• Ideal for routine lab workflows

Autoclavable & EO Sterilizable

• 121°C for 30 minutes or Ethylene Oxide

Color-Coded (Black / Grey)

• Identifies multi-depth 0.45 µm nylon filters

Typical Applications

• HPLC & UHPLC Sample Preparation – particulate-heavy sample clarification

• Biological & Complex Matrices – samples requiring prefiltration

• Dissolution Testing – pharmaceutical QC workflows

• Environmental & Food Samples – high particulate content

• Regulated Laboratory Methods – validated, compliant processes

• High-Throughput Labs – reduced clogging and improved efficiency

Specifications

• Filter Type: Syringe Filter with Multi-Depth Prefilters (Pharma Grade)

• Membrane Material: Nylon‑66

• Prefilter Material: Binder-Free Borosilicate Glass Fiber (3 layers)

• Pore Size (Final Membrane): 0.45 µm

• Diameter: 25 mm

• Housing Material: Polypropylene (PP)

• Color Code: Black / Grey (Multi-depth 0.45 µm Nylon)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Aqueous and organic solvents

• 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 multi-depth nylon syringe filters, 0.45 µm, 25 mm – 100/pack quantity

• Order multi-depth nylon syringe filters, 0.45 µm, 25 mm – 1000/case quantity