Catalog Number - 58045-NDX-100

The 58045-NDX-100 AQ™ Syringe Filters are pharmaceutical-grade, high-capacity membrane filters engineered for HPLC sample preparation and dissolution testing in regulated laboratory environments, particularly for samples with high particulate content. These filters incorporate a three-layer, binder-free borosilicate micro glass fiber prefilter system, followed by a 0.45 µm Nylon‑66 final membrane, delivering exceptional throughput, reduced clogging, and extractable-free performance.

This multi-depth filtration design significantly increases contaminant holding capacity, making these filters ideal for difficult, viscous, or particulate-heavy samples requiring consistent and reliable results.

✅ 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 major operational and compliance advantage for QC/QA laboratories, especially when working with complex or particulate-rich samples where reliability and reproducibility are critical.

Performance & Design

The three-layer glass fiber prefilter system removes larger particles before reaching the final membrane, preventing premature clogging and ensuring consistent flow and extended filter life.

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

The advanced 16-channel outlet design minimizes back pressure, allowing smooth filtration with reduced hand force, improving ergonomics in high-throughput environments.

The 25 mm format is ideal for larger sample volumes and high-throughput workflows, while the black housing with grey lettering allows quick identification of multi-depth 0.45 µm nylon filters.

Each package includes a Certificate of Analysis, ensuring full regulatory traceability and compliance.

Key Features

Multi‑Depth Prefilter System (3 Layers)

• Binder-free borosilicate glass fiber

• Handles high particulate load

• Prevents clogging and extends filter life

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-heavy samples

• Improves workflow efficiency

Ultra-Low Adsorption

• Suitable for sensitive and charged analytes

• Maximizes 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 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 – high particulate sample clarification

• Biological & Complex Samples – multi-stage filtration required

• Dissolution Testing – pharmaceutical QC workflows

• Environmental & Food Testing – particulate-rich matrices

• Regulated Laboratory Methods – validated and compliant processes

• High-Throughput Labs – reduced clogging and improved productivity

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: 100/PK

• Brand: AQ™

Resources & Ordering Options

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

• Purchase multi-depth nylon syringe filters, 0.45 µm, 25 mm – 50/pack quantity