Catalog Number - 58045-N13-K

The 58045-N13-K AQ™ Syringe Filters are pharmaceutical-grade, high-throughput 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 chromatographic results in high-volume workflows.

The 13 mm format is optimized for low sample volume applications, offering efficient filtration with minimal sample loss, making it ideal for analytical labs, method development, and 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 200 µL of filtrate

• ✅ Preserves valuable samples—especially critical in small-volume workflows

• ✅ Saves time and reduces risk of failed methods and investigations

👉 This provides a key operational and compliance advantage for QC/QA laboratories, where sample conservation, reproducibility, and audit readiness are essential.

Performance & Design

The 0.45 µm pore size is ideal for sample clarification and prefiltration, delivering high flow rates with reduced clogging, improving efficiency in routine analytical work.

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.

Engineered for smaller sample volumes, the 13 mm design minimizes hold-up volume and waste, ensuring maximum recovery from limited samples.

The green color coding allows immediate identification of 0.45 µm nylon filters, and each case 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 validated analytical methods

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• Eliminates sample waste and variability

Ultra-Low Adsorption

• Suitable for charged and sensitive analytes

• Maximizes analyte recovery

Optimized for Low Sample Volumes (13 mm)

• Minimizes sample loss

• Ideal for analytical and method development workflows

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

Bulk Packaging (1000/Case)

• Reduces cost per analysis

• Ideal for high-throughput QC environments

Typical Applications

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

• Dissolution Testing – pharmaceutical QC workflows

• Method Development – limited and high-value samples

• Regulated Laboratory Methods – validated, compliant processes

• Pharmaceutical Analysis – injectables and formulations

• High-Throughput QC Labs – consistent, efficient performance

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: Nylon‑66

• Pore Size: 0.45 µm

• Diameter: 13 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)

• Sterilization: Autoclave or EO

• Compliance: FDA CFR 21, USP <788>

• Certification: Certificate of Analysis included

• Sterility: Non-sterile

• Pack Size: 1000/Case

• Brand: AQ™

Resources & Ordering Options

• Order Nylon‑66 syringe filters, 0.45 µm, 13 mm – 100/pack quantity

• Purchase Nylon‑66 syringe filters, 0.45 µm, 13 mm – 50/pack quantity