Catalog Number - 58045-P13-K

The 58045-P13-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 PTFE (Polytetrafluoroethylene) membrane, these filters provide exceptional chemical resistance, consistent flow performance, and extractable-free filtration, ensuring reliable and reproducible chromatographic results in high-volume workflows.

PTFE membranes are the preferred choice for organic solvent systems, offering superior durability and compatibility with aggressive solvents, acids, and bases, making them ideal for demanding analytical and industrial applications.

✅ Critical Compliance Advantage (No Flush Required)

These filters are validated and certified to meet stringent regulatory requirements, including:

• US FDA CFR Title 21, Part 211.92 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 costly investigations

👉 This provides a major operational and compliance advantage for QC/QA laboratories, particularly in regulated, high-throughput environments using organic solvent systems.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering high flow rates and reduced clogging for routine analytical workflows.

PTFE membrane chemistry provides maximum chemical compatibility, ensuring reliable performance in organic solvents, strong acids, and alkaline conditions, without degradation.

⚠️ Important: PTFE membranes are hydrophobic and not recommended for 100% aqueous or buffer solutions, making them best suited for organic or mixed solvent workflows.

The 13 mm format is ideal for low to moderate sample volumes, providing efficient filtration while minimizing waste, making it well-suited for routine lab use and sample-limited workflows.

The bulk 1000/case packaging supports high-throughput laboratories and production-scale environments.

The yellow housing allows quick identification of 0.45 µm PTFE filters, and each case includes a Certificate of Analysis for full traceability and regulatory compliance.

Key Features

0.45 µm PTFE Membrane (Pharma Grade)

• Ideal for organic solvent filtration

• High chemical resistance and durability

✅ No Initial Flush Required (Validated)

• Extractable-free from first filtrate

• No 200 µL discard required

Superior Chemical Resistance

• Compatible with solvents, acids, and bases

• Will not degrade under harsh conditions

⚠️ Hydrophobic Membrane

• Not suitable for 100% aqueous solutions

• Designed for organic or mixed-phase applications

Optimized for Moderate Volumes (13 mm)

• Efficient filtration with minimal waste

• Suitable for routine analytical workflows

High Throughput Packaging (1000/Case)

• Ideal for large-scale laboratory use

• Reduces cost per analysis

Low Extractables

• Ensures clean chromatographic baselines

• Improves reproducibility

Regulatory Compliance

• Meets FDA CFR 21 (211.92) requirements

• Complies with USP <788>

• Suitable for Sterile Water for Injection

Color-Coded (Yellow)

• Identifies 0.45 µm PTFE filters

Typical Applications

• HPLC & UHPLC Sample Preparation – organic solvent filtration

• Pharmaceutical Analysis – dissolution and QC workflows

• Organic & Chemical Analysis – aggressive solvent systems

• Environmental Testing – non-aqueous sample filtration

• Routine Laboratory Workflows – moderate sample volumes

• High-Throughput QC Labs – consistent, efficient performance

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PTFE (Polytetrafluoroethylene)

• Pore Size: 0.45 µm

• Diameter: 13 mm

• Housing Material: Polypropylene (PP)

• Color Code: Yellow (0.45 µm PTFE)

• Connection Type: Luer Lock / Slip

• Chemical Compatibility: Organic solvents, acids, bases

• Hydrophilicity: Hydrophobic (not for aqueous solutions)

• Extractables: None detectable (no flush required)

• Sterilization: Autoclave or EO

• Compliance: FDA CFR 21 (211.92), USP <788>

• Certification: Certificate of Analysis included

• Sterility: Non-sterile

• Pack Size: 1000/Case

• Brand: AQ™

Resources & Ordering Options

• Order PTFE syringe filters, 0.45 µm, 13 mm – 100/pack quantity

• Purchase PTFE syringe filters, 0.45 µm, 13 mm – 50/pack quantity