Catalog Number - 58045-P13-C

The 58045-P13-C AQ™ Syringe Filters are pharmaceutical-grade, high-performance 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.

PTFE membranes are the preferred solution for organic solvent systems, offering superior resistance to aggressive chemicals, including strong solvents, acids, and bases, making them ideal for demanding analytical workflows.

✅ 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 investigations

👉 This delivers a strong operational and compliance advantage for QC/QA laboratories, especially when working with regulated methods and expensive solvents.

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 stable performance in organic solvent systems, 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, offering efficient filtration while minimizing waste, making it well-suited for routine lab applications and limited-volume samples.

The yellow housing enables easy identification of 0.45 µm PTFE filters, and each pack includes a Certificate of Analysis for full traceability and 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

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

• Regulated Laboratory Methods – validated, compliant processes

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: 100/PK

• Brand: AQ™

Resources & Ordering Options

• Order PTFE syringe filters, 0.45 µm, 13 mm – 1000/case quantity

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