Catalog Number - 58045-P04-C

The 58045-P04-C AQ™ Syringe Filters are pharmaceutical-grade, ultra-low volume 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, fast flow rates, and extractable-free filtration, ensuring reliable and reproducible analytical results—even with extremely limited sample volumes.

PTFE membranes are the preferred choice for organic solvent systems, offering superior durability and resistance to aggressive 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 20 µL of filtrate

• ✅ Preserves extremely valuable micro-volume samples

• ✅ Eliminates a common source of failed methods and investigations

👉 This delivers a critical advantage for LC‑MS users and analytical laboratories, where sample conservation and accuracy are essential.

Performance & Design

The 0.45 µm pore size is optimized for sample clarification and prefiltration, delivering high flow rates and reduced clogging, even in ultra-small filter formats.

PTFE membrane chemistry provides maximum chemical compatibility, ensuring stable 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 systems.

The 4 mm format minimizes hold-up volume, maximizing recovery from high-value, limited-volume samples, making these filters ideal for LC‑MS, method development, and precision analytical workflows.

The yellow housing enables quick identification of 0.45 µm PTFE filters, and each pack 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 20 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

Ultra-Low Volume Format (4 mm)

• Minimizes hold-up volume

• Maximizes recovery of micro-volume samples

High Throughput Performance

• Fast filtration with minimal resistance

• Ideal for analytical workflows

Low Extractables

• Clean chromatographic baselines

• Improves reproducibility

Regulatory Compliance

• Meets FDA CFR Title 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 – micro-volume organic solvent filtration

• LC‑MS Workflows – maximum recovery with minimal loss

• Pharmaceutical Analysis – dissolution and QC workflows

• Organic & Chemical Analysis – aggressive solvent systems

• Method Development – limited or high-value samples

• Regulated Laboratory Methods – validated, compliant processes

Specifications

• Filter Type: Syringe Filter (Pharma Grade)

• Membrane Material: PTFE (Polytetrafluoroethylene)

• Pore Size: 0.45 µm

• Diameter: 4 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)

• Initial Discard Volume: None (20 µL not required)

• Sterilization: Autoclave or EO

• Compliance: FDA CFR Title 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, 4 mm – 1000/case quantity

• Purchase PTFE syringe filters, 0.45 µm, 4 mm – 50/pack quantity