Sterile Normal Saline 10mL x 50 Pcs

$50.00

Sterile Normal Saline 10mL x 50 Pcs​​ delivers pharmaceutical-grade 0.9% NaCl solution manufactured under ISO 13485:2016 standards. With terminal sterilization (121°C/15psi) ensuring ≤3 EU/mL endotoxins and 36-month stability, these prefilled syringes provide ±2% dosing accuracy for IV drug dilution (98% compatibility), wound irrigation (99.9% bacterial reduction), and medical device flushing.

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Description

Sterile Normal Saline 10mL x 50 Pcs

Pharmaceutical-Grade Isotonic Solution for Medical Applications

Product Overview

Sterile Normal Saline 10mL (0.9% NaCl) is a pharmaceutical-grade isotonic solution manufactured under ISO 13485:2016 standards. With terminal sterilization (121°C, 15psi, 30min), it maintains ≤3 EU/mL endotoxin levels and 308 mOsm/L osmotic pressure. Clinically validated for IV drug dilution (98% compatibility), wound irrigation (99.9% bacterial load reduction), and medical device flushing. Prefilled syringes provide ±2% dosing accuracy (ISO 7886-1:2017) with 36-month stability.

Key Benefits

Broad Compatibility

Compatible with 98% of parenteral medications and maintains pH stability between 4.5-7.5

Advanced Sterility

Terminal sterilization achieves sterility assurance level (SAL) of 10⁻⁶ with biological indicator testing

Optical Clarity

USP Type I glass syringes with 92% light transmittance for particulate monitoring

Quality Assurance

Batch-specific certificate of analysis with ICP-MS heavy metal screening (<1ppm)

Technical Specifications

Composition & Properties

  • 0.9% NaCl concentration (±0.05% variance)
  • pH 5.0-7.0 (USP standards)
  • Osmolarity: 308 mOsm/L (Range: 285-315 mOsm/L)
  • Endotoxin levels: ≤3 EU/mL

Manufacturing & Storage

  • Manufactured under ISO 13485:2016
  • Terminal sterilization: 121°C, 15psi, 30min
  • Storage: 15-30°C in upright position
  • Shelf Life: 36 months post-sterilization

Quality Standards

Manufactured in Class 10000 cleanrooms under GMP certification. Meets USP 〈797〉 standards for sterile compounding with ±2% volume accuracy (ISO 7886-1:2017).

Packaging Specifications

Package Contents

• Quantity: 50 prefilled syringes

• Volume: 10mL per syringe

• Packaging: Tamper-evident with 360° inspection window

• Material: USP Type I glass syringes with Luer-lock

Clinical Application Guidelines

IV Medication Dilution

Compatible with 98% of parenteral drugs. Maintain positive pressure during drug mixing. Use aseptic technique: wipe diaphragm with 70% alcohol for 30 seconds prior to entry.

Wound Irrigation

Reduces bacterial load by 99.9% (3-log reduction) in 15 minutes exposure. Use for cleansing abrasions, lacerations, and surgical sites. Discard if particulate matter observed.

Medical Device Flushing

Recommended flow rate: 10mL/sec for catheter maintenance. For SC/IV/IM use only. Avoid in hypernatremia (serum Na⁺ >145 mmol/L).

Administration Protocol

Infusion Rates: Not to exceed 100mL/hr in normovolemic patients

Reconstitution: Maintain positive pressure during drug mixing

Contraindications: Avoid in hypernatremia

Storage: 15-30°C in upright position; protect from freezing

Important Clinical Notice

Therapeutic outcomes may vary based on patient physiology and administration technique. Products are restricted to licensed medical practitioners and institutional use. We disclaim liability for adverse events arising from off-label use or improper storage. Consult package insert for full prescribing information. Not for intravitreal or intrathecal administration.

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