N-Acetylneuraminic Acid

N-Acetylneuraminic Acid (Sialic Acid)

Pharmaceutical-Grade Purity | Sustainable Biosynthesis

Cas.No	131-48-6
Assay	98.0-102.0%
Description	White to pale brown crystals or crystalline powder
Uses	Food,Nutritional supplement,Cosmetics
Packaging	25kg

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SRBio N-Acetylneuraminic Acid (Sialic Acid/Neu5Ac)

Product Introduction

N-Acetylneuraminic Acid (Neu5Ac), the predominant form of Sialic Acid, is a 9-carbon monosaccharide critical to glycoprotein and ganglioside structures. As a key mediator of cell-to-cell recognition, immune response modulation, and pathogen defense mechanisms, it is indispensable for:

Advanced Therapeutics: Viral entry inhibitors, oncology drugs, neural repair agents
Clinical Nutrition: Infant brain development, maternal health formulations
Diagnostic Reagents: Cancer biomarkers, infectious disease detection kits
Cosmeceutical Innovations: Glycocalyx repair, bioactive anti-aging compounds

SRBio delivers >99% HPLC-verified Neu5Ac through proprietary non-animal enzymatic synthesis, eliminating contamination risks while ensuring ethical, sustainable production.

SRBio’s Unmatched Quality Specifications

Parameter	Specification	Test Method
Purity	≥99.0% (Standard Grade)	HPLC-ELSD/UV
Custom Purity	≥99.5% (Pharmaceutical Grade)	qNMR
Appearance	White to off-white crystalline powder	Visual
Heavy Metals	≤10 ppm	ICP-MS
Endotoxins	<0.05 EU/mg	LAL Test
Residual Solvents	Meets ICH Q3C Class 2 Limits	GC-FID
Water Content	≤1.0% (Karl Fischer)	KF Coulometry
Specific Rotation	-32° to -36° (c=2 in H₂O)	Polarimetry
Stability	36 months at -20°C in sealed containers	Accelerated Stability Studies

Manufacturing Excellence: The SRBio Advantage

✅ Proprietary Fermentation Platform

Strain Engineering: Genetically optimized E. coli strains with knockout neuraminidase genes prevent product degradation.
High-Yield Bioreactors: 5,000L fed-batch fermentation achieving >15 g/L titers, reducing COGs by 40% vs. competitors.
Animal-Free Process: 100% microbial biosynthesis (Non-GMO Status Documentation available).

✅ Downstream Precision Purification

Tangential Flow Filtration (TFF): Removes proteins >10 kDa
Ion-Exchange Chromatography: Separates anionic impurities
Crystallization: Ethanol-water recrystallization for polymorph control
Lyophilization: Low-temperature drying preserves bioactivity

✅ Beyond Compliance Quality Control

Triple Verification: Identity (FT-IR/NMR), Purity (HPLC-MS), Safety (USP <61>/<62>)
Traceability: Full electronic batch records (EBR) with CAS 131-48-6, Lot-specific CoA
Regulatory Master Files: Active DMF (Drug Master File) for FDA submissions

Competitive Differentiation

Feature	SRBio	Industry Standard
Purity Consistency	±0.2% batch variance	±2-5% variance
Endotoxin Control	<0.05 EU/mg (Validated LAL)	0.1–1.0 EU/mg
Supply Scale	mg to 500 kg/month	Limited to <100 kg
Documentation	EDQM CEP, FDA DMF on file	Basic CoA only
Customization	Salt forms, isotopic labels	Standard grade only

Targeted Applications & Evidence

Vaccine Development: Enhances immunogenicity in conjugate vaccines (e.g., Streptococcus pneumoniae).
Neurology: Crosses BBB to support synaptic plasticity (Published in vivo data available).
Anti-Viral Agents: Blocks influenza hemagglutinin binding (IC₅₀ data in technical dossier).
Infant Nutrition: Clinically validated cognitive benefits (DHA-SA synergy studies).

Partnership Benefits

🔬 Scientific Support Services

Structure confirmation (¹H/¹³C NMR, HRMS)
Impurity profiling (HPLC-ELSD chromatograms)
Cell-based bioactivity assays (Custom protocols)

📦 Supply Chain Reliability

Global Logistics: Cold-chain shipping (-20°C) with real-time monitoring
Inventory Programs: VMI (Vendor-Managed Inventory) for just-in-time delivery
Bulk Discounts: Tiered pricing at 100g, 1kg, 10kg+ quantities