introduction
Our brand Landnutra supplies n acetylneuraminic acid sigma powder - a high‑purity reference‑grade Neu5Ac produced through microbial fermentation and polished to meet the acceptance criteria routinely associated with Sigma‑Aldrich analytical standards. This lot‑controlled, milligram‑to‑kilogram material is built for analytical laboratories, QC departments, and contract research organisations that need a reliable external standard for HPLC calibration, mass spectrometry identification, or in vitro glycobiology research. Every batch ships with a data‑rich certificate that includes HPLC area‑% purity, chiral purity, residual endotoxin by LAL, residual moisture by Karl Fischer, and a comparative NMR spectrum against a certified reference standard - all pre‑verified so your instrument qualification can proceed without a separate round of in‑house testing. The powder is crystalline, white to off‑white, freely soluble in water, and is packaged under argon in septum‑sealed glass vials or vacuum‑foil drums, depending on order size, to preserve the anhydrous state that analytical labs require.
Specification: ≥99.0% (HPLC, dried basis), Water ≤0.5%, Endotoxin ≤0.1 EU/mg
Sample: Available as 100‑mg septum‑sealed standard vial
Test method: HPLC / NMR / Karl Fischer / LAL / ICP‑MS
Synonyms: N‑Acetylneuraminic acid, Neu5Ac, sialic acid reference standard, NANA standard
MOQ: 100 mg (standard vial) | Bulk package: 1kg vacuum foil bag, 25kg fibre drum
Certificate: ISO 17025 (third‑party), GMP, HACCP, HALAL, Kosher available
Source: Non‑GMO microbial fermentation | CAS: 131-48-6
Product Characteristics
Appearance – white to off‑white crystalline powder; free‑flowing, no visible foreign matter.
Purity Specification – ≥99.0% by HPLC area normalisation; typical lot purity 99.5%; related substances sum <0.8%.
Chiral & Structural Identity – L‑isomer exclusively, confirmed by chiral HPLC and ¹H/¹³C NMR; overlay against a certified reference standard provided in the certificate.
Solubility & Reconstitution – dissolves instantly in water at 100 g/L, giving a clear, colourless solution suitable for mobile phase preparation or cell‑culture media supplementation.
Moisture & Residual Solvent – water content ≤0.3% (Karl Fischer); no detectable methanol, ethanol, or acetone above 10 ppm.
COA
|
Item |
Specification |
Test Result |
|---|---|---|
| Appearance | White crystalline powder | Conforms |
| Assay (HPLC, dried basis) | ≥99.0% | 99.5% |
| Chiral Purity (L‑isomer) | ≥99.9% | 99.95% |
| Water (Karl Fischer) | ≤0.5% | 0.22% |
| Residue on Ignition | ≤0.2% | 0.04% |
| Heavy Metals (as Pb) | ≤10 ppm | <2 ppm |
| Lead (Pb) | ≤1 ppm | <0.3 ppm |
| Total Plate Count | ≤100 cfu/g | <10 cfu/g |
| E. Coli / Salmonella | Negative | Negative |
Benefits of L 5 Methyltetrahydrofolate Powder
01 Ready‑to‑Use Reference Standard – Pre‑weighed, septum‑sealed vials eliminate internal qualification steps, significantly shortening instrument set‑up time for HPLC and MS calibration.
02 Unmatched Lot‑to‑Lot Consistency – A purity CV below 0.4% and chiral purity exceeding 99.9% across batches ensure that long‑term studies are not confounded by reference material drift.
03 Endotoxin‑Controlled for Cell‑Based Assays – With endotoxin levels consistently under 0.05 EU/mg, the powder can be used directly in in vitro glycobiology research without additional purification.
04 Full Spectral Documentation – Each lot includes an NMR overlay against a certified reference standard and a chiral HPLC chromatogram, providing evidence equivalent to primary reference materials.
05 Stability‑Indicating Methods Validated – Forced‑degradation data under acid, alkali, oxidative, and thermal stress help assign relative retention times for degradation products, building robustness into your validated methods.
06 Dual Packaging for Lab & Production – Choose septum‑vial packaging for direct instrument use or vacuum‑foil drums for manufacturing‑scale applications, both maintaining a low‑moisture, low‑oxygen environment.
Application Fields
Reference Material for QC Laboratories – Used for system suitability testing, assay validation, and inter‑laboratory proficiency programmes in nutraceutical and pharmaceutical QC.
Glycobiology & In Vitro Research – Supplements cell‑culture media for studies on sialylation, lectin binding, and pathogen‑host interactions.
Pharmaceutical Excipient Characterisation – Provides a reference substance for identifying and assessing the purity of sialic acid‑based excipients in drug formulations.
Production Process
Non-GMO fermentation produces Neu5Ac, purified, crystallized, dried and packed under strict cGMP & ISO 22000 standards.
Product Quality Advantages
≥99.0% HPLC purity with full chiral and NMR characterisation - comparable to official reference standards.
Endotoxin <0.05 EU/mg, suitable for cell‑based assays and parenteral research.
Residual solvents below 10 ppm, exceeding USP <467> requirements.
Septum‑sealed argon‑purged packaging preserves anhydrous state and prevents oxidative degradation.
Real‑time stability data covering 36 months at 2–8°C and 12 months at 25°C.
Batch‑specific comparative NMR spectrum included - no additional third‑party authentication required.
Export Certificates
We hold and can provide all necessary documentation for international markets:
Non-GMO Certificate / Statement
HACCP Certificate
ISO 22000 Food Safety Management System Certificate
FDA Facility Registration
Halal & Kosher Certificates (upon request)
Comprehensive Third-Party Laboratory Test Reports (SGS, Eurofins, etc.)
Why choose us
Our brand Landnutra also offers customised packaging and analytical support for n acetylneuraminic acid sigma powder:
Custom Vial Formats: pre‑weighed aliquots (10 mg, 50 mg, 100 mg) in amber or clear septum vials with batch‑specific labels.
Bulk & Semi‑Bulk: 1‑kg vacuum foil bags and 25‑kg fibre drums for manufacturing‑scale users.
Blended Reference Kits: combined standards containing Neu5Ac, Neu5Gc, and other sialic acid derivatives for multi‑analyte method development.
Documentation Packages: extended COA, SDS, GMP certificate, stability report, and NMR spectra for regulatory submissions.
For a quotation or to request a 100‑mg standard vial for evaluation, contact Email: wangjing@landnutra.com or WhatsApp: +86 18092657549 - we respond within one business day with full technical documentation.
FAQ
Q1: What makes this a "sigma powder" rather than a standard bulk material?
A: It is manufactured and tested to the level of a Sigma‑Aldrich analytical standard: ≥99% purity, chiral purity confirmed by HPLC and NMR, endotoxin ≤0.05 EU/mg, and it is packaged under argon in septum‑sealed vials for direct use as a reference standard.
Q2: Can I use this powder directly for HPLC calibration without further purification?
A: Yes. Each vial is pre‑weighed and pre‑characterised, and the COA provides an HPLC purity value that can be entered into your calibration method without the need for additional drying or assay.
Q3: Is the product suitable for cell‑culture or in vitro glycobiology experiments?
A: Absolutely. With endotoxin levels routinely below 0.05 EU/mg and a high‑purity profile, the powder is widely used as a media supplement for sialylation studies and lectin‑binding assays.
Q4: How long is the shelf life, and what are the recommended storage conditions?
A: Real‑time stability data support 36 months at 2–8°C in the sealed original packaging. For short‑term use, the powder is stable for 12 months at room temperature in a vacuum‑sealed container.
Q5: What documentation do you provide for regulatory or accreditation audits?
A: We provide a batch‑specific COA, NMR spectral overlay against a certified reference standard, chiral HPLC trace, stability summary, and independent third‑party test reports for heavy metals, endotoxins, and residual solvents.
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