Maltose PH (IVD)

Pharma-grade disaccharide for injectable drugs and diagnostic stabilization.
Ensures solubility, protection, and consistency in infusions, freeze-dried agents, and protein formulations.

High-Purity Maltose for Injectable Drug Formulation and IVD Applications

Maltose PH is a high-purity, non-reducing disaccharide produced by Nagase Viita, a trusted NAGASE Group company specializing in functional carbohydrates. It serves as an excipient and stabilizer in pharmaceutical infusions, injectable anti-cancer drugs, and in vitro diagnostic reagents.

Its excellent solubility, low reactivity, and biocompatibility make it ideal for formulations requiring cryoprotection, osmotic balance, or prevention of aggregation – particularly in freeze-dried or injectable protein-based products like monoclonal antibodies or immunoglobulins.

NAGASE supplies Maltose PH globally for pharmaceutical and diagnostic applications – with regulatory documentation and formulation support available on request.

Applications

Maltose PH is used in injectable drug formulation and diagnostic preservation where solubility and protein stability are critical.

  • Infusion fluids – Active sugar for parenteral nutrition or intravenous osmotic control
  • Freeze-dried injectables – Stabilizes anti-cancer drugs and biologics during lyophilization
  • Immunoglobulin stabilization – Prevents aggregation and denaturation during formulation
  • Diagnostic reagent kits – Preserves proteins and enzymes in lyophilized assays
  • Cryopreservation systems – Enhances viability and structural integrity of biomolecules

Features

Maltose PH offers exceptional purity, biocompatibility, and functional stability for injectable and diagnostic use.

  • High purity (>99%) – Low endotoxin and impurity levels for parenteral applications
  • Excellent solubility – Easily dissolves in aqueous injection solutions or buffers
  • Non-reducing disaccharide – Minimizes Maillard reactions and protein modification
  • Protein and mAb stabilizer – Ideal for immunoglobulin and biologic drug preservation
  • GMP-grade production – Consistent, validated manufacturing for pharmaceutical integration

Additional Information

Purity: Not less than 98 % (low endotoxin)
Regulatory Approval: JP, CP
Others: US type II DMF, Kosher Halal

Packaging Size

  • 25 kg PE bag (carton box)

Frequently Asked Questions about Maltose PH (IVD)

What is Maltose PH used for?
It is used in injectable pharmaceutical formulations, freeze-dried anti-cancer drugs, immunoglobulin stabilization, and IVD reagent preservation.

Can Maltose PH be injected intravenously?
Yes. It is a high-purity, non-reducing disaccharide widely used as a carbohydrate source or stabilizer in infusion fluids and injectable drugs.

How does it help stabilize proteins?
Maltose prevents protein denaturation, aggregation, and loss of bioactivity during freeze-drying, storage, or injection.

Is it compatible with monoclonal antibodies?
Absolutely. It’s commonly used in formulations containing mAbs or plasma proteins to enhance stability and extend shelf life.

Is documentation available for pharma applications?
Yes. NAGASE provides full CoA, impurity profiles, and technical support for regulatory submissions or GMP use.

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In Vitro Diagnostics

Volker Wagner
Sales Manager