Description

Potassium Lactobionate is a high-purity, water-soluble salt derived from lactobionic acid, valued for its excellent chelating and stabilizing properties. Its primary commercial significance lies in its role as a critical excipient in the formulation of lyophilized (freeze-dried) injectable pharmaceuticals, where it serves as a superior bulking agent and stabilizer. This makes it essential for manufacturers in the pharmaceutical, biotechnology, and diagnostic reagent industries seeking to enhance the shelf-life and reconstitution properties of sensitive biologics and vaccines.

Application

• Pharmaceutical Lyophilization (Freeze-Drying): A key bulking agent and stabilizer in the formulation of injectable drugs, vaccines, and diagnostic kits to protect active ingredients during the freeze-drying process and upon reconstitution.
• Biologic Stabilizer: Used to stabilize proteins, peptides, antibodies, and other large biomolecules in solution and solid-state formulations, preventing aggregation and denaturation.
• Cryoprotectant: Protects cellular structures and labile compounds from damage caused by freezing and thawing cycles in biopreservation.
• Chelating Agent: Binds to metal ions (e.g., calcium, iron) in cosmetic and topical formulations to improve stability and prevent catalytic degradation.
• Humectant & Moisturizer: Incorporated into high-end cosmetic and skincare products for its ability to attract and retain moisture, improving skin hydration.
• Food Additive: Potential use as a mineral supplement, acidity regulator, or stabilizer in specialized food products, subject to regional regulatory approval (e.g., FCC grade).
• Research & Development: Serves as a standard or reagent in biochemical research, analytical chemistry, and process development for parenteral formulations.

Basic Information

Item	Detail
Product Name	Potassium Lactobionate
CAS No.	69313-67-3
Molecular Formula	C12H21KO12
Molecular Weight	388.39 g/mol
Synonyms	Lactobionic Acid Potassium Salt; Potassium D-lactobionate; 4-O-β-D-Galactopyranosyl-D-gluconic Acid Potassium Salt; D-Lactobionic Acid Monopotassium Salt; Monopotassium Lactobionate; Galactogluconic Acid Potassium Salt
EINECS	Contact for details

Quality Control

Our Potassium Lactobionate is manufactured under strict quality management systems. We offer grades suitable for demanding applications, including potential compliance with USP-NF and Pharmaceutical standards. Every batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing assay, impurities, residual solvents, and microbiological data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent caking and degradation. Recommended long-term storage at controlled room temperature (15-25°C).

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Assay (HPLC)	≥ 98.0%
pH (5% Solution)	6.0 - 8.0
Loss on Drying	≤ 2.0%
Residue on Ignition (Sulfated Ash)	Conforms
Heavy Metals (as Pb)	≤ 10 ppm
Microbiological Enumeration	Meets specified limits
Bacterial Endotoxins	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.