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Maltose (low endotoxin)

Maltose (Maltose), whose scientific name is 4-O-α-D-glucopyranosyl-β-glucopyranose, has a relative average molecular mass of 360.31, is a disaccharide composed of two glucose molecules through α-1,4 glycosidic bonds. Generally contains a crystal water, there are also anhydrous. Its appearance is white crystal or crystalline powder. It is reductive. Maltose has a high solubility in water and is slightly hygroscopic under high humidity conditions.

Classification:

Pharmaceutical excipients for biologics

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Maltose (low endotoxin)

Detailed introduction

1. Product Description

Product Name	English Name	CAS No.	Item No.	Packing specification	Executive standard	CDE Registration Number	FDA Registration Number
Maltose (low endotoxin)	Maltose (Low Endotoxin)	69-79-4	F401-001000	1kg/bottle	CP/USP/EP/JP	F20210000347	——
Maltose (low endotoxin)	Maltose (Low Endotoxin)	69-79-4	F401-010000	10kg/barrel	CP/USP/EP/JP	F20210000347	——
Maltose (low endotoxin)	Maltose (Low Endotoxin)	69-79-4	F401-025000	25kg/barrel	CP/USP/EP/JP	F20210000347	——

2. Product advantages

Meet the requirements of different regulations and market standards: CP/USP/EP/JP;

Higher purity and lower impurities: strict control of organic impurities and inorganic impurities residues in products, strict control of inorganic impurities through the control of chloride, sulfate and ignition residue, and comprehensive control of organic impurities through the control of solvent residues, related substances, dextrin, soluble starch and sulfite and enzyme residues;

Customized packaging: different sizes of packaging can be used according to customer needs;

Higher safety: low endotoxin sugar strictly control microorganisms and endotoxin, using ultrafiltration, recrystallization and other processes to effectively remove bacterial endotoxin.

Product Name

English Name

endotoxin

Aerobic bacteria (TAMC)

Mold and Yeast (TYMC)

Escherichia coli

Maltose (low endotoxin)

Maltose (Low Endotoxin)

<0.5EU/g

<2.0EU/g

<100cfu/g

<10cfu/g

None

3. Product Application

freeze-drying protective agentMaltose can be used as an excipient for freeze-dried powder injection or as a freeze-dried protectant for liposomes and proteins.

blood product stabilizerIt is an extremely common stabilizer in biological products such as immunoglobulins and monoclonal antibodies. It can play a stable protein, prevent protein denaturation precipitation and so on. In addition, maltose can also regulate osmotic pressure and provide calories twice as efficiently as glucose in the infusion. And maltose is metabolized in the body, requires only a slight amount of insulin, and has little effect on blood sugar levels, which makes it an ideal source of energy for diabetics.

4. Characteristic R & D service

1. National Pharmacopoeia Detection Operation Decomposition Guidance

2. Customized specialty preparation services

Key words:

maltose

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