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BioHale® Sucrose

High purity, low endotoxin

Biopharma

Product information

With BioHale® Sucrose we offer the highest purity excipient for the stabilization of biologics to be used in biopharmaceutical formulation. BioHale® Sucrose is a non-reducing crystalline disaccharide made up of one glucose and one fructose molecule joined via a glycosidic linkage.

Commonly used in the pharmaceutical industry as a stabilizer, Sucrose can be also widely used as a cryopreservative and media supplement in a variety of cell-based bioprocesses.

Additionally, BioHale® Sucrose is preferred in applications where solubility or viscosity issues are of supreme importance. BioHale® Sucrose is well suited to provide solution-state stabilization, as well as cryo- and lyo-protection for therapeutic proteins as excipients in the formulations. Sucrose can generally be considered as suitable in most cases, unless constrained by a low-pH formulation.

BioHale® Sucrose can be used in various administration forms, such as for parenteral, oral or ophthalmic route. Beyond our excipient portfolio, customers benefit from our technical solutions and regulatory support to unlock their competitive advantage. Our BioHale® excipients comply with the global regulatory requirements of the pharmaceutical industry (Ph. Eur., USP-NF, JP, ChP) and hold a Chinese Drug Master File (cDMF).

With BioHale® Sucrose, we are currently supporting COVID-19 vaccine production around the world. Read more: DFE Pharma Proudly Supports COVID-19 Vaccination Supply in Pakistan

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If you would like to meet our Biopharma expert, please click here.

Excipient functionality: Stabilizer
Recommended process: Lyophilization
Dosage forms: Parenteral

Typical product data

Source

Source: Plant, isolated from sugar beet

CAS number

CAS number: 57-50-1

Compliance with monographs

Compliance with monographs: Ph. Eur., USP-NF, JP, ChP

Endotoxin level (EU/g)

Endotoxin level (EU/g): ≤ 0.25

Tg (°C)

Tg (°C): ~61

Documentation

Brochure Biohale® View
Product page Biohale Sucrose View
Absence of Melamine Pharmacel, SuperStarch, Disintegrants
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Absence Statement Flavors, Coloring, Sweeteners, Preservatives and Glycols
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BSE statement BioHale (Sucrose, Trehalose)
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Collective statement Sucrose (allergens, latex etc)
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Compliance packaging
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Contaminants Sucrose
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COS Sucrose
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Country of origin Sucrose
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FDA UNI numbers
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Genotoxic impurities statement
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GMO statement Sucrose
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ICHQ3D elemental impurities
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Ingredient declaration Sucrose
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IPEC questionnaire on Nitrosamines
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Nano materials
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No US DMF requirement
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No use of PFC, DEHP, DINP and BPA
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None dangerous substance
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Stability statement BioHale Sucrose
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Residual Solvents Statement BioHale Sucrose
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Safety Information Sucrose
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