KLEPTOSE HPB Biopharma Hydroxypropyl Betadex - Roquette

Identification & Functionality

Chemical Family: Cyclodextrins
Chemical Name: (2-Hydroxypropyl)-β-cyclodextrin
Pharma & Nutraceuticals Functions: Encapsulant,
Stabilizer
CAS No.: 128446-35-5
EC No.: 603-269-8
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Modified & Controlled Release
Chemical Structure

Features & Benefits

Benefit Claims: Enhanced Shelf Life,
High Surface Activity,
Low Endotoxin,
Low Molar Substitution
Labeling Claims: Pyrogen-free

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Parenteral
Dosage Form: Injectables
Manufacturing Technology: Encapsulation
Application: KLEPTOSE® HPB for biopharma uses. It is a low endotoxin pyrogen-free solution for protein stabilization. It exhibits surface activity and anti-aggregation properties for therapeutic proteins shelf life extension. KLEPTOSE® HPB Biopharma also enables to reduce thermal and agitation sensitivity of formulations.

Properties

Physical Form: Powder,
Solid
Appearance: Crystalline powder, White or almost white amorphous
Soluble in: Water, Propylene glycol
Typical Properties
Physico-Chemical Properties
Microbiological Values
Note: (*) - Compliance data - Tests not performed

(**) - Monitoring plan
Solubility: Highly soluble in water. At high concentration, the wetting and dissolution time of the powder is delayed due to its low density and increased viscosity. Soluble in ethanol. Freely soluble in propylen glycol.

	Value	Units	Test Method / Conditions
Any Other Impurity	max. 0.25	%	USP/NF
Bacterial Endotoxins	max. 5	IU/g	—
Conductivity	max. 200	microS/cm	Ph.Eur.-USP/NF
Impurity A: Beta Cyclodextrin	max. 1.5	%	Ph.Eur.-USP/NF
Impurity B: Propane 1,2 Diol	max. 2.5	%	Ph.Eur.-USP/NF
Infrared	Conforms	—	Ph.Eur.-USP/NF
Molar Substitution	0.40 - 1.50	—	Ph.Eur.-USP/NF
Molar Substitution Nominal Value	0.9	—	—
Molecular Weight	1387	g/mol	—
Propylene Oxide	max. 1	mg/kg	USP/NF
Sum of Impurities Other Than A	max. 1.0	%	Ph.Eur.
Total of Other Impurities	max. 1	%	USP/NF
Water Content (LOD)	4	%	—
Water Content (LOD)	max. 10	%	—

	Value	Units	Test Method / Conditions
Loss on Drying	max. 10.0	%	Ph.Eur.-USP/NF

	Value	Units	Test Method / Conditions
Escherichia coli	Not detetced	per 10g	—
Pseudomonas	Not detected	per 10g	—
Salmonella	Not detected	per 10g	—
Total Aerobic Microbial Count	max. 1000	CFU/g	Plate count
Total Yeasts and Moulds Count	max. 100	CFU/g	—

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
GMP,
Japan Pharmacopeia (JP),
United States Pharmacopeia (USP)
Grade: Pharma Grade
Quality Standards: ICH Q7
Conformity: Current pharmacopeias Ph.Eur.(1804) and U.S.P./N.F.

Technical Details & Test Data

Note: Methods used by Roquette may be Ph.Eur. or USP/NF or internal validated methods which have been compared to the pharmacopeia monograph.
Water Sorption Isotherm at 20°C
Glass Transition Temperature vs. Water Content
Viscosity in Water
Surface Tension in Water
Osmolality
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Packaging & Availability

Packaging Type: Drums
Packaging Information: ROQ Product Code: 346113
Article (SKU) Code: 346113105E
Package Size & Type: 1 kg HDPE bottle

Storage & Handling

Storage & Shelf Life: Store in a dry area, preferably protected from wide humidity and temperature variations.

Retest Data Manufacturing date + 3 years in its original packaging.

KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex Cyclodextrin