Cyclolab (2-Hydroxypropyl)-beta-cyclodextrin (DS~4.5)

Identification & Functionality

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

Properties

Physical Form: Powder,
Solid
Odor: Odorless
Appearance: White or almost white, amorphous or crystalline powder, 1 g dissolved in 2 mL of water with heating is clear and colorless and remains so after cooling
Typical Properties
Microbiological Values

	Value	Units	Test Method / Conditions
Solubility DMF (100 cm³ solvent, 25°C)	min. 33	g	—
Solubility Methanol (100 cm³ solvent, 25°C)	min. 33	g	—
Solubility Water (100 cm³ solvent, 25°C)	min. 33	g	—
Average Molecular Formula	C(42)H(70)-nO(35) · (C3H7O)n	—	—
Cadmium Content	max. 0.2	ppm	EP 2.4.20
Lead Content	max. 0.5	ppm	EP 2.4.21
Arsenic Content	max. 1.5	ppm	EP 2.4.22
Mercury Content	max. 0.3	ppm	EP 2.4.23
Cobalt Content	max. 0.5	ppm	EP 2.4.24
Vanadium Content	max. 1	ppm	EP 2.4.25
Nickel Content	max. 2	ppm	EP 2.4.26
Identification A	Complies with Reference Standard	—	IR (EP 2.2.24)
Conductivity (25 °C, 1% solution in water)	max. 200	µS/cm	EP 2.2.38
Residual - BCD	max. 1.5	%	HPLC (EP 2.2.29)
Propylene Glycol	max. 2.5	%	GC (EP 2.2.28)
Total Other Impurities	max. 1.0	%	HPLC (EP 2.2.29)
Average Degree of Substitution (n)	2.8 - 10.5 (molar substitution: 0.4 - 1.5)	—	NMR (EP 2.2.33)
TYMC	max. 10^2	CFU/g	EP 2.6.12, EP 2.2.14
Salmonella	absent/10g	—	EP 2.6.12, EP 2.2.15
E. Coli	absent/1g	—	EP 2.6.12, EP 2.2.16
Loss on Drying	max. 10.0	%	EP 2.2.32
Escherichia Coli	Absent	1g	EP 2.6.12, EP 2.2.16
Salmonella	Absent	10g	EP 2.6.12, EP 2.2.15

	Value	Units	Test Method / Conditions
TAMC	max. 10^3	CFU/g	EP 2.6.12, EP 2.2.13
Bacterial Endotoxin Test	max.10	IU/g	EP 2.6.14

Regulatory & Compliance

Technical Details & Test Data

Possible Impurities: Propylene glycol

Beta-cyclodextrin

Hydroxypropylated linear dextrins

Storage & Handling

Knowde Enhanced TDS