Cyclolab Gamma-cyclodextrin

Identification & Functionality

Chemical Family: Cyclodextrins
Chemical Name: Gamma Cyclodextrin
Pharma & Nutraceuticals Functions: Solubilizer,
Stabilizer
CAS No.: 17465-86-0
EC No.: 241-482-4
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Solvents & Solubilizers

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Parenteral
Dosage Form: Injectables

Properties

	Value	Units	Test Method / Conditions
Solubility DMSO (100 cm³ solvent, 25°C)	min. 20	g	—
Solubility Methanol (100 cm³ solvent, 25°C)	max. 1.0	g	—
Solubility Water (100 cm³ solvent, 25°C)	min. 20	g	—
Molecular Formula	C(48)H(80)O(40)	—	—
Sulphated Ash Content	max. 0.1	%	EP 2.4.14
Loss on Drying	max. 11.0	%	EP 2.2.32
Formula Weight	1297.2	—	—
Identification A - Specific Optical Rotation	174° - 180°	—	EP 2.2.7
Identification B	Complies with Reference	—	IR EP 2.2.24
pH	5.0-8.0	—	EP 2.2.3
Reducing Sugars	max. 0.2	%	EP Monograph
Light Absorbing Impurities (A230 - A350)	max. 0.10	—	UV-Vis (EP 2.2.25)
Light Absorbing Impurities (A350 - A750)	max. 0.05	—	UV-Vis (EP 2.2.25)
Related Substances	max. 0.5	%	HPLC EP 2.2.29
Residual - ACD	max. 0.5	%	HPLC EP 2.2.30
Residual - BCD	max. 0.5	%	HPLC EP 2.2.31
Cadmium Elemental Impurties	max. 0.2	ppm	EP 2.4.20
Lead Elemental Impurties	max. 0.5	ppm	EP 2.4.21
Arsenic Elemental Impurties	max. 1.5	ppm	EP 2.4.22
Mercury Elemental Impurties	max. 0.3	ppm	EP 2.4.23
Cobalt Elemental Impurties	max. 0.5	ppm	EP 2.4.24
Vanadium Elemental Impurties	max. 1	ppm	EP 2.4.25
Nickel Elemental Impurties	max. 2	ppm	EP 2.4.26
GCD Content	97.0 - 102.0	%	HPLC EP 2.2.29
Identificion A - Specific Optical Rotion	174 - 180	°C	EP 2.2.7

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
United States Pharmacopeia (USP)
Grade: Pharma Grade

Technical Details & Test Data

Storage & Handling

Knowde Enhanced TDS