Pharma Grade Gamma-Cyclodextrin

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Product Detail

Pharmaceutical grade Gamma-cyclodextrin

1. Usage of Pharmaceutical grade Gamma-Cyclodextrin

Gamma-cyclodextrincan be used in pharmaceutical field, ?-cyclodextrin could produce inclusion compound, which could: A. make unstable medicine stable; B. make deliquescing, sticky and liquid medicine more powder-like; C. make insoluble or hard-soluble medicine soluble.

15. Pharma grade Gamma-Cyclodextrin367.png

2. Basic information of Gamma-Cyclodextrin

Product Name : Gammaa-Cyclodextrin

CAS NO. : 17465-86-0

Synonyms : ?-cyclodextrin ; cyclomaltooctaose

Abbreviation : GCD

Grade : Pharmaceutical Grade

Molecular Formula : C₄₈H₈₀O₄₀

Molecular Weight : 1297.12

Molecular structure:

3.Product Specification of Gamma-Cyclodextrin

Specification of Gamma-Cyclodextrin
Test Standard	USP39
ITEMS	SPECIFICATION
Appearance	white powder, insipid, innocent
Assay	98.0%~102.0%
Color and Clarity of solution	10.0%(w/v) water solution is clear
Identification	Consistent with USP Gamma Cyclodextrin RS
Loss on Drying	=11.0%
Specific rotation	+174º~+180º
Reducing substances	=0.5%
Related compounds	=0.5%
Residue on ignition	=0.1%
Heavy Metal	=5ppm
Total viable aerobic count (mould plus yeast)	=1000CFU/g
Escherichia Coli	Absence
Salmonella species	Absence
mould plus yeast	=100CFU/g

4. Feature of Gamma-cyclodextrin

Gamma-cyclodextrin has a larger cavity than b- cyclodextrin, so the cavity can be covered with a wider range of guest molecules; gamma cyclodextrin has a better solubility in water.

Gamma-Cyclodextrin is a ring-shaped molecule made up of eight glucose units linked by alpha-1,4-bonds. The solubility degree of gamma-cyclodextrin in water is 23.2 g/100ml @ 25°C, which is higher than alpha-cyclodextrin and beta-cyclodextrin, and it is used to allow formation of inclusion complexes with bigger molecules.

5. We can supply below documents of Gamma-cyclodextrin

Supply documents of Gamma-cyclodextrin
1	ROS (Synthetic scheme)
2	Process flow diagram
3	List of solvents
4	List of raw material
5	Brief Manufacturing Process
6	Spe&MOA
7	List of potential impurities
8	MSDS
9	Stability Data
10	TSE/BSE
11	RS
12	GMP Agreement
13	Letter of Undertaking
14	Willing to inspection
15	Metal Declaration
16	Melamine Declaration
17	Documents Supporting
18	Manufacturer Declaration
19	3 Batch COAs
20	ISO 9001 Certifications