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PHR1439

Beta-Cyclodextrin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

β-Cyclodextrin, Caraway, Cycloheptaamylose, Cyclomaltoheptaose, Schardinger β-Dextrin

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About This Item

Empirical Formula (Hill Notation):
C42H70O35
CAS Number:
7585-39-9
Molecular Weight:
1134.98
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329822602
EC Number:
231-493-2
Beilstein/REAXYS Number:
78623
MDL number:
MFCD00078139

Key Documents

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Product Name

Beta-Cyclodextrin, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

WHGYBXFWUBPSRW-FOUAGVGXSA-N

InChI

1S/C42H70O35/c43-1-8-29-15(50)22(57)36(64-8)72-30-9(2-44)66-38(24(59)17(30)52)74-32-11(4-46)68-40(26(61)19(32)54)76-34-13(6-48)70-42(28(63)21(34)56)77-35-14(7-49)69-41(27(62)20(35)55)75-33-12(5-47)67-39(25(60)18(33)53)73-31-10(3-45)65-37(71-29)23(58)16(31)51/h8-63H,1-7H2/t8-,9-,10-,11-,12-,13-,14-,15-,16-,17-,18-,19-,20-,21-,22-,23-,24-,25-,26-,27-,28-,29-,30-,31-,32-,33-,34-,35-,36-,37-,38-,39-,40-,41-,42-/m1/s1

SMILES string

OC[C@H]1O[C@@H]2O[C@H]3[C@H](O)[C@@H](O)[C@H](O[C@@H]3CO)O[C@H]4[C@H](O)[C@@H](O)[C@H](O[C@@H]4CO)O[C@H]5[C@H](O)[C@@H](O)[C@H](O[C@@H]5CO)O[C@H]6[C@H](O)[C@@H](O)[C@H](O[C@@H]6CO)O[C@H]7[C@H](O)[C@@H](O)[C@H](O[C@@H]7CO)O[C@H]8[C@H](O)[C@@H](O)[C@H](O[C@@H]8CO)O[C@H]1[C@H](O)[C@H]2O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1154569

API family

cyclodextrin

assay

99.9%

form

powder

optical activity

[α]20/D +162±3°, c = 1.5% in H2O

CofA

current certificate can be downloaded

analyte chemical class(es)

oligosaccharides

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

290-300 °C (dec.) (lit.)

application(s)

cleaning products
cosmetics
flavors and fragrances
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Application

Beta-Cyclodextrin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

General description

Beta-Cyclodextrin is the most abundant and cheap cyclic oligosaccharide that forms inclusion complexes with several drug molecules. Its main application is in tablet and capsule formulations.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAA2747 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, 33(4), 5692-5692 (2009)
Gamma Cyclodextrin
USP42-NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 33(4), 5692-5692 (2018)
Nuclear magnetic resonance methods for high molecular weight proteins: a study involving a complex of maltose binding protein and beta-cyclodextrin.
L E Kay
Methods in enzymology, 339, 174-203 (2001-07-21)
H Chen et al.
Se pu = Chinese journal of chromatography, 17(6), 533-538 (2003-01-30)
A review of beta-cyclodextrin bonded stationary phases in chiral liquid chromatography is given, focusing on design and synthesis of beta-cyclodextrin bonded chiral stationary phases. Fifty-three references are presented in this paper.
Omair Aleem et al.
Journal of pharmaceutical and biomedical analysis, 47(3), 535-540 (2008-03-28)
The solid-state properties, dissolution profile and antimicrobial activity of inclusion complexes of cefdinir (CEF) with beta-cyclodextrin (betaCD) and hydroxypropyl beta-cyclodextrin (HPbetaCD) were investigated. The phase solubility profiles of cefdinir with betaCD and HPbetaCD were classified as A(L)-type, which indicates the
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