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PHR1769

Isomalt

Name: Isomalt
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Isomalt, 6-O-α-D-Glucopyranosyl-D-glucitol mixed with 1-O-α-D-glucopyranosyl-D-mannitol

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About This Item

Empirical Formula (Hill Notation):

C₁₂H₂₄O₁₁

CAS Number:

64519-82-0

Molecular Weight:

344.31

UNSPSC Code:

41116107

NACRES:

NA.24

eCl@ss:

25140904

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Properties

Quality Segment

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. I0465000, traceable to USP 1349626

API family

isomalt

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)
pharmaceutical
pharmaceutical

format

neat

storage temp.

2-8°C

SMILES string

O1[C@@H]([C@@H]([C@H]([C@@H]([C@H]1CO)O)O)O)OC[C@@H](O)[C@@H](O)[C@H](O)C(O)CO

InChI

1S/C12H24O11/c13-1-4(15)7(17)8(18)5(16)3-22-12-11(21)10(20)9(19)6(2-14)23-12/h4-21H,1-3H2/t4?,5-,6-,7-,8-,9-,10+,11-,12+/m1/s1

InChI key

SERLAGPUMNYUCK-BLEZHGCXSA-N

Description

General description

Isomalt is a disaccharide alcohol that is commonly used as an excipient in pharmaceutical formulations because of its beneficial characteristics such as the taste, mouth feel, low calorie content, acariogenicity, suitability to diabetics, high stability and low hygroscopicity.
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.

Application

Isomalt may be co-extruded with paracetamol or hydrochlorothiazide in order to improve the tabletting properties and subsequently, the determination of the analyte in pharmaceutical formulations may be carried out using high-performance liquid chromatography (HPLC). It may also be used as an excipient for meloxicam active pharmaceutical ingredient (API) and the determination of the analyte in pharmaceutical formulations can be carried out using near infra-red (NIR) chemometric method.

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.

Analysis Note

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

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 LRAC0143 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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Storage Class

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)