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Merck
CN

PHR1769

Isomalt

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

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

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经验公式（希尔记法）:
C12H24O11
化学文摘社编号:
64519-82-0
分子量:
344.31
UNSPSC Code:
41116107
NACRES:
NA.24

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产品名称

Isomalt, Pharmaceutical Secondary Standard; Certified Reference Material

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

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)

format

neat

storage temp.

2-8°C

Quality Level

300

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相关类别

Analysis Note

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

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.

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.

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.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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Quantification of meloxicam and excipients on intact tablets by near infrared spectrometry and chemometry
TOMUT? I, et al.
Farmacia, 58(5), 559-571 (2010)
F Ndindayino et al.
International journal of pharmaceutics, 235(1-2), 159-168 (2002-03-07)
Isomalt, a disaccharide alcohol was co-extruded with paracetamol or hydrochlorothiazide (HCT) in order to improve its tabletting properties. After extrusion, isomalt was transformed into an amorphous form, while paracetamol remained crystalline. Hot stage microscopy showed that HCT was amorphous in

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