Merck

PHR1769

Supelco

Isomalt

Pharmaceutical Secondary Standard; Certified Reference Material

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别名:
Isomalt, 6-O-α-D-Glucopyranosyl-D-glucitol mixed with 1-O-α-D-glucopyranosyl-D-mannitol
经验公式(希尔记法):
C12H24O11
CAS号:
分子量:
344.31
NACRES:
NA.24

等级

certified reference material
pharmaceutical secondary standard

质量水平

Agency

traceable to Ph. Eur. I0465000
traceable to USP 1349626

API类

isomalt

CofA

current certificate can be downloaded

包装

pkg of 1 g

技术

HPLC: suitable
gas chromatography (GC): suitable

应用

pharmaceutical (small molecule)

格式

neat

储存温度

2-8°C

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

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technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

format

neat

format

neat

format

neat

format

neat

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

storage temp.

2-8°C

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

2-30°C

一般描述

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.

应用

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.

分析说明

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

其他说明

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.

附注

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.

相关产品

产品编号
说明
价格

储存分类代码

11 - Combustible Solids

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


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T1503
货号
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包装规格/数量

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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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