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Key Documents

PHR1769

Supelco

Isomalt

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

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

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About This Item

Fórmula empírica (notación de Hill):
C12H24O11
Número de CAS:
Peso molecular:
344.31
Código UNSPSC:
41116107
NACRES:
NA.24

grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

Agency

traceable to Ph. Eur. I0465000
traceable to USP 1349626

familia API

isomalt

CofA

current certificate can be downloaded

envase

pkg of 1 g

técnicas

HPLC: suitable
gas chromatography (GC): suitable

aplicaciones

pharmaceutical (small molecule)

formato

neat

temp. de almacenamiento

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

Clave InChI

SERLAGPUMNYUCK-BLEZHGCXSA-N

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Descripción general

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.

Aplicación

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.

Nota de análisis

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

Otras notas

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.

Nota al pie de página

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.

Producto relacionado

Referencia del producto
Descripción
Precios

Código de clase de almacenamiento

11 - Combustible Solids

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


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Los clientes también vieron

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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