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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关于此项目
Quality Level
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
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
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.
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.
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
涉药品监管产品
此项目有
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
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| PHR1769-1G | 04061835080052 |