PHR1769

Isomalt

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): Isomalt, 6-O-α-D-Glucopyranosyl-D-glucitol mixed with 1-O-α-D-glucopyranosyl-D-mannitol
• Fórmula empírica (Notação de Hill): C₁₂H₂₄O₁₁
• Número CAS: 64519-82-0
• Peso molecular: 344.31
• Código UNSPSC: 41116107
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. I0465000; traceable to USP 1349626
• família API: isomalt
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 1 g
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-8°C
• cadeia de caracteres SMILES: 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
• chave InChI: SERLAGPUMNYUCK-BLEZHGCXSA-N

Descrição

Descrição geral

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.[1]
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.

Aplicação

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).[1] 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.[2]

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 análise

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

Outras 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 de rodapé

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.

Informações de segurança

• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable