PHR1769

Isomalt

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonim(y): Isomalt, 6-O-α-D-Glucopyranosyl-D-glucitol mixed with 1-O-α-D-glucopyranosyl-D-mannitol
• Wzór empiryczny (zapis Hilla): C₁₂H₂₄O₁₁
• Numer CAS: 64519-82-0
• Masa cząsteczkowa: 344.31
• Kod UNSPSC: 41116107
• NACRES: NA.24

Właściwości

• klasa czystości: certified reference material; pharmaceutical secondary standard
• Poziom jakości: 300
• agency: traceable to Ph. Eur. I0465000; traceable to USP 1349626
• rodzina API: isomalt
• Certyfikat analizy: current certificate can be downloaded
• opakowanie: pkg of 1 g
• metody: HPLC: suitable; gas chromatography (GC): suitable
• Zastosowanie: pharmaceutical (small molecule)
• format: neat
• temp. przechowywania: 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
• Klucz InChI: SERLAGPUMNYUCK-BLEZHGCXSA-N

Opis

Opis ogólny

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.

Zastosowanie

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.

Komentarz do analizy

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

Inne uwagi

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.

Przypis

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.

Informacja o środkach bezpieczeństwa

• Kod klasy składowania: 11 - Combustible Solids
• Klasa zagrożenia wodnego (WGK): WGK 3
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable