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PHR1497

Supelco

Maltose Monohydrate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

D-Maltose monohydrate, 4-O-α-D-Glucopyranosyl-D-glucose, D-(+)-Maltose monohydrate, Maltobiose

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About This Item

Formule empirique (notation de Hill):
C12H22O11 · H2O
Numéro CAS:
Poids moléculaire :
360.31
Numéro Beilstein :
93798
Numéro CE :
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

traceable to USP 1375025

Famille d'API

maltose

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Pf

119-121 °C (dec.) (lit.)

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

O.OC[C@@H](O)[C@@H](O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)[C@H](O)[C@@H](O)C=O

InChI

1S/C12H22O11.H2O/c13-1-4(16)7(18)11(5(17)2-14)23-12-10(21)9(20)8(19)6(3-15)22-12;/h1,4-12,14-21H,2-3H2;1H2/t4-,5+,6+,7+,8+,9-,10+,11+,12+;/m0./s1

Clé InChI

HBDJFVFTHLOSDW-DNDLZOGFSA-N

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Description générale

Maltose monohydrate is commonly used as a tablet filler or excipient in pharmaceutical industry.
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

Maltose Monohydrate may be used as a pharmaceutical reference standard for the determination of the analyte in drug mixtures by simulated moving bed chromatography. It may also be used as a tablet filler with bisoprolol fumarate drug.
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.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAC2890 in the slot below. This is an example certificate only and may not be the lot that you receive.

Produit(s) apparenté(s)

Réf. du produit
Description
Tarif

Code de la classe de stockage

13 - Non Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 1

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Systematic optimization and experimental validation of ternary simulated moving bed chromatography systems
Agrawal G, et al.
Journal of Chromatography A, 1356, 82-95 (2014)
Mateusz Szalka et al.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 59, 1-11 (2014-04-22)
HPLC analysis of drug products containing bisoprolol fumarate and lactose revealed the presence of N-formylbisoprolol, which is a final product of the Maillard reaction. Formulations containing secondary amines and reducing carbohydrates are prone to the condensation of amine and carbonyl

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