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Documenti fondamentali

PHR1497

Supelco

Maltose Monohydrate

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

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

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About This Item

Formula empirica (notazione di Hill):
C12H22O11 · H2O
Numero CAS:
Peso molecolare:
360.31
Beilstein:
93798
Numero CE:
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to USP 1375025

Famiglia di API

maltose

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

Punto di fusione

119-121 °C (dec.) (lit.)

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-30°C

Stringa SMILE

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
HBDJFVFTHLOSDW-DNDLZOGFSA-N

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Descrizione generale

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.

Applicazioni

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.

Risultati analitici

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

Altre note

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 a piè di pagina

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.

Prodotti correlati

N° Catalogo
Descrizione
Determinazione del prezzo

Codice della classe di stoccaggio

13 - Non Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 1

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

Lot/Batch Number

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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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