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PHR1497

Maltose Monohydrate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C12H22O11 · H2O
CAS Number:
6363-53-7
Molecular Weight:
360.31
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823418
EC Number:
200-716-5
Beilstein/REAXYS Number:
93798
MDL number:
MFCD00149343
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1375025

API family

maltose

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

119-121 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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

InChI key

HBDJFVFTHLOSDW-DNDLZOGFSA-N

General description

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.

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 LRAC2890 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Storage Class

13 - Non Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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

Global Trade Item Number

SKUGTIN
PHR1497-1G04061835237807