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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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

Description

General description

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

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.[2] It may also be used as a tablet filler with bisoprolol fumarate drug.[1]

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, EP and BP 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.

Footnote

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.

Safety Information

• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable