PHR1024

Lactose (Monohydrate)

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): D-Lactose monohydrate, β-D-Gal-(1→4)-D-Glc, 4-O-β-D-Galactopyranosyl-D-glucose, Milk sugar
• Empirical Formula (Hill Notation): C₁₂H₂₂O₁₁ · H₂O
• CAS Number: 64044-51-5
• Molecular Weight: 360.31
• Beilstein: 3768231
• EC Number: 200-559-2
• MDL number: MFCD00166994
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823054
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001750; traceable to USP 1356701
• API family: lactose
• CofA: current certificate can be downloaded
• analyte chemical class(es): oligosaccharides
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): cleaning products; cosmetics; detection; environmental; food and beverages; personal care; 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-XBLONOLSSA-N

Description

General description

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

Lactose (monohydrate) may be used as a reference standard in determining the amount of lactose (monohydrate) present in food samples using high performance anion exchange chromatography (HPIEC) with pulsed amperometric detection.

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 (PhEur) 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 LRAC3265 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable