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PHR1024 Supelco

Lactose (Monohydrate)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: β-D-Gal-(1→4)-D-Glc, 4-O-β-D-Galactopyranosyl-D-glucose, D-Lactose monohydrate, Milk sugar

  • CAS Number 64044-51-5

  • Empirical Formula (Hill Notation) C12H22O11 · H2O

  • Molecular Weight 360.31

  •  Beilstein/REAXYS Number 3768231

  •  EC Number 200-559-2

  •  MDL number MFCD00166994

  •  PubChem Substance ID 329823054



Related Categories Additional Standards, Analytical Standards, Analytical/Chromatography, Carbohydrate Standards, Chromatography,
grade   certified reference material
  pharmaceutical secondary standard
form   neat
Featured Industry   Cosmetics, Personal Care, and Cleaning Products
Food and Beverages
Pharmaceutical (small molecule)
analyte suitability   oligosaccharides
format   neat
pharmacopeia traceability   traceable to PhEur L0100000
  traceable to USP 1356701


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.


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.


To see an example of a Certificate of Analysis for this material enter LRAA8961 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety & Documentation

Safety Information

NONH for all modes of transport
WGK Germany 


Certificate of Analysis

Please Enter a Lot Number
Protocols & Articles


An Alternative to the USP and EP Methods for the Analysis of Riboflavin (Vitamin B2)

An alternative to the cumbersome USP and EP methods using LC/MS/MS detection and a Titan C18 UHPLC column to identify riboflavin and its impurities is described here. This new method is also compatib...
Nicolas J. Hauser, Carmen T. Santasania
Reporter US Volume 33.3
Keywords: Chromatography, Degradations, Detection methods, Eliminations, High performance liquid chromatography, Mass spectrometry, Metabolism, Oxidations, Sonication, Ultraviolet-Visible spectroscopy, Vitamins

Peer-Reviewed Papers


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