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Lactose (Monohydrate)

Pharmaceutical Secondary Standard; Certified Reference Material

4-O-β-D-Galactopyranosyl-D-glucose, Milk sugar, β-D-Gal-(1→4)-D-Glc, D-Lactose monohydrate
Empirical Formula (Hill Notation):
C12H22O11 · H2O
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard




current certificate can be downloaded

analyte chemical class(es)



HPLC: suitable
detection: suitable
gas chromatography (GC): suitable
ion chromatography: suitable

Featured Industry

Cleaning Products
Food and Beverages
Personal Care
Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to PhEur Y0001750
traceable to USP 1356701

storage temp.

room temp

SMILES string




InChI key


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

Storage Class Code

13 - Non Combustible Solids



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Determination of trans-galactooligosaccharides in selected food products by ion-exchange chromatography: collaborative study
Journal of AOAC (Association of Official Analytical Chemists) International, 85, 417-423 (2002)
Fan Zhou et al.
Scientific reports, 1, 78-78 (2012-02-23)
The invisibility cloak has been a long-standing dream for many researchers over the decades. Using transformation optics, a three-dimensional (3D) object is perceived as having a reduced number of dimensions, making it "undetectable" judging from the scattered field12345. Despite successful...
J Nijdam et al.
Colloids and surfaces. B, Biointerfaces, 123, 53-60 (2014-09-30)
Segregation of the protein bovine serum albumin (BSA) and lactose in thin aqueous films during drying was investigated by examining the composition of the dried films using inverse micro Raman spectroscopy (IMRS) and X-ray photoelectron spectroscopy (XPS) sputter-depth profiling. The...
Akhtar Siddiqui et al.
Journal of pharmaceutical sciences, 103(9), 2819-2828 (2014-03-04)
The objective of this study was to develop powder X-ray diffraction (XRPD) chemometric model for quantifying crystalline tacrolimus from solid dispersion (SD). Three SDs (amorphous tacrolimus component) with varying drug to excipient ratios (24.4%, 6.7%, and 4.3% drug) were prepared....
Naser Tavakoli et al.
Journal of microencapsulation, 31(6), 529-534 (2014-04-05)
Repaglinide, an oral antidiabetic agent, has a rapid onset of action and short half-life of approximately 1 h. Designing a controlled release dosage form of the drug is required to maintain its therapeutic blood level and to eliminate its adverse effects...


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