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Merck
CN

1356701

USP

Lactose monohydrate

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C12H22O11 · H2O
CAS Number:
64044-51-5
Molecular Weight:
360.31
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329750222
MDL number:
MFCD00166994
Beilstein/REAXYS Number:
3768231

Key Documents

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Product Name

Lactose monohydrate, United States Pharmacopeia (USP) Reference Standard

InChI key

HBDJFVFTHLOSDW-XBLONOLSSA-N

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

grade

pharmaceutical primary standard

API family

lactose

manufacturer/tradename

USP

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

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Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Application

Lactose monohydrate USP reference standard for use in specified quality tests and assays.

Also used to prepare the standard solution for identification by thin-layer chromatography (TLC) according to the given below monographs of United States Pharmacopeia(USP):
  • Lactose monohydrate
  • Galactose

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.
Lactose Monohydrate is the monohydrate of O-β-d-galactopyranosyl-(1→4)-α-D-glucopyranose.

Other Notes

Sales restrictions may apply.

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

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Lactose monohydrate
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 46(5), 5849-5849 (2020)
Galactose
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(3), 2953-2953 (2018)
Tamás Firkala et al.
Journal of pharmaceutical and biomedical analysis, 107, 318-324 (2015-02-01)
This paper reports the application of surface enhanced Raman chemical imaging (SER-CI) as a potentially non-destructive quantitative analytical method for the investigation of model pharmaceutical formulations containing the active pharmaceutical ingredient (API) in low concentrations (0.5-2%). The application of chemometric
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.
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
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