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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
Empirical Formula (Hill Notation):
C12H22O11 · H2O
CAS Number:
Molecular Weight:
360.31
Beilstein:
3768231
MDL number:
PubChem Substance ID:
NACRES:
NA.24

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

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

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This Item
PHR10241.3704561341
Lactose monohydrate United States Pharmacopeia (USP) Reference Standard

USP

1356701

Lactose monohydrate

Lactose (Monohydrate) Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1024

Lactose (Monohydrate)

Lactose monohydrate powder, EMPROVE® EXPERT, Ph. Eur., BP, ChP, NF, JP

SAFC

1.37045

Lactose monohydrate

D-Lactose monohydrate tested according to Ph. Eur.

Sigma-Aldrich

61341

D-Lactose monohydrate

manufacturer/tradename

USP

manufacturer/tradename

-

manufacturer/tradename

EMPROVE® EXPERT

manufacturer/tradename

-

application(s)

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

application(s)

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

application(s)

-

application(s)

-

format

neat

format

neat

format

-

format

-

API family

lactose

API family

lactose

API family

-

API family

-

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.

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

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.  ​

Other Notes

USP issued SDS can be found here.
Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

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Lactose monohydrate

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Lactose monohydrate

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Sigma-Aldrich

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Galactose
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 34(3), 2953-2953 (2018)
Lactose monohydrate
United States Pharmacopeia and National Formulary
United States Pharmacopeia, 46(5), 5849-5849 (2020)
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
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.

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