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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

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About This Item

Empirical Formula (Hill Notation):
C12H22O11 · H2O
CAS Number:
Molecular Weight:
360.31
Beilstein/REAXYS Number:
3768231
MDL number:
UNSPSC Code:
41116107
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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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

Sales restrictions may apply.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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
Pramod K Mistry et al.
JAMA, 313(7), 695-706 (2015-02-18)
Gaucher disease type 1 is characterized by hepatosplenomegaly, anemia, thrombocytopenia, and skeletal disease. A safe, effective oral therapy is needed. To determine whether eliglustat, a novel oral substrate reduction therapy, safely reverses clinical manifestations in untreated adults with Gaucher disease

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