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PHR1024

Supelco

Lactose (Monohydrate)

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

D-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
Beilstein/REAXYS Number:
3768231
EC Number:
200-559-2
MDL number:
MFCD00166994
UNSPSC Code:
41116107
PubChem Substance ID:
329823054
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

agency

traceable to Ph. Eur. Y0001750
traceable to USP 1356701

API family

lactose

CofA

current certificate can be downloaded

analyte chemical class(es)

oligosaccharides

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

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

format

neat

storage temp.

2-30°C

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

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.

Application

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.

Footnote

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

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD3323
LRAC9562
LRAC4109
LRAC3265
LRAA8961

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D-Lactose monohydrate ≥99% (HPLC), BioUltra

Sigma-Aldrich

61339

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Lactose (anhydrous) European Pharmacopoeia (EP) Reference Standard

A1206000

Lactose (anhydrous)

Anhydrous lactose United States Pharmacopeia (USP) Reference Standard

USP

1356676

Anhydrous lactose

Maltose Monohydrate Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1497

Maltose Monohydrate

D-Lactose monohydrate tested according to Ph. Eur.

Sigma-Aldrich

61341

D-Lactose monohydrate

α-Lactose monohydrate ≥99% total lactose basis (GC)

Sigma-Aldrich

L3625

α-Lactose monohydrate

D-Lactose monohydrate ACS reagent

Sigma-Aldrich

L254

D-Lactose monohydrate

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

SAFC

1.07656

Lactose monohydrate

Lactose monohydrate (milk sugar) special grade for tabletting, EMPROVE® ESSENTIAL, Ph. Eur., BP, JP, NF

SAFC

1.08195

Lactose monohydrate

Millipore

Millipore

1.07660

Lactose monohydrate

Determination of trans-galactooligosaccharides in selected food products by ion-exchange chromatography: collaborative study
Slegte.DJ
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
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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