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PHR1024

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

Key Documents

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Product Name

Lactose (Monohydrate), Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

HBDJFVFTHLOSDW-XBLONOLSSA-N

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

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

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

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.

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.

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

11 - Combustible Solids

wgk

WGK 3

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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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
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.
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
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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