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Merck

PHR1024

Lactose (Monohydrate)

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

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

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Fórmula empírica (notación de Hill):
C12H22O11 · H2O
Número CAS:
64044-51-5
Peso molecular:
360.31
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823054
EC Number:
200-559-2
Beilstein/REAXYS Number:
3768231
MDL number:
MFCD00166994

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Quality Level

300

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

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

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.
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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.
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.

Clase de almacenamiento

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «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)
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.
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
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