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Key Documents

PHR1025

Supelco

Lactose, Anhydrous

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Lactose

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About This Item

Empirical Formula (Hill Notation):
C12H22O11
CAS Number:
Molecular Weight:
342.30
Beilstein:
93796
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. A1206000
traceable to USP 1356676

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
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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/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/t4-,5+,6+,7+,8-,9-,10+,11+,12-/m0/s1

InChI key

DKXNBNKWCZZMJT-JVCRWLNRSA-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, Anhydrous may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
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 LRAB2931 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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The influence of carrier and drug morphology on drug delivery from dry powder formulations
Larhrib H, et al.
International Journal of Pharmaceutics, 257(1-2), 283-296 (2003)
Assessment of feasibility of Maillard reaction between baclofen and lactose by liquid chromatography and tandem mass spectrometry, application to pre formulation studies
Monajjemzadeh F, et al.
Aaps Pharmscitech, 10(2), 649-659 (2009)
Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets
Monajjemzadeh F, et al.
European Journal of Pharmaceutics and Biopharmaceutics, 73(3), 404-413 (2009)
Martin Andreas Wälti et al.
Journal of molecular biology, 379(1), 146-159 (2008-04-29)
Recent advances in genome sequencing efforts have revealed an abundance of novel putative lectins. Among these, many galectin-related proteins, characterized by many conserved residues but intriguingly lacking critical amino acids, have been found in all corners of the eukaryotic superkingdom.
Thao T Le et al.
Food chemistry, 141(2), 1203-1210 (2013-06-26)
Lactosylation in stored milk powder was quantified by multiple reaction monitoring (MRM), a mass spectrometry-based quantification method. The MRM method was developed from a knowledge of peptide fragmentation. The neutral losses of 162Da (cleavage of galactose) and 216Da (the formation

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