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Merck
CN

PHR1608

Lactulose

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Lactulose, 4-O-β-D-Galactopyranosyl-D-fructofuranose, 4-O-β-D-Galactopyranosyl-D-fructose

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About This Item

Empirical Formula (Hill Notation):
C12H22O11
CAS Number:
4618-18-2
Molecular Weight:
342.30
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823505
EC Number:
225-027-7
Beilstein/REAXYS Number:
93773
MDL number:
MFCD00151469

Key Documents

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Product Name

Lactulose, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

JCQLYHFGKNRPGE-WJONTELPSA-N

InChI

1S/C12H22O11/c13-1-4-6(16)7(17)8(18)11(21-4)22-9-5(2-14)23-12(20,3-15)10(9)19/h4-11,13-20H,1-3H2/t4-,5-,6+,7+,8-,9-,10+,11+,12+/m1/s1

SMILES string

OC[C@H]1O[C@@H](O[C@@H]2[C@@H](CO)O[C@@](O)(CO)[C@H]2O)[C@H](O)[C@@H](O)[C@H]1O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. L0130000
traceable to USP 1356803

API family

lactulose

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

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

Application

Lactulose may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various 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.

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.
Lactulose is a disaccharide that finds immense applications in medicine, nutrition and dairy technology. It is utilized as a medicine in the treatment of portal systemic encephalopathy and chronic constipation.

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 LRAB7605 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 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
This item has

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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Chromatographic determination of lactulose
Martinez-Castro I, et al.
Chromatographia, 23(2), 132-136 (1987)
Use of an automated robotic system for the extraction and on-line high-performance liquid chromatographic analysis of pharmaceutical formulations
Van der Voorden EC, et al.
Chemometrics and Intelligent Laboratory Systems, 17(1), 129-135 (1992)
J Zhao et al.
Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society, 26(6), 794-802 (2014-03-20)
Small intestinal bacterial overgrowth (SIBO) may be a cause of irritable bowel syndrome (IBS); however, current investigations have important limitations. We aimed to identify clinically relevant diagnostic criteria for SIBO based on lactulose hydrogen breath test (LHBT) alone and combined
A A Guerra-Ordaz et al.
Applied and environmental microbiology, 80(16), 4879-4886 (2014-06-08)
The potential of a prebiotic oligosaccharide lactulose, a probiotic strain of Lactobacillus plantarum, or their synbiotic combination to control postweaning colibacillosis in pigs was evaluated using an enterotoxigenic Escherichia coli (ETEC) K88 oral challenge. Seventy-two weanlings were fed four diets:
Kostan W Reisinger et al.
Journal of pediatric gastroenterology and nutrition, 59(6), 720-724 (2014-08-12)
The incidence of necrotizing enterocolitis (NEC) is higher in formula-fed babies than in breast-fed babies, which may be caused by breast-feeding-induced gut maturation. The effect of breast-feeding on gut maturation has been widely studied in animal models. This study aimed
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