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PHR1376

Loratadine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Loratadine, 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene-1-piperidinecarboxylic acid ethyl ester, Loratidine

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About This Item

Empirical Formula (Hill Notation):
C22H23N2O2Cl
CAS Number:
79794-75-5
Molecular Weight:
382.88
NACRES:
NA.24
PubChem Substance ID:
329823353
UNSPSC Code:
41116107
MDL number:
MFCD00672869

Key Documents

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Product Name

Loratadine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C22H23ClN2O2/c1-2-27-22(26)25-12-9-15(10-13-25)20-19-8-7-18(23)14-17(19)6-5-16-4-3-11-24-21(16)20/h3-4,7-8,11,14H,2,5-6,9-10,12-13H2,1H3

SMILES string

CCOC(=O)N1CC\C(CC1)=C2/c3ccc(Cl)cc3CCc4cccnc24

InChI key

JCCNYMKQOSZNPW-UHFFFAOYSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

USP 1370270
traceable to Ph. Eur. Y0000688

API family

loratadine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... HRH1(3269)

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Analysis Note

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

Application

Loratadine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric technique.
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.

Biochem/physiol Actions

Non-sedating histamine H1-receptor antagonist.

General description

Loratadine belongs to the class of H1-antihistamine drugs, with non-sedating properties, and is widely used in the treatment of allergies.

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 LRAC3785 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

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 loratadine in pharmaceuticals by a spectrophotometric method
Pavalanche G, et al.
Ovidius University Annals of Chemistry, 26(1), 27-31 (2015)
Eleanor B Schwarz et al.
Drug safety, 31(9), 775-788 (2008-08-19)
Loratadine, a second-generation antihistamine, is commonly used to treat seasonal allergies. Some studies have suggested that use of loratadine by pregnant women increases the risk of hypospadias in male offspring. This meta-analysis was designed to assess the strength of the
J L Menardo et al.
Clinical therapeutics, 19(6), 1278-1293 (1998-01-28)
Patients with seasonal or allergic bronchial asthma experience an immediate allergic response caused by allergen-specific immunoglobulin E-mediated histamine release. The release of histamine and other chemical mediators may trigger airway hyperresponsiveness and exaggerated bronchoconstriction, characteristic features of allergic bronchial asthma.
Prescrire international, 19(105), 26-28 (2010-05-12)
Some antihistamines, such as mizolastine and ebastine, can prolong the QT interval and provoke severe cardiac arrhythmias. This review examines the effects of two widely used antihistamines, cetirizine and loratadine, on the QT interval. As of mid 2009 very few
J A Hey et al.
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 29 Suppl 3, 197-199 (1999-08-12)
The extremely low reporting rate of cardiovascular adverse events for loratadine, the possible preferential use of loratadine in patients with pre-existing cardiovascular disorders, and the impressive lack of cardiovascular effects at extremely high concentrations in clinical and preclinical studies demonstrate
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