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Merck
CN

PHR1680

Desloratidine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Desloratadine, 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H- benzo[5,6]cyclohepta[1,2,b]pyridine, Clarinex®, NSC 675447

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About This Item

Empirical Formula (Hill Notation):
C19H19ClN2
CAS Number:
100643-71-8
Molecular Weight:
310.82
NACRES:
NA.24
PubChem Substance ID:
329823552
UNSPSC Code:
41116107
MDL number:
MFCD00871949

Key Documents

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InChI

1S/C19H19ClN2/c20-16-5-6-17-15(12-16)4-3-14-2-1-9-22-19(14)18(17)13-7-10-21-11-8-13/h1-2,5-6,9,12,21H,3-4,7-8,10-11H2

SMILES string

Clc1ccc2c(CCc3cccnc3\C2=C4\CCNCC4)c1

InChI key

JAUOIFJMECXRGI-UHFFFAOYSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001584, traceable to USP 1173042

API family

desloratidine

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.

2-30°C

Quality Level

300

Gene Information

human ... HRH1(3269)

Related Categories

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.
Desloratadine is one of the orally active, highly selective peripheral H1 receptor antagonists that does not exert any significant effect on the central and autonomic nervous systems. The potency of desloratadine is more than that of loratadine and it exhibits substantial overall pharmacological profile.

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.
Desloratadine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by various chromatography techniques.

Biochem/physiol Actions

A non-sedating H1-receptor antagonist, free from antimuscarinic/anticholinergic effects. It has novel antiallergic and anti-inflammatory effects.
Desloratadine is a selective and nonsedating histamine H1 receptor antagonist, an active metabolite of loratadine (Claritin), used to relieve hay fever and allergy symptoms with less drowsiness than other antihistamines; does not significantly inhibits cardiac K+ channels at clinically achievable blood levels. Free from antimuscarinic/anticholinergic effects.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 LRAC2775 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Legal Information

Clarinex is a registered trademark of Schering Corp.

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

390.2 °F - Pensky-Martens closed cup

flash_point_c

199 °C - Pensky-Martens closed cup

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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A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms.
Rao DD, et al.
Journal of Pharmaceutical and Biomedical Analysis, 51(3), 736-742 (2010)
Spectrophotometric, spectrofluorometric and HPLC determination of desloratadine in dosage forms and human plasma.
El-Enany N, et al.
Chemical & Pharmaceutical Bulletin, 55(12), 1662-1670 (2007)
High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs.
Liu L, et al.
Journal of Pharmaceutical and Biomedical Analysis, 34(5), 1013-1019 (2004)
Determination of desloratadine in drug substance and pharmaceutical preparations by liquid chromatography.
Qi M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 38(2), 355-359 (2005)

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