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PHR1376

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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:
Molecular Weight:
382.88
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 874
traceable to Ph. Eur. Y0000688
traceable to USP 1370270

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

SMILES string

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

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

InChI key

JCCNYMKQOSZNPW-UHFFFAOYSA-N

Gene Information

human ... HRH1(3269)

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General description

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

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.

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 LRAC3785 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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Determination of loratadine in pharmaceuticals by a spectrophotometric method
Pavalanche G, et al.
Ovidius University Annals of Chemistry, 26(1), 27-31 (2015)
E W Monroe
Clinical therapeutics, 19(2), 232-242 (1997-03-01)
Urticaria is a common skin disease, which in its chronic form, is a very disturbing condition. Because histamine is the best-documented chemical mediator of urticaria, histamine-antagonists are the mainstay of therapy. First-generation antihistamines are limited by their tendency to produce
M R Namazi
Journal of the European Academy of Dermatology and Venereology : JEADV, 19(3), 319-322 (2005-04-29)
As the current antipsoriatic medications are commonly associated with deleterious side-effects, a determined search for safer agents, which could be used alone or in combination with current antipsoriatic drugs, would be very imperative. Psoriasis is believed to be characterized by
M Haria et al.
Drugs, 48(4), 617-637 (1994-10-01)
Loratadine is a long-acting antihistamine agent, exhibiting partial selectivity for peripheral histamine H1-receptors. To date, loratadine has been evaluated in allergic rhinitis, urticaria and, to a limited extent, in asthma. In several large controlled comparative clinical studies, loratadine was superior
I J Roman et al.
Clinical reviews in allergy, 11(1), 89-110 (1993-01-01)
Antihistamines are considered first-line therapy for the relief of symptoms from allergic rhinitis and chronic urticaria. The newer, second-generation, nonsedating antihistamines reduce the central nervous system and anticholinergic side effects commonly found with previous drugs. The availability of H1-receptor antagonists

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