Histamine H1 receptor
antagonists or antihistamines are the class of drugs used in the treatment of
allergic disorders. They are classified as
first generation sedating and second-generation non-sedating antihistamine. The
non-sedation antihistamines do not easily cross the blood-brain barrier causing
lesser or no drowsiness and thereby improving the lives of the patients.
Cetirizine, which was approved as a second-generation
non-sedating antihistamine by FDA in September 1996 is one of the most commonly
prescribed drugs for all ages by the medical practitioners.
Cetirizine, available as dihydrochloride
salt works by blocking one type of receptor for histamine (the H1 receptor) and
thus preventing the activation of H1 receptor-containing cells by histamine (a
chemical that is responsible for many of the signs and symptoms of allergic reactions).
Chemically,
Cetirizine Dihydrochloride is [2-[4-[(4-Chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic
Acid Dihydrochloride and it is a bioactive carboxylated metabolite of
hydroxyzine.Cetirizine is a racemic compound and its organic synthesis involves
several stereochemical steps which result in a number of impurities along with
the desired products.
Identification,
isolation, and characterization of these impurities is an indispensable process
for Pharmaceutical companies, as these impurities may change the effectiveness
and efficacy of the drug product.
Pharmaffiliates
Analytics and Synthetics P. Ltd. have successfully performed impurity profiling
of Cetirizine impurities and reference standards of these impurities are
readily available in pack sizes of 25 and 50mg vials at Pharmaffiliates.
Detailed of Cetirizine
impurities are listed below
Name
of the impurity
|
Product
code
|
CAS
No.
|
Description
|
Cetirizine
Dihydrochloride
|
PA 03 36000
|
83881-52-1
|
Second
generation antihistamine
|
PA 03 36010
|
303-26-4
|
Starting
material used in the synthesis
|
|
PA 03 36020
|
113740-61-7
|
A
Decarbomethoxy impurity formed during synthesis
|
|
PA 03 36030/ PA 03 36031 (Freebase form)
|
83881-59-8/NA
|
2-chloro
impurity formed during synthesis
|
|
PA 03 36040
|
346451-15-8
|
Dimer
impurity of Cetirizine
|
|
PA 03 36050/ PA 03 36051 (Freebase form)
|
83881-56-5/NA
|
Impurity
formed during synthesis
|
|
PA 03 36060/ PA 03 36061 (Freebase form)
|
83881-54-3/ 83881-53-2
|
Deschloro
impurity
|
|
PA 03 36070/ PA 03 36071 (Freebase form)
|
164726-80-1/ 109806-71-5
|
Important
intermediate formed during synthesis
|
|
PA 03 36590
|
NA
|
A
lactose adduct of Cetirizine
|
For more details and other impurities
click on the link below
All the above-mentioned impurity
standards are available along with a Certificate of Analysis along with the
detailed chromatograms and spectroscopic data.
Pharmaffiliates is well-known name as an
integrated CRO globally which specializes in the field of Custom synthesis of
products which includes Reference standards, impurities, Iso-labeled compounds,
Phyto standards, pesticides, agrochemicals, food, cosmetics and many more.
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