The
taxane family of terpenes has received much attention in the scientific and
medical community, because members of this family have demonstrated broad
spectrum of anti-leukemic and tumor-inhibitory activity.
Cabazitaxel, which was developed by
Sanofi-Aventis is one of the semi-synthetic derivative of Taxol family and it
was approved by U.S FDA for the treatment of hormone-refractory prostate cancer.
Cabazitaxel is a novel tubulin-binding taxane and fourth taxane to be
approved for
cancer therapy. Synthesis of Cabazitaxel includes semi-synthesis of naturally
occurring
taxoid, 10-deacetylbaccatin III (10-DAB) with potentially unique anti-neoplastic
activity for a variety of tumors.
A number
of other intermediates, impurities, metabolites and degradants are also
associated with Cabazitaxel, many of them were identified and synthesized at Pharmaffiliates Analytics and Synthetics P.
Ltd.
Impurities
available at Pharmaffiliates are mentioned and classified as below:
1. De-Boc Cabazitaxel- an impurity formed in the
commercial synthesis of Cabazitaxel.
2. 10-Deacetyl-7,10-Dimethoxy-Baccatin III- an intermediate formed from naturally occurring taxoid 10-DAB which is
used as a starting material in the synthesis of Cabazitaxel.
3. Cabazitaxel N-Formyl impurity - an impurity formed in the
commercial synthesis of Cabazitaxel.
4. 10-Deacetyl-7,10,13-Trimethyl Baccatin III- an intermediate formed from naturally
occurring taxoid 10-DAB which is used as a starting material in the synthesis
of Cabazitaxel.
5. (2'S, 3'R)-Cabazitaxel – a stereoisomer of Cabazitaxel.
6. Cabazitaxel Di Boc Impurity- an impurity formed in the commercial synthesis of Cabazitaxel.
7. Oxazolidine Cabazitaxel - an impurity formed in the
commercial synthesis of Cabazitaxel.
8. (4S, 5S)-3-(tert-Butoxycarbonyl)-2-(4-Methoxyphenyl)-4-Phenyloxazolidine-5-Carboxylic
acid -
Cabazitaxel Impurity 20
9. (4R, 5R)-3-(tert-Butoxycarbonyl)-2-(4-Methoxyphenyl)-4-Henyloxazolidine-5-Carboxylic
acid -
Cabazitaxel Impurity 22
All the above mentioned compounds are
available at Pharmaffiliates in a pack size of 25mg and 50 mg. Customized pack sizes are also
available as per the customer’s
need.
Majority of the above mentioned impurities synthesized at Pharmaffiliates
are 98% pure and each
of these standards synthesized at Pharmaffiliates are been identified through
an elaborate structure elucidation data and certificate of analysis is provided
for the same.
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