An atypical antipsychotic, Quetiapine is a dibenzothiazepine derivative which is available in different pharmaceutical forms.
Quetiapine is frequently used for the treatment of delirium and behavioral and psychological symptoms in dementia. Delirium is an acute disorder of attention and cognition, more frequent in elderly people. It is also known as second generation antipsychotic (SGA).
In April 2019, use of Quetiapine was approved by the US Food and Drugs Administration and several European regulatory agencies for treatment of schizophrenia, bipolar disorder and major depressive disorder.
Quetiapine which exists as fumarate or acetate salt is manufactured by big pharmaceutical giants in the form of immediate-release (IR) and extended-release (XR) depending upon the desired therapeutic action for the delivery.
In order to ensure a high degree of purity of drug substances and drug products, a scheme is proposed for profiling drug impurity as per the ICH guidelines. To purify a material and remove the excess impurities one should first recognize that whether they are actually present and what their nature is.
Many potential impurities including by-products, starting materials, metabolites and intermediates were identified in pharmaceutical substance quetiapine and characterized by spectroscopic methods (MS, IR, NMR).
The Impurity Reference Standards (IRSs) of these impurities must be designed to detect, identify, quantify and qualify impurities in a drug substance in accordance with the ICH guidelines (Q3A to Q3D and Q7).
Some of the known and unknown impurities of Quetiapine are listed below:
|Product Code||Chemical Name||Product Name||CAS No.|
|PA 17 02000||Quetiapine||Quetiapine - API||111974-69-7|
|PA 17 02010||Quetiapine Acetate||Quetiapine - Impurity A||844639-07-2|
|PA 17 02020||11-(piperazin-1-yl)dibenzo[b,f][1,4]thiazepineDihydrochloride||Quetiapine - Impurity B||111974-74-4|
|PA 17 02030||2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethyl [4-(dibenzo[b,f][1, 4]thiazepin-11-yl)piperazin-1-yl]acetate||Quetiapine - Impurity C||1798840-31-9|
|PA 17 02040||Quetiapine Dimer Impurity||Quetiapine - Impurity D||945668-94-0|
|PA 17 02050||Quetiapine bis-Ether||Quetiapine - Impurity E||1371638-05-9|
|PA 17 02060||[2-[(2-aminophenyl)sulfanyl]phenyl][4-[2-(2-hydroxyethoxy)ethyl]piperazin-1-yl]methanone||Quetiapine - Impurity F||848814-27-7|
|PA 17 02070||Quetiapine Lactam||Quetiapine - Impurity G||3159-07-7|
|PA 17 02080||Quetiapine N-Oxide||Quetiapine - Impurity H||1076199-40-0|
|PA 17 02090||2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethanol||Quetiapine - Impurity I||329216-67-3|
|PA 17 02100||2-[2-[2-[2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy]ethoxy]ethoxy]ethanol||Quetiapine - Impurity J||1356906-17-6|
|PA 17 02110||N-(2-((2-(4-(2-(2-Hydroxyethoxy)ethyl)piperazine-1-carbonyl)phenyl)thio)phenyl)acetamide||Quetiapine - Impurity K||1371638-10-6|
|PA 17 02120||9-Chloro Quetiapine||Quetiapine - Impurity L||1371638-11-7|
|PA 17 02140||2-(2-(4-(2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl)piperazin-1-yl)ethoxy)ethanol||Quetiapine - Impurity N||1800291-86-4|
|PA 17 02150||Quetiapine O-Trityl Impurity||Quetiapine - Impurity O||844639-06-1|
|PA 17 02160||Quetiapine N-Ethyl Impurity||Quetiapine - Impurity P||1011758-03-4|
|PA 17 02161||Quetiapine N-Ethyl Dihydrochloride Impurity||Quetiapine - Impurity P (Dihydrochloride Salt)||NA|
|PA 17 02170||4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1,1-bis[2-(2-hydroxyethoxy)ethyl]piperazin-1-ium||Quetiapine - Impurity Q||NA|
|PA 17 02180||Fumaric Acid Monoethyl Ester||Quetiapine - Impurity R||2459-05-4|
|PA 17 02190||Quetiapine Sulfoxide||Quetiapine - Impurity S||329216-63-9|
|PA 17 02200||Quetiapine Morpholine Impurity||Quetiapine - Impurity T||5747-46-6|
|PA 17 02210||Dibenzo[b,f][1,4]thiazepin-11-amine||Quetiapine - Impurity U||5786-26-5|
|PA 17 02220||2-(2-(4-Phenanthridin-6-yl)piperazin-1-yl)ethoxy)ethanol||Quetiapine - Impurity V||NA|
|PA 17 02230||11-(2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethoxy) dibenzo[b,f][1,4]thiazepine||Quetiapine - Impurity W||1800608-95-0|
To procure a reliable Impurity Reference Standard (IRS) a trusted Certificate of Analysis along with all the supporting documents must be provided by the source. Also, the information provided on the CoA should be suitable with regard to the specific use planned for the corresponding RS.
Pharmaffiliates Analytics and Synthetics Pvt. Ltd. is a trusted partner in the Pharmaceutical parlance as an Impurity Reference Standard manufacturer, supplier, and exporter.
Apart from IRSs, Pharmaffiliates also deals in Primary Reference standards, Secondary Reference Standards, Pharmacopeial Reference Standards and Isotope Labelled reference standards used in the Pharmaceutical industry, Food and Beverages, Phytochemistry, Environmental use, and Agricultural industry.
Pharmaffiliates is a research organization which is audited and accepted by US FDA along with many other accreditations like ISO Guide 34, ISO 9001:17025 and DSIR in their pocket.