Quetiapine EP Impurity H

About Quetiapine EP Impurity H

Quetiapine EP Impurity H is a pharmacopeial impurity of Quetiapine carrying the CAS registry number 1076199-40-0. Its molecular formula is C21H25N3O3S and its molecular weight is 399.5 g/mol. Its systematic (IUPAC) name is 2-[2-(4-benzo[b][1,4]benzothiazepin-6-yl-1-oxidopiperazin-1-ium-1-yl)ethoxy]ethanol. Common synonyms include Quetiapine N-Oxide and Quetiapine Related Compound H (USP).

The product is provided as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Quetiapine to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. It is used across pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Quetiapine

View every impurity, metabolite and intermediate we list for Quetiapine.

Quetiapine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Quetiapine EP Impurity H
Catalogue No.	VQ-006617
CAS Number	1076199-40-0
IUPAC name	2-[2-(4-benzo[b][1,4]benzothiazepin-6-yl-1-oxidopiperazin-1-ium-1-yl)ethoxy]ethanol
Molecular formula	C₂₁H₂₅N₃O₃S
Molecular weight	399.5 g/mol
Exact mass	399.1617
Grade	Reference Standard
HSN code	38229090
InChIKey	VVBXDYFGQNNTDS-UHFFFAOYSA-N
SMILES	C1C[N+](CCN1C2=NC3=CC=CC=C3SC4=CC=CC=C42)(CCOCCO)[O-]
PubChem CID	29986777

Physical properties
Physical form	Solid
LogP (XLogP3)	1.6
H-bond donors / acceptors	1 / 5
TPSA	88.4 Å²
Synonyms	2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol N-Oxide, Quetiapine N-Oxide, Quetiapine Related Compound H (USP), 2-(2-(4-Dibenzo(b,f)(1,4)thiazepin-11-yl-1-oxido-1-piperazinyl)ethoxy)ethanol, 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-oxido-1-piperazinyl)ethoxy]ethanol, Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-oxido-1-piperazinyl)ethoxy)-, Ethanol, 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-oxido-1-piperazinyl)ethoxy]-, Quetiapine fumarate impurity H, Quetiapine impurity H, 2-[2-(4-benzo[b][1,4]benzothiazepin-6-yl-1-oxido-piperazin-1-ium-1-yl)ethoxy]ethanol, Ethanol,2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-oxido-1-piperazinyl)ethoxy]-

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed

Precautionary statements: P264, P270, P301 + P317, P330, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Quetiapine EP Impurity H?

The CAS Registry Number of Quetiapine EP Impurity H is 1076199-40-0. It is also known as 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol N-Oxide, Quetiapine N-Oxide, Quetiapine Related Compound H (USP).

What is the molecular formula and molecular weight of Quetiapine EP Impurity H?

Quetiapine EP Impurity H has the molecular formula C21H25N3O3S and a molecular weight of 399.5 g/mol. Its IUPAC name is 2-[2-(4-benzo[b][1,4]benzothiazepin-6-yl-1-oxidopiperazin-1-ium-1-yl)ethoxy]ethanol.

What is Quetiapine EP Impurity H used for?

Quetiapine EP Impurity H is supplied as a characterised reference material related to Quetiapine. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Quetiapine EP Impurity H can I order?

We supply Quetiapine EP Impurity H in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Quetiapine EP Impurity H?

Yes. Every lot of Quetiapine EP Impurity H is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Quetiapine EP Impurity H be shipped internationally?

Yes. Quetiapine EP Impurity H is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.