Risperidone EP Impurity H

About Risperidone EP Impurity H

Risperidone EP Impurity H is a pharmacopeial impurity of Risperidone carrying the CAS registry number 158697-67-7 with a typical assay of 37.7%. With the molecular formula C23H27F2N3O2, it has a molar mass of 415.5 g/mol. Its systematic (IUPAC) name is 3-[2-[4-(2,4-difluorobenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one. Alternative names: Risperidone Difluoroketone and 2,4-Difluorobenzoyl Risperidone Impurity.

It is supplied as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

Pharmaceutical QC and development laboratories use this impurity standard of Risperidone to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Risperidone EP Impurity H is dispatched with a Certificate of Analysis (COA) to destinations worldwide. This item is currently in stock for prompt dispatch.

Typical applications

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

Industries

Related to Risperidone

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

Risperidone impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Risperidone EP Impurity H
Catalogue No.	VQ-006643
CAS Number	158697-67-7
IUPAC name	3-[2-[4-(2,4-difluorobenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
Molecular formula	C₂₃H₂₇F₂N₃O₂
Molecular weight	415.5 g/mol
Exact mass	415.2071
Grade	Reference Standard
Purity / assay	37.7%
HSN code	38229090
InChIKey	VVQWCIXBRCHDBW-UHFFFAOYSA-N
SMILES	CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C(=O)C4=C(C=C(C=C4)F)F
PubChem CID	29941101

Physical properties
Physical form	Solid
LogP (XLogP3)	2.6
H-bond donors / acceptors	0 / 6
TPSA	53 Å²

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 Risperidone EP Impurity H?

The CAS Registry Number of Risperidone EP Impurity H is 158697-67-7. It is also known as Risperidone Difluoroketone, 2,4-Difluorobenzoyl Risperidone Impurity, DES(6-fluoro-1,2-benzoxazole)-2,4-difluorobenzoyl risperidone.

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

Risperidone EP Impurity H has the molecular formula C23H27F2N3O2 and a molecular weight of 415.5 g/mol. Its IUPAC name is 3-[2-[4-(2,4-difluorobenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one.

What is Risperidone EP Impurity H used for?

Risperidone EP Impurity H is supplied as a characterised reference material related to Risperidone. 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 Risperidone EP Impurity H can I order?

We supply Risperidone EP Impurity H in Reference Standard (37.7%) grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg, 500 mg packs. Larger bulk quantities and custom packing are quoted on request.

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

Yes. Every lot of Risperidone 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 Risperidone EP Impurity H be shipped internationally?

Yes. Risperidone 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.