Ketoconazole EP Impurity D

About Ketoconazole EP Impurity D

Ketoconazole EP Impurity D is a pharmacopeial impurity of Ketoconazole carrying the CAS registry number 67914-61-8. Formula C24H26Cl2N4O3, molecular weight 489.4 g/mol. The IUPAC name is 1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine. Alternative names: Ketoconazole Impurity D and N-desacetyl Ketoconazole.

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. The GHS classification uses the signal word “Danger”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Ketoconazole 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.

We offer Ketoconazole EP Impurity D in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide.

Typical applications

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

Industries

Related to Ketoconazole

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

Ketoconazole impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Ketoconazole EP Impurity D
Catalogue No.	VQ-022900
CAS Number	67914-61-8
IUPAC name	1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
Molecular formula	C₂₄H₂₆Cl₂N₄O₃
Molecular weight	489.4 g/mol
Exact mass	488.1382
Grade	Reference Standard
HSN code	38229090
InChIKey	LOUXSEJZCPKWAX-URXFXBBRSA-N
SMILES	C1CN(CCN1)C2=CC=C(C=C2)OC[C@H]3CO[C@](O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
PubChem CID	12854716

Physical properties
Physical form	Solid
LogP (XLogP3)	4.4
H-bond donors / acceptors	1 / 6
TPSA	60.8 Å²
Synonyms	Ketoconazole Impurity D, N-desacetyl Ketoconazole, Ketoconazole - Impurity D, de-N-acetylketoconazole, Deacetyl Ketoconazole, N-Deacetylketoconazole, N-Desacetyl Ketonazole

Safety & hazard information (GHS)

Toxic

Health hazard

Environmental hazard

Signal word: Danger

Hazard statements

H301Toxic if swallowed
H341Suspected of causing genetic defects
H373May causes damage to organs through prolonged or repeated exposure
H410Very toxic to aquatic life with long lasting effects
H411Toxic to aquatic life with long lasting effects

Precautionary statements: P203, P260, P264, P270, P273, P280, P301 + P316, P318, P319, P321, P330, P391, P405, 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 Ketoconazole EP Impurity D?

The CAS Registry Number of Ketoconazole EP Impurity D is 67914-61-8. It is also known as Ketoconazole Impurity D, N-desacetyl Ketoconazole, Ketoconazole - Impurity D.

What is the molecular formula and molecular weight of Ketoconazole EP Impurity D?

Ketoconazole EP Impurity D has the molecular formula C24H26Cl2N4O3 and a molecular weight of 489.4 g/mol. Its IUPAC name is 1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.

What is Ketoconazole EP Impurity D used for?

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

We supply Ketoconazole EP Impurity D 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 Ketoconazole EP Impurity D?

Yes. Every lot of Ketoconazole EP Impurity D 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 Ketoconazole EP Impurity D be shipped internationally?

Yes. Ketoconazole EP Impurity D 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.