Itraconazole EP Impurity B

Name: Itraconazole EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-026251

About Itraconazole EP Impurity B

Itraconazole EP Impurity B is a pharmacopeial impurity of Itraconazole carrying the CAS registry number 854372-77-3. The compound has the formula C35H38Cl2N8O4, corresponding to a molecular weight of 705.6 g/mol. Alternative names: Itraconazole - Impurity B and (1,2,4-Triazol-4-yl) Itraconazole.

The product is provided 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 “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

Pharmaceutical QC and development laboratories use this impurity standard of Itraconazole to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Itraconazole EP Impurity B is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

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

Industries

Related to Itraconazole

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

Itraconazole impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Itraconazole EP Impurity B
Catalogue No.	VQ-026251
CAS Number	854372-77-3
IUPAC name	2-butan-2-yl-4-[4-[4-[4-[[(2S,4R)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-4-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
Molecular formula	C₃₅H₃₈Cl₂N₈O₄
Molecular weight	705.6 g/mol
Exact mass	704.2393
Grade	Reference Standard
HSN code	38229090
InChIKey	VRJGLVXBWFZNCZ-AVQIMAJZSA-N
SMILES	CCC(C)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OC[C@@H]5CO[C@@](O5)(CN6C=NN=C6)C7=C(C=C(C=C7)Cl)Cl
PubChem CID	72941921

Physical properties
Physical form	Solid
LogP (XLogP3)	5.1
H-bond donors / acceptors	0 / 9
TPSA	101 Å²
Synonyms	Itraconazole - Impurity B, (1,2,4-Triazol-4-yl) Itraconazole, Itraconazole specified impurity B, (+/-)-(1,2,4-Triazol-4-yl) itraconazole, Itraconazole Impurity 90 (Mixture of Diastereomers)

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H312Harmful in contact with skin
H315Causes skin irritation
H319Causes serious eye irritation
H332Harmful if inhaled

Precautionary statements: P261, P264, P264 + P265, P270, P271, P280, P301 + P317, P302 + P352, P304 + P340, P305 + P351 + P338, P317, P321, P330, P332 + P317, P337 + P317, P362 + P364, 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 Itraconazole EP Impurity B?

The CAS Registry Number of Itraconazole EP Impurity B is 854372-77-3. It is also known as Itraconazole - Impurity B, (1,2,4-Triazol-4-yl) Itraconazole, Itraconazole specified impurity B.

What is the molecular formula and molecular weight of Itraconazole EP Impurity B?

Itraconazole EP Impurity B has the molecular formula C35H38Cl2N8O4 and a molecular weight of 705.6 g/mol.

What is Itraconazole EP Impurity B used for?

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

We supply Itraconazole EP Impurity B 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 Itraconazole EP Impurity B?

Yes. Every lot of Itraconazole EP Impurity B 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 Itraconazole EP Impurity B be shipped internationally?

Yes. Itraconazole EP Impurity B 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.