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Pharmacopeial Impurities (EP / USP / BP)

Itraconazole EP Impurity B

Reference StandardAvailable on request

Buy Itraconazole EP Impurity B (CAS 854372-77-3) from Zemixal: C35H38Cl2N8O4, COA and SDS with every lot, worldwide shipping.

Pack sizes
Itraconazole EP Impurity B chemical structure
CAS number854372-77-3
FormulaC35H38Cl2N8O4
Molar mass705.6 g/mol
Physical formSolid
HS code38229090
InChIKeyVRJGLVXBWFZNCZ-AVQIMAJZSA-N
IUPAC name2-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

About Itraconazole EP Impurity B

Zemixal lists Itraconazole EP Impurity B for laboratories that identify, quantify or control Itraconazole and its related substances. Key data (Reference Standard): CAS 854372-77-3, formula C35H38Cl2N8O4 and molar mass 705.6 g/mol. It is handled as a solid.

Where it is used

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

Safe handling

It carries the GHS signal word Warning (H302, H312, H315 and H319), so wear gloves and eye protection and work with good ventilation.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. Each lot travels with a certificate of analysis with characterisation data. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Itraconazole

See every impurity, metabolite and related compound we list for this API.

Itraconazole standards

Typical uses

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

Applications

Pharmaceutical Manufacturing and QCResearch Labs and Universities

Grade guides

Ph. Eur. Grade (European Pharmacopoeia)

Specifications and identifiers

Specifications of Itraconazole EP Impurity B
Product nameItraconazole EP Impurity B
Catalogue numberZX-025193
CAS number854372-77-3
IUPAC name2-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 formulaC35H38Cl2N8O4
Molar mass705.6 g/mol
Exact mass704.2393
GradeReference Standard
Physical formSolid
XLogP35.1
H-bond donors / acceptors0 / 9
Topological polar surface area101 Ų
HS code38229090
InChIKeyVRJGLVXBWFZNCZ-AVQIMAJZSA-N
SMILESCCC(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 CID72941921
SynonymsItraconazole - 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)

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

GHS07 Irritant or harmful
Irritant or harmful

Signal word Warning

  • 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 summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Itraconazole EP Impurity B
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Itraconazole EP Impurity B

Which CAS number identifies Itraconazole EP Impurity B?
Itraconazole EP Impurity B is registered under CAS 854372-77-3. You may also see it listed as Itraconazole - Impurity B, (1,2,4-Triazol-4-yl) Itraconazole, Itraconazole specified impurity B. Our catalogue number for this item is ZX-025193.
What are the formula and molar mass of Itraconazole EP Impurity B?
For Itraconazole EP Impurity B, its formula is C35H38Cl2N8O4 and its molar mass is 705.6 g/mol. InChIKey VRJGLVXBWFZNCZ-AVQIMAJZSA-N lets you match it in any structure database.
How is Itraconazole EP Impurity B used in pharmaceutical QC?
Itraconazole EP Impurity B is a characterised reference material linked to Itraconazole. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Itraconazole EP Impurity B?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Itraconazole EP Impurity B?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Itraconazole EP Impurity B to my country?
Yes. Because Itraconazole EP Impurity B is classed as hazardous, it travels in UN-approved packaging as dangerous goods under IATA or IMDG rules, with the export paperwork your broker needs.

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