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Pharmacopeial Impurities (EP / USP / BP)

Ketoconazole EP Impurity D

Reference StandardAvailable on request

Buy Ketoconazole EP Impurity D (CAS 67914-61-8) from Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-021926.

Pack sizes
Ketoconazole EP Impurity D chemical structure
CAS number67914-61-8
FormulaC24H26Cl2N4O3
Molar mass489.4 g/mol
Physical formSolid
HS code38229090
InChIKeyLOUXSEJZCPKWAX-URXFXBBRSA-N
IUPAC name1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine

About Ketoconazole EP Impurity D

Analytical teams working on Ketoconazole use Ketoconazole EP Impurity D as a qualified comparison standard. Identity at a glance (Reference Standard): CAS 67914-61-8, formula C24H26Cl2N4O3 and molar mass 489.4 g/mol. It is handled as a solid.

Use cases we see most often

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

Handling and storage

Classified under GHS with signal word Danger and hazard statements H301, H341, H373 and H410. Read the SDS before first use.

Order it in 10 mg, 25 mg, 50 mg and 100 mg packs or ask for a bulk quotation. Every shipment includes a certificate of analysis with characterisation data. Request pricing online and we confirm availability, documentation and freight to your country.

Reference standards for Ketoconazole

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

Ketoconazole 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 Ketoconazole EP Impurity D
Product nameKetoconazole EP Impurity D
Catalogue numberZX-021926
CAS number67914-61-8
IUPAC name1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
Molecular formulaC24H26Cl2N4O3
Molar mass489.4 g/mol
Exact mass488.1382
GradeReference Standard
Physical formSolid
XLogP34.4
H-bond donors / acceptors1 / 6
Topological polar surface area60.8 Ų
HS code38229090
InChIKeyLOUXSEJZCPKWAX-URXFXBBRSA-N
SMILESC1CN(CCN1)C2=CC=C(C=C2)OC[C@H]3CO[C@](O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
PubChem CID12854716
SynonymsKetoconazole Impurity D, N-desacetyl Ketoconazole, Ketoconazole - Impurity D, de-N-acetylketoconazole, Deacetyl Ketoconazole, N-Deacetylketoconazole, N-Desacetyl Ketonazole

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

Safety and GHS hazards

GHS06 Acute toxicity
Acute toxicity
GHS08 Health hazard
Health hazard
GHS09 Hazardous to the environment
Hazardous to the environment

Signal word Danger

  • 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 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 Ketoconazole EP Impurity D
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 Ketoconazole EP Impurity D

Which CAS number identifies Ketoconazole EP Impurity D?
Ketoconazole EP Impurity D is registered under CAS 67914-61-8. You may also see it listed as Ketoconazole Impurity D, N-desacetyl Ketoconazole, Ketoconazole - Impurity D. Our catalogue number for this item is ZX-021926.
What are the formula and molar mass of Ketoconazole EP Impurity D?
For Ketoconazole EP Impurity D, its formula is C24H26Cl2N4O3 and its molar mass is 489.4 g/mol. The systematic (IUPAC) name is 1-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine. InChIKey LOUXSEJZCPKWAX-URXFXBBRSA-N lets you match it in any structure database.
How is Ketoconazole EP Impurity D used in pharmaceutical QC?
Ketoconazole EP Impurity D is a characterised reference material linked to Ketoconazole. 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 Ketoconazole EP Impurity D?
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 Ketoconazole EP Impurity D?
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 Ketoconazole EP Impurity D to my country?
Yes. Because Ketoconazole EP Impurity D 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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