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BP1170

Ketoconazole impurity standard

British Pharmacopoeia (BP) Reference Standard

Synonym(s):

Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine

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Size/SKUAvailabilityPrice
25 mg
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£206.00

About This Item

Empirical Formula (Hill Notation):
C26H28Cl2N4O4
CAS Number:
Molecular Weight:
531.43
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:

£206.00


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grade

pharmaceutical primary standard

agency

BP

API family

ketoconazole

form

powder

shelf life

limited shelf life, expiry date on the label

manufacturer/tradename

BP

application(s)

pharmaceutical
pharmaceutical small molecule

format

mixture

storage temp.

2-8°C

SMILES string

CC(=O)N1CCN(CC1)c2ccc(OC[C@H]3CO[C@@](Cn4ccnc4)(O3)c5ccc(Cl)cc5Cl)cc2

InChI

1S/C26H28Cl2N4O4/c1-19(33)31-10-12-32(13-11-31)21-3-5-22(6-4-21)34-15-23-16-35-26(36-23,17-30-9-8-29-18-30)24-7-2-20(27)14-25(24)28/h2-9,14,18,23H,10-13,15-17H2,1H3/t23-,26-/m0/s1

InChI key

XMAYWYJOQHXEEK-OZXSUGGESA-N

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

CYP3A4 inhibitor
Ketoconazole impurity standard, intended for use in laboratory tests only as specifically prescribed in the British Pharmacopoeia.

Also used in monographs such as:
  • Ketoconazole Shampoo
  • Ketoconazole Cream
  • Biochem/physiol Actions

    Antifungal agent

    Packaging

    Unit quantity: 25 mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity please visit British Pharmacopoeia

    Other Notes

    Sales restrictions may apply.

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    This Item
    BP1169K0600000PHR1385
    description

    British Pharmacopoeia (BP) Reference Standard

    description

    British Pharmacopoeia (BP) Reference Standard

    description

    European Pharmacopoeia (EP) Reference Standard

    description

    Pharmaceutical Secondary Standard; Certified Reference Material

    grade

    pharmaceutical primary standard

    grade

    pharmaceutical primary standard

    grade

    pharmaceutical primary standard

    grade

    certified reference material, pharmaceutical secondary standard

    manufacturer/tradename

    BP

    manufacturer/tradename

    BP

    manufacturer/tradename

    EDQM

    manufacturer/tradename

    -

    format

    mixture

    format

    neat

    format

    neat

    format

    neat

    form

    powder

    form

    powder

    form

    -

    form

    -

    application(s)

    pharmaceutical
    pharmaceutical small molecule

    application(s)

    pharmaceutical
    pharmaceutical small molecule

    application(s)

    pharmaceutical (small molecule)

    application(s)

    pharmaceutical (small molecule)

    shelf life

    limited shelf life, expiry date on the label

    shelf life

    limited shelf life, expiry date on the label

    shelf life

    -

    shelf life

    -


    signalword

    Danger

    Hazard Classifications

    Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2

    Storage Class

    6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

    wgk

    WGK 3

    flash_point_f

    Not applicable

    flash_point_c

    Not applicable



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    Questions

    1. As per BP23 , ketoconazole shampoo monograph there shall be 4 impurity peak but as per impurity COA shows only 3 peak..

      1 answer
      1. The BP1170, Ketoconazole impurity standard, is a product of the British Pharmacopoeia. The chromatogram of the Ketoconazole Shampoo Monograph identifies 3 impurity peaks - 1, 3, and D - as well as the kotoconazole major peak. For results outside of those reported in the leaflet, please contact the British Pharacopoeia. A link to the leaflet (see page 2) showing the chromatogram is below:
        https://www.pharmacopoeia.com/Catalogue/Preview?uri=%2Fcontent%2Ffile%2Fproducts%2Fleaflets%2FBPCRS-Leaflet_Cat-1170_BPCRS3884_1.pdf

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