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BP894

Budesonide impurity standard

British Pharmacopoeia (BP) Reference Standard

Synonym(s):

Budesonide, 16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione

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About This Item

Empirical Formula (Hill Notation):
C25H34O6
CAS Number:
Molecular Weight:
430.53
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
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grade

pharmaceutical primary standard

API family

budesonide

form

solid

shelf life

limited shelf life, expiry date on the label

manufacturer/tradename

BP

application(s)

pharmaceutical
pharmaceutical small molecule

format

mixture

storage temp.

−20°C

SMILES string

[H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1([H])[C@@H](O)C[C@@]4(C)[C@@]2([H])C[C@H]5OC(CCC)O[C@@]45C(=O)CO

InChI

1S/C25H34O6/c1-4-5-21-30-20-11-17-16-7-6-14-10-15(27)8-9-23(14,2)22(16)18(28)12-24(17,3)25(20,31-21)19(29)13-26/h8-10,16-18,20-22,26,28H,4-7,11-13H2,1-3H3/t16-,17-,18-,20+,21?,22+,23-,24-,25+/m0/s1

InChI key

VOVIALXJUBGFJZ-KWVAZRHASA-N

Gene Information

human ... NR3C1(2908)

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

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

Also used in monographs such as:
  • Budesonide Aqueous Nasal Spray
  • Biochem/physiol Actions

    Budesonide is a second generation glucocorticoid with low systemic absorption. It is used as an anti-inflammatory agent in the treatment of asthma, rhinitis, and inflammatory bowel disease. It inhibits the expression of chemokine mRNA and production of eotaxin and RANTES protein in primary human bronchial epithelial cells. Budesonide is currently in clinical trials for the prevention of lung cancer. It shows inhibitory effects on benzo[a]pyrene-induced carcinogenesis of the lung in mice.
    Second generation glucocorticoid with low systemic absorption; anti-inflammatory agent; inhibits the expression of chemokine mRNA and production of eotaxin and RANTES protein.

    Packaging

    Unit quantity: 10 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
    BP793BP8111078201
    Budesonide British Pharmacopoeia (BP) Reference Standard

    BP793

    Budesonide

    grade

    pharmaceutical primary standard

    grade

    pharmaceutical primary standard

    grade

    pharmaceutical primary standard

    grade

    pharmaceutical primary standard

    manufacturer/tradename

    BP

    manufacturer/tradename

    BP

    manufacturer/tradename

    BP

    manufacturer/tradename

    USP

    application(s)

    pharmaceutical
    pharmaceutical small molecule

    application(s)

    pharmaceutical
    pharmaceutical small molecule

    application(s)

    pharmaceutical
    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

    limited shelf life, expiry date on the label

    shelf life

    -

    format

    mixture

    format

    neat

    format

    mixture

    format

    neat

    form

    solid

    form

    solid

    form

    solid

    form

    -


    pictograms

    Health hazardExclamation mark

    signalword

    Danger

    Hazard Classifications

    Acute Tox. 4 Oral - Aquatic Chronic 3 - Repr. 2 - Skin Sens. 1 - STOT RE 1 Inhalation

    target_organs

    Adrenal gland

    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. To whom it may concern, what do you mean exactly for Impurity standard? Is there any isotope present in the molecule, like a C-13 substitution for budesonide?

      1 answer
      1. This is a compendial impurity standard product of the British Pharmacopoeia. This material is not isotopically labeled and is intended for use as a representative standard of the impurities known to be present in budesonide. A chromatogram of the current lot lists Budesonide epimers A & B, as well as Impurity D epimers 1 & 2. Please see the link below to access the supplier leaflet containing additional data:
        https://www.pharmacopoeia.com/shop/products/1000014614

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