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B1157300

Budesonide

European Pharmacopoeia (EP) Reference Standard

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Synonym(s):
16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione
Empirical Formula (Hill Notation):
C25H34O6
CAS Number:
51333-22-3
Molecular Weight:
430.53
MDL number:
MFCD00083259
UNSPSC Code:
41116107
PubChem Substance ID:
329773174
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

budesonide

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

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)

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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 EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

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.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

related product

Product No.
Description
Pricing

Y0001148

Budesonide for system suitability, European Pharmacopoeia (EP) Reference Standard

1078201

Budesonide, United States Pharmacopeia (USP) Reference Standard

1078289

Budesonide Related Compound L, United States Pharmacopeia (USP) Reference Standard

1078267

Budesonide Related Compound G, United States Pharmacopeia (USP) Reference Standard

1078245

Budesonide Related Compound E, United States Pharmacopeia (USP) Reference Standard

PHR1823

Budesonide Related Compound L, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1822

Budesonide Related Compound G, Pharmaceutical Secondary Standard; Certified Reference Material

BP793

Budesonide, British Pharmacopoeia (BP) Reference Standard

BP894

Budesonide impurity standard, British Pharmacopoeia (BP) Reference Standard

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H302,H317,H361d,H372,H412

Hazard Classifications

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

Target Organs

Adrenal gland

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Cumali Efe et al.
Autoimmunity reviews, 11(5), 330-334 (2011-10-18)
The aim of the present study was to assess the efficacy and tolerability of budesonide as an alternative first line treatment option for autoimmune hepatitis (AIH) and the overlap syndrome. A total of 18 AIH or overlap syndrome patients were
Marek Woynarowski et al.
The Journal of pediatrics, 163(5), 1347-1353 (2013-07-03)
To compare the effect of budesonide vs prednisone therapy both in combination with azathioprine in pediatric patients with autoimmune hepatitis (AIH). Forty-six patients with AIH (11 males and 35 females) aged 9-17 years were enrolled in a 6-month, prospective, double-blind
Nicole M Gentile et al.
The American journal of gastroenterology, 108(2), 256-259 (2013-01-09)
To evaluate the outcomes of corticosteroid-treated microscopic colitis (MC) in a population-based cohort, and to compare these outcomes in patients treated with prednisone or budesonide. A historical cohort study of Olmsted County, Minnesota residents diagnosed with collagenous or lymphocytic colitis
Maciej Kupczyk et al.
Thorax, 68(7), 611-618 (2013-04-09)
Objective measures are required that may be used as a proxy for exacerbations in asthma. The aim was to determine the sensitivity and specificity of electronic diary data to detect severe exacerbations (SEs) of asthma. A secondary aim was to
Mary E Sherlock et al.
The Cochrane database of systematic reviews, (10)(10), CD007698-CD007698 (2010-10-12)
Corticosteroids remain one of the most popular medication choices for the induction of remission in ulcerative colitis and Crohn's disease. While corticosteroids may improve symptoms, they do not always result in mucosal healing and have significant adverse effects. Steroids which
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