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Documentos Principais

PHR1178

Supelco

Budesonide

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

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

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About This Item

Fórmula empírica (Notação de Hill):
C25H34O6
Número CAS:
Peso molecular:
430.53
Número CE:
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to BP 793
traceable to Ph. Eur. B1157300
traceable to USP 1078201

família API

budesonide

Certificado de análise (CofA)

current certificate can be downloaded

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

temperatura de armazenamento

2-8°C

cadeia de caracteres SMILES

[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

chave InChI

VOVIALXJUBGFJZ-KWVAZRHASA-N

Informações sobre genes

human ... NR3C1(2908)

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Descrição geral

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Budesonide is a nonsystemic glucocorticoid and an epimeric mixture, where both the epimers have similar anti-inflammatory activity. It is widely used in the treatment of Crohn′s disease.

Aplicação

Budesonide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance liquid chromatography technique.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Ações bioquímicas/fisiológicas

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.

Nota de análise

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Outras notas

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAB3750 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Danger

Classificações de perigo

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

Órgãos-alvo

Adrenal gland

Código de classe de armazenamento

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

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Development and validation of a high-performance liquid chromatographic method for the analysis of budesonide
Gupta M and Bhargava.NH
Journal of Pharmaceutical and Biomedical Analysis, 40(2), 423-428 (2006)
Topical Steroids in Gastroenterology and Hepatology (2004)
Koremu K Meja et al.
American journal of respiratory cell and molecular biology, 39(3), 312-323 (2008-04-19)
Oxidative stress as a result of cigarette smoking is an important etiologic factor in the pathogenesis of chronic obstructive pulmonary disease (COPD), a chronic steroid-insensitive inflammatory disease of the airways. Histone deacetylase-2 (HDAC2), a critical component of the corticosteroid anti-inflammatory
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
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

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