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PHR1178

Supelco

Budesonide

Pharmaceutical Secondary Standard; Certified Reference Material

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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
EC Number:
257-139-7
MDL number:
MFCD00083259
UNSPSC Code:
41116107
PubChem Substance ID:
329823190
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

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

API family

budesonide

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°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)

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General description

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.

Application

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.

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.

Analysis Note

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

Other Notes

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.

Footnote

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.

related product

Product No.
Description
Pricing

B1157300

Budesonide, European Pharmacopoeia (EP) Reference Standard

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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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)
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
Topical Steroids in Gastroenterology and Hepatology (2004)
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
Richard Beasley et al.
The Journal of allergy and clinical immunology, 133(1), 39-41 (2013-12-29)
The recommended treatment of mild asthma is regular maintenance inhaled corticosteroids (ICSs) with a short-acting β-agonist as a separate inhaler used when needed for symptom relief. However, the benefits of regular ICS use in actual clinical practice are limited by
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