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Key Documents

PHR1398

Supelco

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Betamethasone, 9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione, 9α-Fluoro-16β-methyl-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione, 9α-Fluoro-16β-methylprednisolone

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About This Item

Formula empirica (notazione di Hill):
C22H29FO5
Numero CAS:
Peso molecolare:
392.46
Numero CE:
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Origine biologica

synthetic

Livello qualitativo

Grado

certified reference material
pharmaceutical secondary standard

agenzia

BP
EP
USP
traceable to BP 575
traceable to Ph. Eur. B1000000
traceable to USP 1066009

Tensione di vapore

<0.0000001 kPa ( 25 °C)

Famiglia di API

betamethasone

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

Condizioni di stoccaggio

protect from light (20 mm aluminium crimp seal for unused portion)

tecniche

HPLC: suitable
gas chromatography (GC): suitable

Colore

white to light yellow

Punto di fusione

235-237 °C (lit.)

Solubilità

acetone: sparingly soluble
chloroform: very slightly soluble
ethanol: sparingly soluble
ether: very slightly soluble
methanol: sparingly soluble
water: insoluble

Densità

0.305 g/cm3 at 25 °C (77°F)

applicazioni

pharmaceutical (small molecule)

Formato

neat

Condizioni di spedizione

ambient

Temperatura di conservazione

2-30°C

Stringa SMILE

[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]3(F)[C@@]2([H])CCC4=CC(=O)C=C[C@]34C

InChI

1S/C22H29FO5/c1-12-8-16-15-5-4-13-9-14(25)6-7-19(13,2)21(15,23)17(26)10-20(16,3)22(12,28)18(27)11-24/h6-7,9,12,15-17,24,26,28H,4-5,8,10-11H2,1-3H3/t12-,15-,16-,17-,19-,20-,21-,22-/m0/s1
UREBDLICKHMUKA-DVTGEIKXSA-N

Informazioni sul gene

human ... NR3C1(2908)

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Descrizione generale

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.
Betamethasone belongs to the corticosteriod family of active pharmaceutical ingredients (APIs). It exhibits anti-inflammatory activity and hence is used in the manufacture of various finished pharmaceutical products and is also employed as a starting material to manufacture other APIs that are related to this steroid family.

Applicazioni

Betamethasone may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations by using micellar liquid chromatography technique and reversed-phase 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.

Risultati analitici

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

Altre note

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 a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAA2174 in the slot below. This is an example certificate only and may not be the lot that you receive.

Prodotti correlati

N° Catalogo
Descrizione
Determinazione del prezzo

Pittogrammi

Health hazard

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

Repr. 1B - STOT RE 2

Organi bersaglio

Liver,Kidney,Endocrine system

Codice della classe di stoccaggio

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

Classe di pericolosità dell'acqua (WGK)

WGK 2

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Simultaneous determination of dexamethasone and betamethasone in pharmaceuticals by reversed-phase HPLC
Pena-Garcia-Brioles D, et al.
Chromatographia, 39(9), 539-542 (1994)
Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds
Fu Q, et al.
Journal of Pharmaceutical and Biomedical Analysis, 51(3), 617-625 (2010)
Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone
Xiong Y, et al.
Journal of Pharmaceutical and Biomedical Analysis, 49(3), 646-654 (2009)
Method development for betamethasone and dexamethasone by micellar liquid chromatography using cetyl trimethyl ammonium bromide and validation in tablets: Application to cocktails
Pena-Garcia-Brioles D, et al.
Journal of Pharmaceutical and Biomedical Analysis, 36(1), 65-71 (2004)
Brian W Blakley et al.
The Laryngoscope, 124(5), 1209-1213 (2013-10-22)
To determine whether betamethasone (BM) reduces the cochlear toxicity of otic gentamicin (GM) if given together. Controlled animal study. Thirty-four mice were assigned at random to receive intratympanic injections of either 0.1 % BM (11 mice), 0.3% GM (13 mice)

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