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Documentos Principais

PHR1398

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Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

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

Fórmula empírica (Notação de Hill):
C22H29FO5
Número CAS:
Peso molecular:
392.46
Número CE:
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

fonte biológica

synthetic

Nível de qualidade

grau

certified reference material
pharmaceutical secondary standard

Agency

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

pressão de vapor

<0.0000001 kPa ( 25 °C)

família API

betamethasone

Certificado de análise (CofA)

current certificate can be downloaded

embalagem

pkg of 1 g

condição de armazenamento

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

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

cor

white to light yellow

pf

235-237 °C (lit.)

solubilidade

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

densidade

0.305 g/cm3 at 25 °C (77°F)

aplicação(ões)

pharmaceutical (small molecule)

Formato

neat

Condições de expedição

ambient

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

[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

chave InChI

UREBDLICKHMUKA-DVTGEIKXSA-N

Informações sobre genes

human ... NR3C1(2908)

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Categorias relacionadas

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.
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.

Aplicação

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.

Nota de análise

These secondary standards offer multi-traceability to the USP, EP 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 LRAA2174 in the slot below. This is an example certificate only and may not be the lot that you receive.

produto relacionado

Nº do produto
Descrição
Preços

Pictogramas

Health hazard

Palavra indicadora

Danger

Frases de perigo

Classificações de perigo

Repr. 1B - STOT RE 2

Órgãos-alvo

Liver,Kidney,Endocrine system

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 2

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°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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