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Merck
CN

PHR1398

倍他米松

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

倍他米松, 9α-氟-11β,17α,21-三羟基-16β-甲基孕甾-1,4-二烯-3,20-二酮, 9α-氟-16β-甲基-11β,17α,21-三羟基-1,4-孕甾二烯-3,20-二酮, 9α-氟-16β-甲基泼尼松龙

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关于此项目

经验公式（希尔记法）:
C22H29FO5
化学文摘社编号:
378-44-9
分子量:
392.46
NACRES:
NA.24
PubChem Substance ID:
329823372
UNSPSC Code:
41116107
EC Number:
206-825-4
MDL number:
MFCD00062969

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产品名称

倍他米松, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

UREBDLICKHMUKA-DVTGEIKXSA-N

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

SMILES string

[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

biological source

synthetic

grade

certified reference material
pharmaceutical secondary standard

agency

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

vapor pressure

<0.0000001 kPa ( 25 °C)

API family

betamethasone

CofA

current certificate can be downloaded

packaging

pkg of 1 g

storage condition

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

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

color

white to light yellow

mp

235-237 °C (lit.)

solubility

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

density

0.305 g/cm3 at 25 °C (77°F)

application(s)

pharmaceutical (small molecule)

format

neat

shipped in

ambient

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... NR3C1(2908)

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相关类别

Analysis Note

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

Application

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.

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.
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.

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.
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.

pictograms

Health hazard
GHS08

signalword

Danger

Hazard Classifications

Repr. 1B - STOT RE 2

target_organs

Liver,Kidney,Endocrine system

存储类别

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

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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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 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)
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)
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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