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PHR1398

Betamethasone

Name: Betamethasone
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(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

Empirical Formula (Hill Notation):

C₂₂H₂₉FO₅

CAS Number:

378-44-9

Molecular Weight:

392.46

EC Number:

206-825-4

MDL number:

MFCD00062969

UNSPSC Code:

41116107

PubChem Substance ID:

329823372

NACRES:

NA.24

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Sigma-Aldrich

B7005

Betamethasone

Supelco

PHR1399

Betamethasone Dipropionate

Supelco

PHR1526

Dexamethasone

B1000000

Betamethasone

USP

1066009

Betamethasone

Supelco

PHR1780

Betamethasone Valerate

Supelco

PHR1779

Betamethasone Acetate

Supelco

PHR3474

Betamethasone Valerate Related Compound A

Supelco

PHR1376

Loratadine

Supelco

PHR1014

Hydrocortisone

biological source

synthetic

Quality Level

300

grade

certified reference material
pharmaceutical secondary standard

Agency

BP
EP
USP
traceable to BP 575
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

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

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

InChI key

UREBDLICKHMUKA-DVTGEIKXSA-N

Gene Information

human ... NR3C1(2908)

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Related Categories

Analytical Reference Standards

Certified Reference Materials

Pharmacopeia & Metrological Institute Standards

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.

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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAA2174 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

Signal Word

Danger

Hazard Statements

H360FD,H373

Precautionary Statements

P202 - P260 - P280 - P308 + P313 - P405 - P501

Hazard Classifications

Repr. 1B - STOT RE 2

Target Organs

Liver,Kidney,Endocrine system

WGK

WGK 2

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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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)

A combination therapy protocol of plasmapheresis, intravenous immunoglobulins and betamethasone to treat anti-Ro/La-related congenital atrioventricular block. A case series and review of the literature.

Amelia Ruffatti et al.

Autoimmunity reviews, 12(7), 768-773 (2013-01-24)

The aim of this report was to evaluate the efficacy and safety of a combined treatment protocol used to treat 2nd and 3rd degree anti-Ro/La-related congenital atrioventricular block (CAVB). Six consecutive women diagnosed with 2nd degree (three cases) or 3rd

Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age.

M Gooderham et al.

The British journal of dermatology, 171(6), 1470-1477 (2014-07-02)

Plaque psoriasis has a relatively high prevalence in adolescence, resulting in a significant impact on quality of life, including social interactions. The primary objective was to assess the safety of once-daily application of fixed-combination calcipotriol plus betamethasone dipropionate gel in

Evaluation of strategies regarding management of imminent preterm delivery before 32 weeks of gestation: a regional cohort study among 1375 women in the Netherlands.

Merel Boesveld et al.

American journal of obstetrics and gynecology, 212(3), 348-348 (2014-12-03)

To evaluate the management of imminent preterm delivery with respect to prescription of antenatal corticosteroids (ACS) and referral to a tertiary center. A retrospective cohort study existing of 1 perinatal center and 9 referring hospitals. All women who received their

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Documents

Safety Information

Betamethasone

Pharmaceutical Secondary Standard; Certified Reference Material

Recommended Products

Properties

biological source

Quality Level

grade

Agency

vapor pressure

API family

CofA

packaging

storage condition

technique(s)

color

mp

solubility

density

application(s)

format

shipped in

storage temp.

SMILES string

InChI

InChI key

Gene Information

Related Categories

Description

General description

Application

Analysis Note

Other Notes

Footnote

Related Products

related product

Safety Information

Pictograms

Signal Word

Hazard Statements

Precautionary Statements

Hazard Classifications

Target Organs

WGK

Flash Point(F)

Flash Point(C)

Regulatory Information

Documentation

Certificates of Analysis (COA)

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