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Merck
CN

PHR1399

Betamethasone Dipropionate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):
C28H37FO7
CAS Number:
5593-20-4
Molecular Weight:
504.59
NACRES:
NA.24
PubChem Substance ID:
329823373
UNSPSC Code:
41116107
EC Number:
227-005-2
MDL number:
MFCD00133140

Key Documents

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Product Name

Betamethasone Dipropionate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

UOCNBCVPZWLUKX-HOBFILNXSA-N

InChI

1S/C27H34ClFO7/c1-5-22(33)35-14-21(32)27(36-23(34)13-28)15(2)10-19-18-7-6-16-11-17(30)8-9-24(16,3)26(18,29)20(31)12-25(19,27)4/h8-9,11,15,18-20,31H,5-7,10,12-14H2,1-4H3/t15-,18-,19-,20-,24-,25-,26?,27-/m0/s1

SMILES string

[H][C@@]12C[C@H](C)[C@](OC(=O)CCl)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)C3(F)[C@@]2([H])CCC4=CC(=O)C=C[C@]34C

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. B1040000
traceable to USP 1067704

API family

betamethasone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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Other Notes

To see an example of a Certificate of Analysis for this material enter LRAA2175 in the slot below. This is an example certificate only and may not be the lot that you receive.
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.

Analysis Note

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

Application

Betamethasone dipropionate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
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

Betamethasone 17,21-dipropionate is a glucocorticoid with anti-inflammatory and immunosuppressive activity.

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 dipropionate is a synthetic glucocorticoid, used as an anti-inflammatory agent to treat different skin disorders.

pictograms

Health hazard
GHS08

signalword

Danger

Hazard Classifications

Repr. 1B - STOT RE 2

target_organs

Liver,Kidney,Endocrine system

Storage Class

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

Regulatory Information

涉药品监管产品
This item has

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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RP-HPLC method for simultaneous determination of butenafine hydrochloride and betamethasone dipropionate in a cream formulation.
Bhosale SD and Rajput SJ
Journal of AOAC (Association of Official Analytical Chemists) International, 94(1), 106-109 (2011)
Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion?
Shou M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 50(3), 356-361 (2009)
A validated simultaneous RP-HPLC method for determination of betamethasone dipropionate and tolnaftate in combined semisolid formulation.
Saha CN and Bhattacharya S
International Journal of ChemTech Research, 1(3), 671-674 (2009)
Sally A Helmy et al.
Therapeutic drug monitoring, 36(1), 100-107 (2013-11-26)
Diflunisal, naproxen, ketoprofen, etodolac, mefenamic acid, rofecoxib, and celecoxib are nonsteroidal anti-inflammatory drugs, which have analgesics, antipyretics, and anti-inflammatory activities. The aim of this work was to develop and validate a simple assay that could be implemented in most laboratories
Lawrence F Eichenfield et al.
Pediatric dermatology, 32(1), 28-35 (2014-11-22)
The objective of this study was to assess the safety and efficacy of the fixed combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% topical suspension in adolescents with extensive scalp psoriasis. In this phase II, open-label, 8-week study, adolescents with psoriasis
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