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PHR1399

Supelco

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
Empirical Formula (Hill Notation):
C28H37FO7
CAS Number:
Molecular Weight:
504.59
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur B1040000
traceable to USP 1067704

storage temp.

2-30°C

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

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

InChI key

UOCNBCVPZWLUKX-HOBFILNXSA-N

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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.

Application

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

Biochem/physiol Actions

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

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 LRAA2175 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Repr. 1B - STOT RE 2

Storage Class Code

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

Certificate of Analysis

Certificate of Origin

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)
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)
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)
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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