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PHR1618

Supelco

Miconazole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Miconazole, (±)-1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
Empirical Formula (Hill Notation):
C18H14Cl4N2O
CAS Number:
Molecular Weight:
416.13
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur M1880000
traceable to USP 1443409

storage temp.

2-30°C

InChI

1S/C18H14Cl4N2O/c19-13-2-1-12(16(21)7-13)10-25-18(9-24-6-5-23-11-24)15-4-3-14(20)8-17(15)22/h1-8,11,18H,9-10H2

InChI key

BYBLEWFAAKGYCD-UHFFFAOYSA-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. Miconazole is an antimycotic-imidazole derivative compound which is utilized for the management of topical fungal infections. It is typically effective against dermatophytes and Candida albicans, and also many Gram-positive germens.

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.
Miconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations, and bulk and cream formulations by chromatography and spectrophotometry techniques.

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 LRAB5528 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 4

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Analysis of miconazole and econazole in pharmaceutical formulations by derivative UV spectroscopy and liquid chromatography (HPLC)
Cavrini V, et al.
Journal of Pharmaceutical and Biomedical Analysis, 7(12), 1535-1543 (1989)
Miconazole
USP42-NF37
United States Pharmacopeia/National Formulary, 41(5), 2909-2909 (2013)
Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations.
De Zan MM, et al.
Talanta, 79(3), 762-767 (2009)
Determination of miconazole in pharmaceutical creams using internal standard and second derivative spectrophotometry.
Wrobel K, et al.
Journal of Pharmaceutical and Biomedical Analysis, 20(1-2), 99-105 (1999)

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