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PHR1618

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Miconazole

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Miconazole, (±)-1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
Empirical Formula (Hill Notation):
C18H14Cl4N2O
CAS Number:
22916-47-8
Molecular Weight:
416.13
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. M1880000
traceable to USP 1443409

API family

miconazole

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

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

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.
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 LRAB5528 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

PHR1163

(±)-Miconazole nitrate salt, Pharmaceutical Secondary Standard; Certified Reference Material

1443500

Miconazole nitrate, United States Pharmacopeia (USP) Reference Standard

M1900000

Miconazole nitrate, European Pharmacopoeia (EP) Reference Standard

M1880000

Miconazole, European Pharmacopoeia (EP) Reference Standard

Y0001620

2,4-Dichlorobenzyl alcohol, European Pharmacopoeia (EP) Reference Standard

1443409

Miconazole, United States Pharmacopeia (USP) Reference Standard

1443431

Miconazole Related Compound C, United States Pharmacopeia (USP) Reference Standard

1443464

Miconazole Related Compound F, United States Pharmacopeia (USP) Reference Standard

1443497

Miconazole Related Compound I, United States Pharmacopeia (USP) Reference Standard

BP253

Miconazole nitrate, British Pharmacopoeia (BP) Reference Standard

BP884

Miconazole impurity A, British Pharmacopoeia (BP) Reference Standard

PHR9002

1-[(2RS)-2-(Benzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazolium nitrate, certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302,H413

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 4

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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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)
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)
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)

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