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PHR1618

Miconazole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Miconazole, (±)-1-[2-(2,4-Dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole

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R 2,434.32

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About This Item

Empirical Formula (Hill Notation):
C18H14Cl4N2O
CAS Number:
22916-47-8
Molecular Weight:
416.13
UNSPSC Code:
41116107
NACRES:
NA.24

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Product Name

Miconazole, Pharmaceutical Secondary Standard; Certified Reference Material

SMILES string

Clc1c(ccc(c1)Cl)C(OCc3c(cc(cc3)Cl)Cl)C[n]2cncc2

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

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

300

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Show Differences

1 of 4

This Item
PHR1163M1880000PHR1385
Miconazole Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1618

Miconazole

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

Supelco

PHR1163

(±)-Miconazole nitrate salt

vibrant-m

M1880000

Miconazole

Ketoconazole Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1385

Ketoconazole

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

format

neat

format

neat

format

neat

format

neat

Quality Level

300

Quality Level

300

Quality Level

-

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

certified reference material, pharmaceutical secondary standard

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

-

storage temp.

2-30°C

Analysis Note

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

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[1][2][3] and spectrophotometry[2][4] 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.

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.[2][3]

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.
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

signalword

Warning

hcodes

H302,H413

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 4

Storage Class

11 - Combustible Solids

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)
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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