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PHR1385

Supelco

Ketoconazole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonim(y):

Ketoconazole, (±)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine

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About This Item

Wzór empiryczny (zapis Hilla):
C26H28Cl2N4O4
Numer CAS:
65277-42-1
Masa cząsteczkowa:
531.43
Numer WE:
265-667-4
Numer MDL:
MFCD00058579
Kod UNSPSC:
41116107
Identyfikator substancji w PubChem:
329823362
NACRES:
NA.24
Produkt PHR1385 nie jest obecnie dostępny w sprzedaży w Twoim kraju Skontaktuj się z zespołem ds. pomocy technicznej

klasa czystości

certified reference material
pharmaceutical secondary standard

Poziom jakości

300

agency

traceable to Ph. Eur. K0600000
traceable to USP 1356508

rodzina API

ketoconazole

Certyfikat analizy

current certificate can be downloaded

metody

HPLC: suitable
gas chromatography (GC): suitable

Zastosowanie

pharmaceutical (small molecule)

Format

neat

temp. przechowywania

2-30°C

ciąg SMILES

CC(=O)N1CCN(CC1)c2ccc(OC[C@H]3CO[C@@](Cn4ccnc4)(O3)c5ccc(Cl)cc5Cl)cc2

InChI

1S/C26H28Cl2N4O4/c1-19(33)31-10-12-32(13-11-31)21-3-5-22(6-4-21)34-15-23-16-35-26(36-23,17-30-9-8-29-18-30)24-7-2-20(27)14-25(24)28/h2-9,14,18,23H,10-13,15-17H2,1H3/t23-,26-/m0/s1

Klucz InChI

XMAYWYJOQHXEEK-OZXSUGGESA-N

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Opis ogólny

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.
Ketoconazole is an imidazole antifungal agent administered through topical or oral means. It is used for the treatment of chronic mucocutaneous candidiasis, fungal infections of the gastro-intestinal tract, dermatophyte infections, systemic infections, and fungal infections in immuno-compromised patients.[1]

Zastosowanie

CYP3A4 inhibitor
Ketoconazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.[1][2][3]
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.

Działania biochem./fizjol.

Antifungal agent

Komentarz do analizy

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

Inne uwagi

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.

Przypis

To see an example of a Certificate of Analysis for this material enter LRAC3465 in the slot below. This is an example certificate only and may not be the lot that you receive.
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Hasło ostrzegawcze

Danger

Zwroty wskazujące rodzaj zagrożenia

H301,H360F,H373,H410

Zwroty wskazujące środki ostrożności

P202 - P260 - P264 - P273 - P280 - P301 + P310

Klasyfikacja zagrożeń

Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Repr. 1B - STOT RE 2

Kod klasy składowania

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

Klasa zagrożenia wodnego (WGK)

WGK 3

Temperatura zapłonu (°F)

Not applicable

Temperatura zapłonu (°C)

Not applicable

Wykazy regulacyjne

Wykazy regulacyjne dotyczą głównie produktów chemicznych. Można w nich podawać ograniczoną liczbę informacji na temat produktów niechemicznych. Brak wpisu oznacza, że żaden ze składników nie znajduje się w wykazie. Użytkownik odpowiada za zagwarantowanie bezpiecznego i zgodnego z prawem stosowania produktu.

EU REACH Annex XVII (Restriction List)

CAS No.

Wybierz jedną z najnowszych wersji:

Certyfikaty analizy (CoA)

Lot/Batch Number

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Loratadine Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1376

Loratadine

Comparison of capillary zone electrophoresis and high performance liquid chromatography methods for quantitative determination of ketoconazole in drug formulations
Velikinac I, et al.
Il Farmaco (Societa Chimica Italiana : 1989), 59(5), 419-424 (2004)
Chromatographic determination of clotrimazole, ketoconazole and fluconazole in pharmaceutical formulations
Abdel-Moety EM, et al.
Il Farmaco (Societa Chimica Italiana : 1989), 57(11), 931-938 (2002)
R A Bok et al.
Drug safety, 20(5), 451-458 (1999-05-29)
The definition of hormone refractory prostate cancer is changing. It has become clear that patients with advanced prostate cancer whose disease has progressed following treatment with luteinising hormone releasing hormone agonists and antiandrogens can respond to additional hormonal manoeuvres. Ketoconazole
María Castro-Puyana et al.
Electrophoresis, 26(20), 3960-3968 (2005-10-12)
EKC using a neutral CD as chiral selector was applied in this work to the development of a method enabling the enantiomeric separation of ketoconazole and terconazole antifungals. The influence of different experimental conditions such as temperature, CD concentration, pH
Jan Faergemann et al.
Expert opinion on pharmacotherapy, 8(9), 1365-1371 (2007-06-15)
Seborrhoeic dermatitis (SD) is a chronic, inflammatory skin disorder, affecting areas of the head and body where sebaceous glands are most prominent and active. The disorder commonly affects hair-bearing areas of the head, including the scalp. Involvement on the face
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Questions

1–2 of 2 Questions  

  1. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

  2. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

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