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PHR1662

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Amphotericin B

Pharmaceutical Secondary Standard; Certified Reference Material

Synonim(y):

Amphotericin B

Zaloguj sięWyświetlanie cen organizacyjnych i kontraktowych

Wybierz wielkość

500 MG
1730,00 zł

1730,00 zł


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500 MG
1730,00 zł

About This Item

Wzór empiryczny (zapis Hilla):
C47H73NO17
Numer CAS:
Masa cząsteczkowa:
924.08
Numer WE:
Kod UNSPSC:
41116107
NACRES:
NA.24

1730,00 zł


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Poproś o zamówienie zbiorcze

klasa czystości

certified reference material
pharmaceutical secondary standard

Poziom jakości

agency

traceable to Ph. Eur. Y0000005
traceable to Ph. Eur. Y0001361
traceable to USP 1032007
traceable to USP

rodzina API

amphotericin b

Certyfikat analizy

current certificate can be downloaded

opakowanie

pkg of 500 mg

metody

HPLC: suitable
gas chromatography (GC): suitable

Zastosowanie

pharmaceutical (small molecule)

Format

neat

temp. przechowywania

-10 to -25°C

ciąg SMILES

N[C@@H]1[C@@H]([C@@H](O[C@@H]([C@H]1O)C)O[C@@H]2C[C@@H]3O[C@@](C[C@@H]([C@H]3C(=O)O)O)(C[C@H](C[C@H]([C@@H](CC[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]([C@H](\C=C/C=C\C=C/C=C\C=C/C=C\C=C/2)C)O)C)C)O)O)O)O)O)O)O

InChI

1S/C47H73NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-33(51)22-36(53)35(52)20-19-31(49)21-32(50)23-39(55)62-29(3)28(2)42(27)56/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60)/b6-5-,9-7-,10-8-,13-11-,14-12-,17-15-,18-16-/t27-,28-,29-,30+,31+,32+,33-,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1

Klucz InChI

APKFDSVGJQXUKY-ZNVUZQDLSA-N

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Opis ogólny

Amphotericin B is a macrolide antibiotic used to treat systemic fungal infections.[1]
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.

Zastosowanie

Amphotericin B may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography technique.[1]
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.

Komentarz do analizy

These secondary standards offer multi-traceability to the USP, EP 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 LRAC1692 in the slot below. This is an example certificate only and may not be the lot that you receive.
Ta strona może zawierać tekst przetłumaczony maszynowo.

Piktogramy

Health hazard

Hasło ostrzegawcze

Danger

Zwroty wskazujące rodzaj zagrożenia

Zwroty wskazujące środki ostrożności

Klasyfikacja zagrożeń

STOT RE 1

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


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Certyfikaty analizy (CoA)

Lot/Batch Number

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Slide 1 of 6

1 of 6

High-performance liquid chromatographic determination of amphotericin B in a liposomal pharmaceutical product and validation of the assay
Eldem T and Arican-Cellat N
Journal of Chromatographic Science, 38(8), 338-344 (2000)
Small Animal Clinical Pharmacology (2008)
Desiree Van Haute et al.
International journal of pharmaceutics, 569, 118603-118603 (2019-08-12)
Conventional quantitation of drug content in the liposome formulation involves the breakdown of bulk liposomes, which ignores details on the distribution of the active pharmaceutical ingredient (API) and excipients in liposomes of different sizes. The objective of this study is

Questions

1–2 of 2 Questions  
  1. 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

      Helpful?

  2. 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?

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