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89118

Supelco

Elemental Impurities according to ICH Q3D parenteral, Standard 1

(in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

Sinonimo/i:

ICH Q3D Elemental Impurity Analysis Standard

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About This Item

Codice UNSPSC:
41116107
NACRES:
NA.24

CHF 284.00


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Grado

certified reference material
TraceCERT®

Livello qualitativo

agenzia

according to ICH Q3D
according to Ph. Eur.
according to USP

Nome Commerciale

TraceCERT®

Durata

limited shelf life, expiry date on the label

Composizione

Ag, 10 mg/L
As, 15 mg/L
Cd, 2 mg/L
Co, 5 mg/L
Hg, 3 mg/L
Ni, 20 mg/L
Pb, 5 mg/L
Se, 80 mg/L
Tl, 8 mg/L
V, 10 mg/L

Concentrazione

(in 12% nitric acid)

tecniche

ICP: suitable

Formato

multi-component solution

Descrizione generale

This certified reference material (CRM) is produced in accordance with ISO 17034 and characterized in accordance with ISO/IEC 17025. This CRM is traceable to SI unit kg and measured against primary material from a National Metrology Institute (NMI), e.g. NIST.

Please visit ISO certificates and Site Quality Self-Assessments to access the current certificates of accreditation.

Download your certificate at https://www.sigma-aldrich.com to view certified values, including uncertainty, date of expiry, and detailed information about trace impurities.

Nota sulla preparazione

For the preparation of this CRM only materials of highest purity were used.

Altre note

We provide a diverse range of certified reference materials, including various elemental impurity mixes and single elements, with concentration limits that comply with ICH Q3D guidelines. For more information please visit our Inorganic Elemental Impurity Mix Standards.

In our effort to be more sustainable, we′re going digital with COAs-download them directly from our website.

Note legali

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

Pittogrammi

Corrosion

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

Rischi supp

Classe di pericolosità dell'acqua (WGK)

WGK 2


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Certificati d'analisi (COA)

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Articoli

Control elemental impurities in drug products with analytical methods and materials to ensure patient safety.

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

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  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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