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Merck

19041

Elemental Impurities according to ICH Q3D oral, Standard 1

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

Sinónimos:

TraceCERT Elemental Impurities according to ICH Q3D oral

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NACRES:
NA.24
UNSPSC Code:
41116107

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grade

certified reference material, TraceCERT®

agency

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

product line

TraceCERT®

shelf life

limited shelf life, expiry date on the label

composition

Ag, 150 mg/L , As, 15 mg/L , Cd, 5 mg/L , Co, 50 mg/L , Hg, 30 mg/L , Ni, 200 mg/L , Pb, 5 mg/L , Se, 150 mg/L , Tl, 8 mg/L , V, 100 mg/L

concentration

(in 12% nitric acid)

technique(s)

ICP: suitable

format

multi-component solution

Quality Level

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731088911889922
technique(s)

ICP: suitable

technique(s)

ICP: suitable

technique(s)

ICP: suitable

technique(s)

ICP: suitable

format

multi-component solution

format

multi-component solution

format

multi-component solution

format

multi-component solution

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

shelf life

limited shelf life, expiry date on the label

shelf life

limited shelf life, expiry date on the label

shelf life

limited shelf life, expiry date on the label

shelf life

limited shelf life, expiry date on the label

concentration

(in 12% nitric acid)

concentration

(in 10% hydrochloric acid)

concentration

(in 12% nitric acid)

concentration

(in 10% hydrochloric acid)

General description

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.

Search & download your certificate here.

Preparation Note

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

Other Notes

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.

Legal Information

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

Disclaimer

For U.S. Customers: Contains mercury; Do not place in trash - dispose according to local, state, or federal laws.

pictograms

Corrosion

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Danger

Hazard Classifications

Aquatic Chronic 3 - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

supp_hazards

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


Listados normativos

Los listados normativos se proporcionan para los productos químicos principalmente. Para los productos no químicos sólo se puede proporcionar información limitada. Si no hay ninguna entrada, significa que ninguno de los componentes está en la lista. Es obligación del usuario garantizar el uso seguro y legal del producto.

7440-48-4 + 7440-02-0 + 7440-38-2 + 10325-94-7 + 7439-92-1 + 10045-94-0 + 7782-49-2

CAS No.

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Artículos

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

Preguntas

1–2 de 2 Preguntas  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 respuesta
    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/418/501/product-dating-information-06-25-mk.pdf

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

    1 respuesta
    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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