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Merck
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19041

Supelco

ICH Q3D口服药元素杂质混标1

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

别名:

TraceCERT元素杂质,根据ICH Q3D口服

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100 ML
$381.00

$381.00


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100 ML
$381.00

About This Item

UNSPSC代码:
41116107
NACRES:
NA.24

$381.00


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等级

certified reference material
TraceCERT®

质量水平

Agency

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

产品线

TraceCERT®

保质期

limited shelf life, expiry date on the label

组成

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

浓度

(in 12% nitric acid)

技术

ICP: suitable

包装形式

multi-component solution

一般描述

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.

制备说明

为制备这种CRM,仅可使用最高纯度的材料。

其他说明

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.

法律信息

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

免责声明

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

象形图

Corrosion

警示用语:

Danger

危险声明

危险分类

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

补充剂危害

WGK

WGK 3

闪点(°F)

Not applicable

闪点(°C)

Not applicable


历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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

相关内容

Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources

Questions

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  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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