跳转至内容
Merck
CN
所有图片(1)

文件

69729

Supelco

ICH Q3D口服药元素杂质混标3

TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

别名:

ICH Q3D oral elemental impurities

登录查看公司和协议定价
所有图片(1)

About This Item

UNSPSC代码:
41116107
NACRES:
NA.24

等级

certified reference material
TraceCERT®

质量水平

300

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

Ba, 140 mg/L
Cr, 1100 mg/L
Cu, 300 mg/L
Li, 55 mg/L
Mo, 300 mg/L
Sb, 120 mg/L
Sn, 600 mg/L

浓度

in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid )

技术

ICP: suitable

格式

multi-component solution

相关类别

一般描述

该认证标准物质（CRM）根据ISO/IEC 17025和ISO 17034生产和认证。该 CRM 可追溯到 SI 单位千克，并根据 NMI 中的主要材料（例如 NIST）进行测量。
认证内容包括标识在证书上的不确定性和有效期。
请访问http://www.sigma-aldrich.com下载您的证书。

应用

  • ICH Q3D elemental impurities testing guidelines: A study conducted rapid screening of pharmaceutical products for elemental impurities using a high-resolution portable energy dispersive X-ray fluorescence spectrometer. This method adheres to ICH Q3D guidelines for oral dosage forms, offering an efficient tool for routine quality control in pharmaceutical manufacturing (Zhu et al., 2023).
  • Elemental impurity analysis for pharmaceuticals: Research focused on the human health risk assessment of total chromium impurities in cough syrups. This study aligns with ICH Q3D regulations, emphasizing the need for rigorous testing of oral pharmaceuticals to ensure consumer safety, particularly regarding the toxic potential of elemental impurities (Jurowski and Krosniak, 2024).
  • Pharmaceutical trace metal contamination standards: The determination of ICH-Q3D elemental impurity leachables in glass vials was explored using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). This research underscores the importance of assessing leachable heavy metals in drug packaging to prevent contamination of oral drug products (Breckenridge et al., 2023).

制备说明

为制备这种CRM，仅可使用最高纯度的材料。

法律信息

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

相关产品

产品编号
说明
价格

19041

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

73108

ICH Q3D口服药元素杂质混标2, TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

89922

元素杂质混标2，符合ICH Q3D注射用, TraceCERT®, (in 10% hydrochloric acid), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

07368

元素杂质混标3，符合ICH Q3D注射用, TraceCERT®, in nitric acid and hydrofluoric acid (5% nitric acid and <0.5% hydrofluoric acid ), applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

89118

元素杂质混标1，符合ICH Q3D注射用, (in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20

象形图

CorrosionExclamation mark
GHS05,GHS07

警示用语：

Danger

危险分类

Acute Tox. 4 Dermal - Acute Tox. 4 Oral - Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B

补充剂危害

EUH071

WGK

WGK 1

闪点(°F)

Not applicable

闪点(°C)

Not applicable

Choose from one of the most recent versions:

分析证书(COA)

Lot/Batch Number
BCCL8168
BCCJ8596
BCCJ5771
BCCG5468
BCCF3454

Don't see the Right Version?

If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

Search for a COA

已有该产品？

在文件库中查找您最近购买产品的文档。

访问文档库

商品

Elemental Impurities - Certified Ref. Materials

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

我们的科学家团队拥有各种研究领域经验，包括生命科学、材料科学、化学合成、色谱、分析及许多其他领域.

联系技术服务部门