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07368

Elemental Impurities according to ICH Q3D parenteral, cutaneous and transcutaneous, Standard 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

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100 mL
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CZK 6,130.00

About This Item

NACRES:
NA.24
UNSPSC Code:
41116107

CZK 6,130.00


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Quality Segment

agency

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

product line

TraceCERT®

grade

certified reference material, TraceCERT®

shelf life

limited shelf life, expiry date on the label

composition

Ba, 70 mg/L , Cr, 110 mg/L , Cu, 30 mg/L , Li, 25 mg/L , Mo, 150 mg/L , Sb, 9 mg/L , Sn, 60 mg/L

concentration

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

technique(s)

ICP: suitable

format

multi-component solution

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.

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

Application

Elemental Impurities according to ICH Q3D parenteral, Standard 3 may be used as a reference standard for screening of elemental impurities in pharmaceutical products in compliance with United States Pharmacopoeia (USP) and ICH-Q3D.

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

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This Item
697298992289118
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

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

grade

certified reference material, TraceCERT®

agency

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

agency

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

agency

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

agency

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

composition

Ba, 70 mg/L , Cu, 30 mg/L , Mo, 150 mg/L , Sn, 60 mg/L , Cr, 110 mg/L , Sb, 9 mg/L , Li, 25 mg/L

composition

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

composition

Au, 100 mg/L , Ir, 10 mg/L , Os, 10 mg/L , Pd, 10 mg/L , Pt, 10 mg/L , Rh, 10 mg/L , Ru, 10 mg/L

composition

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

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300


pictograms

CorrosionExclamation mark

signalword

Danger

Hazard Classifications

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

supp_hazards

Storage Class

8B - Non-combustible corrosive hazardous materials

flash_point_f

Not applicable

flash_point_c

Not applicable



Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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