IV Product Catalog 2020 v19

I C P - O E S & I C P – M S M U L T I - E L E M E N T S T A N D A R D S

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For the pharmaceutical industry, Inorganic Ventures has developed CRMs to comply with the United States Pharmacopeia (USP) general chapters on elemental impurity USP <232> limits and USP <233> procedures. These methods are for testing inorganic impurities in pharmaceutical products by ICP. The International Conference on Harmonization (ICH) Working Group on Elemental Impurities is in the process of developing a harmonized approach for controlling these impurities as well.

USP <232> / ICH Q3D Class 1 Oral Elemental Impurities

USP <232> / ICH Q3D Class 2B Oral Elemental Impurities

IV-STOCK-65

IV-STOCK-67

Matrix: HNO 3

Matrix: HCl

IV-STOCK-65-125ML IV-STOCK-65-500ML

IV-STOCK-67-125ML IV-STOCK-67-500ML

Volume: 125 mL Volume: 500 mL

Volume: 125 mL Volume: 500 mL

Analyte

µg/mL

Analyte

µg/mL

Analyte

µg/mL

Analyte

µg/mL

As Cd

15

Hg Pb

30

Au

100 100 100 100 100

Rh Ru Se

100 100 150

5

5

Ir

Os Pd

Tl

8

USP <232> / ICH Q3D Class 2A Oral Elemental Impurities

Pt

USP <232> / ICH Q3D Class 2B Oral Elemental Impurities

IV-STOCK-66

Matrix: HNO 3

IV-STOCK-66-125ML IV-STOCK-66-500ML

Volume: 125 mL Volume: 500 mL

IV-STOCK-68

Matrix: HNO 3

IV-STOCK-68-125ML IV-STOCK-68-500ML

Volume: 125 mL Volume: 500 mL

Analyte

µg/mL

Analyte

µg/mL

Co Ni

50

V

100

Analyte

µg/mL

Analyte

µg/mL

200

Ag* 150 * Silver has been separated from the other Class 2B elements due to long-term stability concerns. However, IV-STOCK-68 can be combined with IV-STOCK-67 at working levels. Contact Technical Support or visit our Technical Forum for more information regarding Ag in HCl matrices.

USP <232> / ICH Q3D Oral Elemental Impurities

IV-STOCK-70

Matrix: HCl

IV-STOCK-70-125ML IV-STOCK-70-500ML

Volume: 125 mL Volume: 500 mL

USP <232> / ICH Q3D Class 3 Oral Elemental Impurities

Analyte

µg/mL

Analyte

µg/mL

Ag As Au Ba Cd Co Cr Cu Hg

15

Ni Os Pb Pd Rh Ru Sb Se Sn Pt

20 10

1.5

IV-STOCK-69

Matrix: HNO 3 /tr HF

10

0.5

IV-STOCK-69-125ML IV-STOCK-69-500ML

Volume: 125 mL Volume: 500 mL

140 0.5

10 10 10 10

Analyte

µg/mL

Analyte

µg/mL

5

Ba Cr Cu

140

Mo

300 120 600

1100

1100

Sb Sn

300

120

300

3

15

Li

55

Ir

10 55

600

Li

Tl

0.8

Mo

300

V

10

USP Method <232>

USP Method <232> — Elemental Impurities Compliance Standards

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