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Heavy Metals Testing – USP <232>/<233>
USP Heavy Metals Testing: Elemental impurity testing per USP <232>/<233> for lead, mercury, arsenic, cadmium, and antimony.
Price per sample:
$225
Additional information
| Turnaround Time | 2 weeks |
|---|---|
| Sample Size | 10 grams |
Heavy Metals Testing – USP <232> / <233>
Overview of USP Elemental Impurity Testing
USP heavy metals testing evaluates elemental impurities in products using the requirements defined in USP <232> and USP <233>. Pentyl Labs performs this testing to help manufacturers confirm product safety, quality, and regulatory compliance across pharmaceutical, cosmetic, dietary supplement, and consumer product categories.
USP <232> establishes permitted daily exposure limits for elemental impurities, while USP <233> describes validated analytical procedures used to measure these elements accurately. Together, these chapters form the global standard for elemental impurity control.
Elements Commonly Screened Under USP <232>
Elemental impurity screening under USP guidelines typically includes the following elements and limits:
-
Lead (Pb): < 1 ppm
-
Mercury (Hg): < 1 ppm
-
Arsenic (As): < 3 ppm
-
Cadmium (Cd): < 3 ppm
-
Antimony (Sb): < 5 ppm
These metals may present health risks even at low concentrations, which makes accurate testing essential.
Analytical Method and Instrumentation
Pentyl Labs performs elemental impurity analysis using inductively coupled plasma mass spectrometry (ICP-MS) in accordance with USP <233>. This technique provides high sensitivity, precision, and selectivity for trace-level metal detection.
Careful sample preparation allows reliable analysis of complex matrices, including powders, tablets, liquids, creams, and raw materials. The method meets USP validation requirements for accuracy, precision, specificity, and robustness.
Why Manufacturers Request USP-Based Testing
Manufacturers request elemental impurity testing to support regulatory submissions, quality audits, and product release decisions. Testing also supports product development, reformulation projects, and supplier qualification programs.
In addition, analytical data helps identify potential contamination sources such as excipients, pigments, botanical ingredients, or processing equipment. Early detection allows corrective action before products reach the market.
Use of Test Results
Test results support internal safety reviews, customer documentation, and compliance assessments. Manufacturers use the data to confirm that impurity levels remain within USP limits and align with internal specifications.
This service is commonly used alongside Chemical Analysis Services and Heavy Metals Testing Programs to provide a more complete view of formulation safety and quality.
Requirements for USP <232>/<233> are maintained by the United States Pharmacopeia (USP), which defines elemental impurity limits and analytical expectations.
Summary
Overall, elemental impurity testing under USP standards provides dependable analytical data that supports regulatory compliance, product safety, and quality assurance. ICP-MS offers a trusted approach for monitoring trace metals across a wide range of products.
Description
Heavy Metals Testing – USP <232> / <233>
Overview of USP Elemental Impurity Testing
USP heavy metals testing evaluates elemental impurities in products using the requirements defined in USP <232> and USP <233>. Pentyl Labs performs this testing to help manufacturers confirm product safety, quality, and regulatory compliance across pharmaceutical, cosmetic, dietary supplement, and consumer product categories.
USP <232> establishes permitted daily exposure limits for elemental impurities, while USP <233> describes validated analytical procedures used to measure these elements accurately. Together, these chapters form the global standard for elemental impurity control.
Elements Commonly Screened Under USP <232>
Elemental impurity screening under USP guidelines typically includes the following elements and limits:
-
Lead (Pb): < 1 ppm
-
Mercury (Hg): < 1 ppm
-
Arsenic (As): < 3 ppm
-
Cadmium (Cd): < 3 ppm
-
Antimony (Sb): < 5 ppm
These metals may present health risks even at low concentrations, which makes accurate testing essential.
Analytical Method and Instrumentation
Pentyl Labs performs elemental impurity analysis using inductively coupled plasma mass spectrometry (ICP-MS) in accordance with USP <233>. This technique provides high sensitivity, precision, and selectivity for trace-level metal detection.
Careful sample preparation allows reliable analysis of complex matrices, including powders, tablets, liquids, creams, and raw materials. The method meets USP validation requirements for accuracy, precision, specificity, and robustness.
Why Manufacturers Request USP-Based Testing
Manufacturers request elemental impurity testing to support regulatory submissions, quality audits, and product release decisions. Testing also supports product development, reformulation projects, and supplier qualification programs.
In addition, analytical data helps identify potential contamination sources such as excipients, pigments, botanical ingredients, or processing equipment. Early detection allows corrective action before products reach the market.
Use of Test Results
Test results support internal safety reviews, customer documentation, and compliance assessments. Manufacturers use the data to confirm that impurity levels remain within USP limits and align with internal specifications.
This service is commonly used alongside Chemical Analysis Services and Heavy Metals Testing Programs to provide a more complete view of formulation safety and quality.
Requirements for USP <232>/<233> are maintained by the United States Pharmacopeia (USP), which defines elemental impurity limits and analytical expectations.
Summary
Overall, elemental impurity testing under USP standards provides dependable analytical data that supports regulatory compliance, product safety, and quality assurance. ICP-MS offers a trusted approach for monitoring trace metals across a wide range of products.
