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The pharmaceutical industry is heavily regulated beyond all other industries. This is for a good reason because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care. Regulation has led to the mandatory examination of all substances from starting materials to finished products. Generally this includes the proof of product stability, drug-release profiles, Active Pharmaceutical-Ingredient (API) form, API quantification, and product safety including sterility (for non-biological materials) and foreign materials including heavy-metals. One of the most common product safety-related analytical tests (often referred to as a Limit Test) is the quantification of heavy metals or inorganics in all materials within a pharmaceutical product. This normally includes the toxic heavy metals such as As, Hg and Pb. Most of the elements identified for heavy metal Limit Testing have been well documented as significant health risks with numerous effects from organ failure to blindness and even death. It is also common practice to measure catalysts, such as Pd and Pt, which are also well classified toxic elements. Throughout the manufacturing processes there are many potential sources of contamination. Therefore, in addition to measuring the starting materials it is essential to measure all finished products and in some cases intermediates, to demonstrate the compliancy with the various regulations. The testing of trace metals in drug products, drug substances, biologics, dietary supplements, and medical devices is critical in determining the toxicity of a material and predicting its interactions with other compounds. Testing for elemental impurities by ICPOES and ICPMS, in compliance with USP <233>, EP (2.4.20), and ICH Q3D gives you reliable, independent data for both raw materials and finished products. Contract analytical service providers can assist with the information you need on the presence of a full spectrum of trace and heavy metals. We also have the capability to separate and quantitate inorganic mercury, arsenic, and selenium from their various organic species. Trace metals analysis by ICPMS is also the method of choice to determine residual catalysts, such as palladium and platinum, in in-process intermediates and final products. As an addition to trace metal analysis, service providers also offer full compendial Active Pharmaceutical Ingredients (API) and excipient testing to the EP, BP, JP, and USP compendia.

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ACTA Laboratories Inc

AMRI

Anacipher

Angelini Pharmaceuticals ACRAF

Arbro Pharmaceuticals Pvt. Ltd

Arevipharma GmbH

Bachem AG

Boston Analytical

CARBOGEN AMCIS AG

Cebiphar

ChemCon GmbH

Chemtos

Dalton Pharma Services

Diverchim S.A.

GRAM Laboratory Inc

GVK Biosciences

Grace

Jubilant HollisterStier

Labiana Life Sciences S.A

Megsan Labs Private Limited

Nutrasource

Pace Analytical Services, LLC

Primera Analytical Solutions Corp

Quantex Laboratories

RD Laboratories

SEQUENT SCIENTIFIC LTD

Servier CDMO

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Siegfried AG

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Heavy Metals Testing

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AMRI has the capability to perform USP <232> and USP <233> testing, including heavy metals testing and testing on drug substances, excipients, drug products and dietary supplements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

Virtual BoothSpecializes in development of innovative, efficient manufacturing processes & reliable production of peptide-based APIs

Peptide & NCEs Limit Test

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Over the years, Bachem has gathered an extensive know-how not only in the synthesis of active pharmaceutical ingredients, peptides as well as small molecules, but also in the analysis of these compounds.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Process Control & Material Characterization

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Carbogen Amcis SAS has established a service supporting our customers with crystallization investigations including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

Virtual BoothGMP APIs & Flow Chemistry from a Leader in the Healthcare & Wellbeing market in the Pharma & Mass-market sectors

Elemental Analysis (C, H, N, S)

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Your GMP “One-Stop-Shop”, Angelini Fine Chemicals is a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Heavy Metals Testing USP <231>, <232>, and <2...

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ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs USP <231> (wet chemistry testing for heavy metals) and USP <232>/<233> (ICP-MS testing for Elemental Impurities) on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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USP <231> Heavy Metals Testing

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The current procedure in the USP for Heavy Metals testing is a wet chemistry test that utilizes sulfide to precipitate certain heavy metals (Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu, and Mo). The test sample preparation is visually examined to see if it is darker than the standard.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elemental Analysis

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R.D. Laboratories has significant expertise and a variety of specialized equipment to assist with inorganic impurity testing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Limit Tests For Heavy Metals

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Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Trace, Heavy Metals & Elemental Impurities Te...

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For 25 years Quantex has been involved with developing and executing methods for trace and heavy metals analysis employing modern quantitative technologies.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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USP <232> Elemental Impurities – Limits

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The new ICP-MS procedures are quantitative and will provide an accurate assessment of elemental impurities. The USP <232> Elemental Impurities Limits lists the proposed limits for allowable levels of elemental impurities in drug products and drug substances.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Heavy Metal Analysis by ICP/MS

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Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elemental Impurities Testing

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Heavy Metals Testing

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To ensure your product complies with the regulations, we offer testing for most metals via ICP-MS equipment providing very low detection limits.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Combustion Elemental Analysis

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Chemtos' other analysis that are available upon request include Combustion Elemental Analysis

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Heavy Metal Test

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elemental Analysis -Trace Metal Analysis

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Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Mercury Tracing

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R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Trace Analysis

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Arevipharma develops, validates and transfers new methods of analysis, this is done also in the field of trace analysis, e.g. for potential genotoxic substances. Thorough reporting is included, of course.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Selenium Tracing

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R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elemental Analysis via Inductively Coupled Pl...

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Determination of Elements

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Arevipharma puts focus on the process development of stable and robust chemical synthesis routes, and its quality management to ensure its Active Pharmaceutical Ingredients (API) are of the highest quality.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Compatibility with Metal Ions

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GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elementary Analysis & Coulometry

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Thanks to its innovative techniques (HPLC, SFC or combined preparative HPLC/SFC), DIVERCHIM proposes to its customers to isolate, purify and characterize process impurities as well as reference compounds.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Particulate Analysis – USP <788> and USP <7...

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Boston Analytical offers an extensive line of microbiological testing services for pharmaceuticals. Our FDA/DEA Registered, cGMP compliant, and ISO/IEC-17025:2005 certified laboratory is well equipped with the latest technology and instrumentation, ensuring timely and accurate testing results.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Metal Detection

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Servier CDMO has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. Servier has 60 years of experience with a proven track record of quality and regulatory approval to ensure reliability for your

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Trace Analysis & Carry Over Studies

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Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Heavy Metal Determination

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Siegfried recognizes and understands the importance of requisite analytical parameters & controls, as they are vital for ensuring effective and robust processes.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Elemental Analysis

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Trace Analysis in Surface Controls

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In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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ICP-OES

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Grace Albany Fine Chemicals' site is designed to meet customers' highest quality, regulatory, and confidentiality expectations for the manufacture of fine chemicals and intermediates.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Metals Analysis by ICP

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Jubilant HollisterStier’s innovative microbiological and analytical labs are operated by experienced professionals using the most current equipment and procedures to ensure seamless technical transfer of analytical methods for our clients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Total Organic Carbon (TOC) Determination

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Chemcon's analytic machines are regularly calibrated and qulified. Our analytical suite is state-of-the-art and is being extended continuously.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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ICP-MS Elemental Analysis

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In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Dalton now offers ICP-MS testing services.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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CHNS Analyser - Elementor

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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Spectrophotometry

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Our technical platforms encompasses, among others: UV-visible spectrophotometers, infra-red spectrometer, atomic absorption spectrophotometer (SAA) flame & oven, colorimeter.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

The pharmaceutical industry is heavily regulated beyond all other industries. This is for a good reason because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care. Regulation has led to the mandatory examination of all substances from starting materials to finished products. Generally this includes the proof of product stability, drug-release profiles, Active Pharmaceutical-Ingredient (API) form, API quantification, and product safety including sterility (for non-biological materials) and foreign materials including heavy-metals. One of the most common product safety-related analytical tests (often referred to as a Limit Test) is the quantification of heavy metals or inorganics in all materials within a pharmaceutical product. This normally includes the toxic heavy metals such as As, Hg and Pb. Most of the elements identified for heavy metal Limit Testing have been well documented as significant health risks with numerous effects from organ failure to blindness and even death. It is also common practice to measure catalysts, such as Pd and Pt, which are also well classified toxic elements. Throughout the manufacturing processes there are many potential sources of contamination. Therefore, in addition to measuring the starting materials it is essential to measure all finished products and in some cases intermediates, to demonstrate the compliancy with the various regulations. The testing of trace metals in drug products, drug substances, biologics, dietary supplements, and medical devices is critical in determining the toxicity of a material and predicting its interactions with other compounds. Testing for elemental impurities by ICPOES and ICPMS, in compliance with USP <233>, EP (2.4.20), and ICH Q3D gives you reliable, independent data for both raw materials and finished products. Contract analytical service providers can assist with the information you need on the presence of a full spectrum of trace and heavy metals. We also have the capability to separate and quantitate inorganic mercury, arsenic, and selenium from their various organic species. Trace metals analysis by ICPMS is also the method of choice to determine residual catalysts, such as palladium and platinum, in in-process intermediates and final products. As an addition to trace metal analysis, service providers also offer full compendial Active Pharmaceutical Ingredients (API) and excipient testing to the EP, BP, JP, and USP compendia.

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