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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

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Siegfried AG

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Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

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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 BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

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Bachem offers other analytical techniques such as Amino Acid Analysis (AAA), Elemental Analysis (CHN), Enantiomer Content, Polarimetry, Refractometry, Titration, Turbidimetry, Osmolality, Total Organic Carbon (TOC), Total Viable Aerobic Counts, etc

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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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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