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Spectrophotometry

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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

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Elemental Analysis (C, H, N, S)

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Elementary Analysis & Coulometry

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Heavy Metals Testing

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Peptide & NCEs Limit Test

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

Bachem is committed to using synthesis and purification strategies that yield products of the quality and purity you require. Our standard analytical package typically includes mass spectrometric analysis and determination of purity (by RP-HPLC).

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Heavy Metal Test

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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USP <231> Heavy Metals Testing

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Elemental Impurities Testing

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Heavy Metal Determination

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

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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Elemental Analysis

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals

Eurofins BioPharma Product Testing has the wide range of chemistry expertise and state-of-the-art instruments required to perform all types of raw materials testing, including qualification of compendial methods, as well as development, qualification and validation of new methods.

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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