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Spectrophotometry

Analytical >> Analytical Testing Services >> Trace / Elemental / Heavy Metals, 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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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 Metals Testing USP <231>, <232>, and <233>

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

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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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 Analysis

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

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

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Trace, Heavy Metals & Elemental Impurities Testing

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

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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USP <232> Elemental Impurities – Limits

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

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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Limit Tests For Heavy Metals

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

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.

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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