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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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A new ASTM International standard determines polymer content in alpha-methylstyrene (AMS), a raw material used in the production of a variety of consumer products. AMS manufacturers and those who use AMS as a raw material will be the primary beneficiaries of the new standard (soon to be published as D7977, Test Method for Polymer Content of a-Methylstyrene (AMS)). In addition, third party…, ASTM Committee D16 on Aromatic Hydrocarbons and Related Chemicals Next Meeting:, June 24-25, 2015, in conjunction with ASTM D02 committee meeting, Ft. Lauderdale, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Scott Keenan, Ph.D., tel +1.215.537.2434; scott.keenan2@honeywell.com, ASTM Staff Contact:, Kristy Straiton, tel +1.610.832.9640; kstraiton@astm.org Release #9798 ###
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Purified terephthalic acid, commonly known as PTA, is a major raw material for polymer and plastic manufacture used in making polyester fiber, resin and film. Four new ASTM International standards will be used to determine the presence of the impurities 4-Caraboxybenzaldehyde and p-Toluic Acid in PTA. The four new standards were developed by Subcommittee D16.02 on Oxygenated Aromatics , part of…, ASTM Committee D16 Next Meeting:, Jan. 29-30, 2014, January Committee Week, Houston, Texas, Technical Contact:, Yuhong Zhang, China Petrochemical Corp., Shanghai, China, Phone: 86-21-6846-2281; zhang-yh10@163.com, ASTM Staff Contact:, Kristy Straiton, Phone: 610-832-9640; kstraiton@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9526
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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Purified terephthalic acid, often known simply as PTA, is in high demand as the key raw material for the manufacture of polyester fiber, resin and film. Two proposed ASTM standards are currently being developed that will be used to find major impurities in PTA product. The two proposed standards are ASTM WK36121 , Test Method for Determination of p-Toluic Acid and 4-Carboxybenzaldehyde in…, ASTM Committee D16 Next Meeting:, Jan. 30-31, 2013, January Committee Week, Jacksonville, Fla., Technical Contact:, Yuhong Zhang, China Petrochemical Corp., Shanghai, China, Phone: 011-86-21-68462281; zhangyh.sshy@sinopec.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9266
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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Increasing interest in the various uses of electrical contacts is the leading impetus for the development of a proposed new standard, ASTM WK34423 , Specification for Electrodeposited Coatings of Palladium-Cobalt Alloy for Engineering Use. The proposed standard is being developed by Subcommittee B08.08 on Metallic Coatings , part of ASTM International Committee B08 on Metallic and Inorganic…, ASTM Committee B08 Next Meeting:, May 10, 2012, May Committee Week, Phoenix, Ariz., Technical Contact:, Sheikh H. Rahman, Lean Corp., Southfield, Mich., Phone: 248-447-1526; srahman@lear.com, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9016
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A new ASTM subcommittee seeks to acknowledge the ongoing advances being made in the field of nanostructured inorganic coatings. B08.16 on Nanostructured Coatings, part of ASTM International Committee B08 on Metallic and Inorganic Coatings, is currently developing its first proposed standard, ASTM WK29468 , Specification for Galvanic Protection of Steel Using a Nanostructured Coating of 95 % Zinc…
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Manufacturers of toluene, mixed xylenes and p-xylene are often required to determine the type and amount of impurities that remain from manufacture. A new ASTM International standard, D7504 , Test Method for Trace Impurities in Monocyclic Aromatic Hydrocarbons by Gas Chromatography and Effective Carbon Number, can now be used as an internal quality control tool where these products are produced…
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…