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Chemical Analysis & Testing Standards

Wet chemistry analysis test standards
ACS American Chemical Society
AOAC Association of Official Analytical Chemists
ASTM American Society for Testing and Materials
FCC Federal Communications Commission
EP European Pharmacopeia
JP Japanese Pharmacopeia
USP/NF The United States Pharmacopoeia /The National Formulary

See alphabetical listing of tests

American Chemical Society (ACS)

The American Chemical Society Committee on Analytical Reagents sets the specifications for most chemicals used in analytical testing. Currently, ACS is the only organization in the world that sets requirements and develops validated methods for determining the purity of reagent chemicals. These specifications have also become the de facto standards for chemicals used in many high-purity applications. Publications and organizations that set specifications or promulgate analytical testing methods—such as the United States Pharmacopeia and the U.S. Environmental Protection Agency—specify that ACS Reagent-grade purity be used in their test procedures.
The ACS Committee on Analytical Reagents evolved from the Committee on the Purity of Chemical Reagents, which was established in 1903. Analysts at that time were disturbed by the quality of reagents available and by the discrepancies between labels and the actual purity of the materials. The Committee’s role in resolving these issues expanded rapidly after its 1921 publication of specifications for ammonium hydroxide and for hydrochloric, nitric, and sulfuric acids. Specifications appeared initially in Industrial & Engineering Chemistry and later in its Analytical Edition. In 1941, the existing specifications were reprinted in a single pamphlet. Revisions and new specifications were later gathered into a book, the 1950 edition of Reagent Chemicals, and new editions appeared regularly thereafter.
The commonplace introduction of instrumentation into analytical laboratories, beginning in the late 1950s, resulted in dramatic improvements in the sensitivity and accuracy of analytical measurements. As a result, the specifications for reagent chemicals and the tests measuring their purity were improved so that the test methods would be as accurate and cost-effective as possible. The Eighth Edition, which became official in 1993, substantially changed and updated the general procedures and attempted to make the book easier to read. The Ninth Edition, which became official in 2000, continued the trend toward eliminating or simplifying some of the tedious classical procedures for trace analysis and adding instrumental methods where possible.

[Courtesy of http://pubs.acs.org/reagents/demo/intro/06-Preface.html]

Association of Official Analytical Chemists (AOAC)

Association of Official Analytical Chemists (AOAC International) is a 120 year-old not-for-profit scientific association committed to worldwide confidence in analytical results. In fact, “worldwide confidence in analytical results” is AOAC’s vision.

To attain the vision, AOAC serves the communities of analytical sciences by providing the tools and processes necessary for community stakeholders to collaborate and, through consensus building, develop fit-for-purpose methods and services for assuring quality measurements. This is AOAC’s mission.

Leveraging the knowledge, experience, and expertise of more than 2,700 of its members with one-third of its members outside the US, AOAC has developed many competencies, programs, and a proven model to achieve its mission and vision and bring value to the analytical communities that AOAC serves. What do we mean by an AOAC community?

An AOAC community is a group of analytical scientists in a specific area who share AOAC’s vision of worldwide confidence in analytical results and who are brought together by a leader or “champion” to do together what they cannot do alone. Representatives of a community include scientific experts from various government agencies, industry, trade associations, international organizations, and academia. Following a proven AOAC model, stakeholders of a community work through consensus to prioritize methods needs, establish performance criteria for the methodology, and drive the development and validation of the best and most needed methods. The validation is conducted according to established and internationally recognized AOAC validation guidelines and this fact and recognition brings tremendous value to those who come to AOAC to validate methods. With 120 years of methods validation experience, we know how to do validation and have the ability to facilitate the development and approval of methods that promote trust and confidence in analytical results, thereby facilitating and promoting interstate and international trade, public trust in manufacturers’ products, and public safety and security.

Because confidence in analytical results also depends on other complementary tools, the community may opt to have AOAC qualify the laboratories doing the analyses, train the analysts, and provide proficiency testing.

Under the auspices of AOAC International, communities have the ability for open communications and decision making based on consensus, sharing of resources both financial and expertise, preventing duplication of efforts, and validating methods that are of outmost importance to the communities. The methods that result from the communities’ work are accepted internationally and are used by regulatory and industry scientists alike for many purposes including public health and safety, regulation, trade, monitoring, and quality control. AOAC has a number of communities in various stages of development including food safety and security, agricultural materials, marine and freshwater toxins, dietary supplements, food allergens, and disinfectants. The result of the work of AOAC communities, staff, and network of volunteers are AOAC® Official MethodsSM, the “gold standard” of methods accepted and recognized by regulatory agencies and organizations worldwide. In fact, many AOAC methods are specifically required in the enforcement of some state, provincial, municipal, and local laws and many federal food standards worldwide.

AOAC has official observer status in Codex Alimentarius since its inception allowing AOAC the ability to give input on the development of international standards for foods and agriculture. Because of AOAC’s proven recognition and credibility, if there is an AOAC method available, it generally will be accepted into a Codex standard. As of today, majority of the analytical methods cited in Codex standards are those of AOAC. With Codex being an organization supported by the World Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations, representing 168 countries worldwide, AOAC methods are recognized at the highest level in the world and thus generally the methods of choice by governments of those countries. AOAC “Official Methods of Analysis” have been defined as “official” by regulations promulgated for enforcement of the Food, Drug, and Cosmetic Act (21 CFR 2.19), recognized in Title 9 of USDA-FSIS Code of Federal Regulations, and in some cases by the US Environmental Protection Agency.

[Courtesy of http://www.aoac.org/about/aoac.htm]

American Society for Testing Materials (ASTM)

American Society for Testing Materials (ASTM International) is an international standards developing organization that develops and publishes voluntary technical standards for a wide range of materials, products, systems, and services. ASTM International develops standards using a consensus process.

ASTM International was formed in 1898 in the United States as the American Society for Testing and Materials by a group of scientists and engineers, led by Charles Benjamin Dudley, to address the frequent rail breaks plaguing the fast-growing railroad industry. The group developed a standard for the steel used to fabricate rails. It predates other standards organizations such as BSI (1901), DIN (1917) and AFNOR (1926), but differs from these in that it is not a national standards body, that role being taken in the USA by ANSI. However, it has a dominant role among standards developers in the USA, and claims to be the world's largest developer of standards.

Today, ASTM International supports thousands of technical committees, which draw their members from around the world and collectively maintain more than 12,000 standards. The Annual Book of ASTM Standards consists of 77 volumes.

Standards

The standards produced by ASTM International fall into four categories:

  • The Standard Specification, that defines the requirements to be satisfied by subject of the standard.
  • The Standard Test Method that defines the way a test is performed. The result of the test may be used to assess compliance with a Specification.
  • The Standard Practice that defines a sequence of operations that, unlike a test, does not produce a result.
  • The Terminology Standard, that provides agreed definitions of terms used in the other standards.

The quality of the standard test methods is such that they are frequently used world-wide, even in places where ASTM specifications are not used.

[Courtesy of http://en.wikipedia.org/wiki/ASTM_International]

Food Chemicals Codex (FCC)

After 40 years and the publication of five editions of the Food Chemicals Codex (FCC) as an activity of the Institute of Medicine’s (IOM) Food and Nutrition Board, the National Academy of Sciences has transferred responsibility for future editions to the United States Pharmacopeia (www.usp.org). The FCC is a compendium of standards that promote quality and safety of food additives such as preservatives, flavoring, coloring and nutrients. Developed following passage of the 1958 Food Additives amendment to the federal Food, Drug, and Cosmetic Act, to date, five editions have been published (1966, 1972, 1981, 1996, and 2003). As the time approached to develop the sixth edition of the FCC, it became clear that funds needed to develop the scientific content of the sixth edition could not be obtained. To assure continuity of this vital reference document, on August 23 the National Academy of Sciences entered into an agreement with the USP to develop and publish future editions of the FCC.
Until USP publishes the sixth edition, planned for February 2008, the IOM’s fifth edition and its supplement are effective and continue to be available form the National Academies Press."

[Courtesy of http://www.iom.edu/CMS/3788/4585.aspx]

European Pharmacopoeia (EP)

The European Pharmacopoeia is a listing of a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. The 2005 edition includes 1800 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks. It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described.

[Courtesy of http://en.wikipedia.org/wiki/European_Pharmacopoeia]

Japanese Pharmacopoeia (JP)

The Japanese Pharmacopoeia provides the official Japanese standard for the description and quality of drug substances and products.

The Japanese, United States and European Pharmacopoeias are the major pharmacopoeias in the world. They have established regular lines of communication and have set up a program that is working towards the harmonization of monographs and standards.

[Courtesy of http://www.rt-corp.com/products/c305.aspx]

On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a Convention, under the auspices of the Council of Europe, on the elaboration of a European Pharmacopoeia. The objectives are to harmonize specifications for medicinal substances which are of general interest to the peoples of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.
These objectives are attained by creating a European Pharmacopoeia made up of monographs which become official standards applicable in the territories of the Contracting States.
On 16 November 1989, a Protocol to the Convention was signed which enabled the European Community to accede to the Convention. The Protocol entered into force on 1 November 1992.

A total of 32 European countries are now party to the Convention:

The European Pharmacopoeia is drawn up by two bodies:

[Courtesy of http://europa.eu/scadplus/leg/en/lvb/l21161.htm]

Technical Association of the Pulp and Paper Industry (TAPPI)

The Technical Association of the Pulp and Paper Industry is the leading association for the worldwide pulp, paper, packaging, and converting industries and co-publisher of Paper360°. Through information exchange, trusted content, and networking opportunities, TAPPI helps members elevate their performance by providing solutions that lead to better, faster, and more cost effective ways of doing business.

Founded in 1915, TAPPI has grown into the world’s largest professional association serving the pulp, paper, converting and packaging industries. TAPPI’s members look to the association for information, education, and knowledge-sharing opportunities.

TAPPI’s Mission is to engage the people and resources of our Association in providing sound solutions to the workplace problems and opportunities that challenge our current and future members. And, TAPPI’s Vision is to make a significant positive difference in the professional lives of our members.

TAPPI serves four distinct segments of the global industry: pulp and paper technical, pulp and paper operations, converting and packaging, and suppliers and consultants. Recently, the Association has expanded its reach within the pulp and paper industry to the operations area, providing value throughout the production chain. At the same time, TAPPI remains committed to providing the vital forum that more technically focused scientists and engineers need and expect from TAPPI as they work to discover the innovative solutions our industry needs. TAPPI is committed to helping pulp and paper manufacturers improve their manufacturing operations, enrich their workforce, and shape our industry’s future.

TAPPI has served the converting and packaging industry for many years. Currently, the Association is working to build on its successes in both the corrugated packaging and the flexible packaging areas by focusing dedicated resources and building innovative new products and services to meet the specific needs of people in the converting and packaging industry.

Through TAPPI, suppliers and consultants working in the pulp, paper, packaging, and converting industry have unparalleled opportunities to contribute their technical expertise to the industry; to achieve their company’s objectives, and to develop their core competencies through professional development, education, and training.

For over 90 years, TAPPI has been a resource and a solution for the entire industry, helping members and countless individuals and companies throughout the global pulp, paper, packaging, and converting industry advance to a higher level of performance.

[Courtesy of http://www.answers.com/topic/tappi]

United States Pharmacopeia – National Formulary (USP-NF)

The United States Pharmacopeia–National Formulary is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding. The USP–NF is also widely used by manufacturers wishing to market therapeutic products worldwide. Meeting USP–NF standards is accepted globally as assurance of high quality.

[Courtesy of http://www.usp.org/USPNF/]