Test method conformance

The measurement techniques were chosen to parallel, as much as possible, similar ones used for coal. Most test methods conformed to ASTM procedures where available or adaptable to d-RDF. The sampling and analysis procedures for each property measurement are reported elsewhere (9). 

Specific test methods conforming to military standards are used for Chemical Warfare Agents (CW Agents). Therefore, class 595 has been designated for these CW Agents, but is not based on functional groups. CW Agents can be classified in many different ways. There are, for example, volatile substances, which mainly... 

Note 5—Ramsbottom coke furnaces now in use can have dimensional differences from those given in 6.4 however, it is essential that new furnaces obtained after the adoption of this test method conform to the requirements outlined in 6.4. A description of one type of furnace ndiich has been found to be satisfactory is given in Appendix XI. 

The pubHcations detailing standards (5—8) generally include both specifications and methods of analysis for the substances. The estabHshment of standards of quaHty for chemicals of any kind presupposes the abiHty to set numerical limits on physical properties, allowable impurities, and strength, and to provide the test methods by which conformity to the requirements may be demonstrated. Tests are considered appHcable only to the specific requirements for which they were written. Modification of a requirement, especially if the change is toward a higher level of purity, often necessitates revision of the test to ensure the test s vaHdity. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

Specifications and Standards Test Methods. Pood-grade HPC products are manufactured for use in food and conform to the specifications for HPC set forth in CPR 21, Section 172.870. Pood grades of HPC also conform to the specifications for HPC as Usted in the current edition of the Food Chemicals Codex. 

Stippler E. Development of BCS-conform Dissolution Testing Methods. Dissertation thesis, University of Frankfurt, 2004. 

The wavelength-dispersive x-ray spectroscopy method (ASTM D6376) provides a rapid means of measuring metallic elements in coke and provides a guide for determining conformance to material specifications. A benefit of this method is that the sulfur content can also be used to evaluate potential formation of sulfur oxides, a source of atmospheric pollution. This test method specifically determines sodium, aluminum, silicon, sulfur, calcium, titanium, vanadium, manganese, iron, and nickel. 

For testing methods it depends on factors such as the requirements of the test method, the requirements of the customer, the existence of narrow limits on which decisions or conformance to a specification are based. 

Select the engine coolant or antirust with care to ensure adequate corrosion protection. Use only those products conforming to recognized standards such as ASTM D 3306 for engine coolant. Additionally, if your vehicle engine contains major cast aluminum components, be certain the engine coolant meets the heat rejection corrosion limits in ASTM specification D 3306 as determined by ASTM Test Method for Corrosion of Cast Aluminum Alloys in Engine Coolants Under Heat-Transfer Conditions (D 4340). 

The chemical and physical requirements of the fuel shall conform to those listed in Table I, when tested in accordance with the applicable tests. Requirements contained herein are absolute and are not subject to correction for tolerance of test methods. However, if multiple determinations are made, average results shall be used... 

Test methods. Tests as specified in 3.2 to determine conformance to chemical and physical requirements shall be conducted in accordance with Federal Test Method Standard No 791 or ASTM standards, using applicable methods as listed in Table I, except for the following... 

Dissolve 5.00g of the specimen in 76g of toluene and 19g of ethanol conforming to Spec O—E—760. Determine the viscosity at 25° according to Method 305 of Federal Test Method Standard No 791, except that the results in cent stokes should be converted to centipoises as follows ... 

Stoddard solvent—mineral spirits with a minimum flash point of 37.8°C (100°F), relatively low odor level, and other properties conforming to Stoddard solvent specifications, as described in test method ASTM D 484. Though formulated to meet dry cleaning requirements, Stoddard solvents are widely used wherever this type of mineral spirits is suitable. 

Commitment to use the same SOPs and test methods employed in the approved application written certification from the testing laboratory stating that it is in conformance to CGMPs and a full description of the testing to be performed by the testing laboratory CBE with full description and certification... 

Another objective of this review have been to provide the reader with explicit laboratory methods for preparing agents/intermediates of interest, testing methods used to assay material efficacy, and analytical data for strucmral conformation. 

Near-infrared spectroscopy was proposed as an alternative to several compendial test methods. As an example, ampicillin trihydrate was used to demonstrate that in total, eight quality criteria could be checked and its conformity index calculated.Additional che-mometrics for quality control were developed by the same group. Their strategy was used to distinguish differences in mean particle size of various lactose samples and to study the effectiveness of a blending process for homogenous mixture preparation. 

In the drug-discovery field, chemists can use NIR to monitor the progress of reactions. Hearn and co-workers reported a NIR method to monitor the preparation of compounds for screening as antituberculosis drugs. The reaction of isonicotinic acid hydrazide (INH) with carbonyl compounds in the preparation of Schiff bases was followed. Forbes, Persinger, and Smith " described a NIR conformance test method to assay and identify two chemical intermediates used in the manufacture of Loracarbef, a carbacephalosporin. 

Scope of accreditation comes to refer to a detailed list of individual tests in conformity with accreditation references and reflects the situation of a given laboratory at the time when an audit is conducted. Each test is specific to a product or type of products analyzed, to a set of parameters measured, to a range of measurement applicable to this particular test, and to test methods used by a given laboratory for this particular test. Product as a concept could also be expressed as a range of product. Accreditation for a test method could drown methods considered as equivalent if they are established via identical methodology-... 

Laboratories which conform to standards NBN-EN 45001 (Paragraph 5.4.1., 5.4.2., 6.2 and 6.3.) and NBN-EN-ISO-CEI 17025 (Paragraph 5.4.5.) standards should use validated methods for testing, methods which produce reliable results part of the results validation procedure includes an obligation to demonstrate the capacity to carry out this procedure. 

Herbal medicines with constituents of known therapeutic activity are often standardized (i.e. adjusted to a defined content of such constituents). The methods used to achieve such standardization should be documented. If another substance is added for these purposes, it is necessary to specify, as a range, the quantity that may be added. Blending different batches of a specific herbal material (e.g. before extraction) or by mixing different lots of similar herbal preparations may also be acceptable. Records should be maintained to ensure traceability. The blending process should be adequately controlled and documented and the blended batch should be tested for conformity with established specifications where appropriate. 

Current FDA guidelines require that methods filed in the NDA be used. Compendial methods and procedures do not have to be used for quality testing however, official drug products must conform to appropriate compendial standards. Initially, when the FDA approves a new drug product, there are no official compendial methods. Typically, the USP and other pharmacopeias will approach the manufacturer and request the testing methods that will be used so that they can be incorporated into the pharmacopeia. If provided, the testing methods become the official compendial methods. Otherwise, the USP will develop its own methods. 

---