FAM ERP New Member Book.pdf

Applicability statements

Applicability statements should include the list of matrix(es) along with specific matrix types and range or limits of determination or detection. Applicability statements should address utility and limitations on use of method or other information.

[Applicable for determination of ….]

Caution Statements

List any statements of caution after the applicability section. Review all methods for potential hazards. Authors should automatically incorporate safety statements. Decisions regarding inclusion of caution statements should be practical; overuse will be self-defeating. Methods that create toxic, obnoxious or environmentally hazardous fumes and wastes should contain practical directions for disposal. Specify precautions and possible hazards in carrying out method, including safety information on equipment, techniques and practices, and safe handling of chemicals, acids, alkalies, microorganisms, and solvents.

Example:

Caution: Refer to the material safety data sheets for all chemicals prior to use. Use all appropriate personal protective equipment and follow good laboratory practices.

Performance Parameters

Include statistical data if the study provides sufficient information with regard to the reliability of the method.

All headings should be set in Alphabetical Order i.e., A. Principle, B. Apparatus, C. Reagents. Methods should be laid out in the following order:

Principle

Explains scientific premise on which the method is operates specifically the mechanism of the analysis. Explain the purpose of various steps or the basis of unfamiliar or unusual reactions. Include the scope and sensitivity of the method—its applicability to certain types of samples and its non-applicability, because of interference, solubility, or other reasons, to other types of samples. Methods are divided into several descriptive sections i.e., Apparatus, Reagents, Reagent Preparation, Standard Preparation, Sample Preparation, Extraction . The sections should include specific tions for necessary laboratory a paratus and eage t preparations. See also Definition of Terms and Explanatory Notes . NOTE: Official Methods will need to include InChi numbers and CAS numbers where appropriate.

Apparatus

Lists the equipment that requires assembly or that has specifications critical to the method performance. Describe equipment in terms of performance characteristics. List the necessary laboratory apparatus. For more information see “Definition of Terms and Explanatory Notes”

Apparatus should be set as in the following example:

(a) Ultra-HPLC (UHPLC) system —Nexera (Shimadzu, Kyoto, Japan) or equivalent LC system consisting of a dual pump syste , a sample injector unit, a degasser unit, and a column oven. (b) Triple-quadrupole mass spectrometer —Triple Quad 6500 (Sciex, Framingham, MA) or equivalent tan em MS (MS/MS) instrument. (c) Column —Kinetex C18 core- VKHOO ȝP î PP 3KHQRPHQH[ 7RUUDQFH &$ RU equivalent.

Reagents

Do not list common reagents which would ordinarily be expected to be available in a well- equipped analytical laboratory. Reagents without specifications are automatically reagent grade, conforming to the specifications of the American Chemical Society (ACS) when such specifications exist.

Reagents should follow the same format as in the above example under Apparatus.

Reagent Preparation, Standard Preparation, Sample Preparation, Extraction Sections

Use these sections for materials requiring directions for preparation, purification, or standardization. Standard compounds will often need specifications or a source of supply.

The sections should use the same style and format as in the above example under Apparatus.

Determination

If a method is fairly straightforward or consists only of a single major step, describe all operations under this heading. If the method is complex, however, divide the determinative section into several parts which may be characterized bye the type of operation performed. Be sure to identify all critical control points.

Calculations

Include calculations in a method for convenience to avoid the need for looking up factors and deriving equations, particularly when a series of multiple dilutions or aliquots are used at various steps in the method. Take particular care to ensure that there is no ambiguity with regard to the entries in the numerator and the denominator.