Preparation of a specification

A good starting point is always the supplier s own specification, which can be expanded to include requirements specific to the required end use (for example particle size for powdered drink ingredients). 

The specification must be discussed and agreed individually with all potential suppliers, who must be provided with a copy of the final document. 

Although the preparation of the specification appeal s to be a straightforward process there are pitfalls that must be considered. 

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Note The man-hours listed in this table included collection of needed physical and other data and preparation of a specification or summary of the requirements. 

Where some hazard has been noted during the preparation of a specific compound, but without it being possible to identify a specific cause, an entry for that compound states Preparative hazard , and back-refers to the reactants involved in the preparation. 

RIA for hydromorphone and hydrocodone are fairly sensitive in the nanogram per millilitre range but essentially require the preparation of a specific antibody. The laid-out RIA method is quite capable of estimating the above drugs within a range of 2.5-20 ng ml 1 using standard 100 pi plasma sample only. 

The yields of these thermal processes are low, however, especially if they are employed for the preparation of a specific target molecule. For example, the pyrolysis of l,l-dichloro-2,2-dimethyl-cyclopropane furnishes a product mixture (total yield 63 %) which contains the diene XVI in 24 % yield only. 

This chapter aims to highlight the new catalytic methods that have been reported since 1992, An organization based on aldol type has been selected to facilitate chemists in easily identifying and selecting the transform and accompanying method towards the preparation of a specific target. As a testimony to the advances in this area, it is interesting to note how little overlap exists with those notable methods discussed in the first edition of Catalytic Asymmetric Synthesis [3a]. 

Write an equation, using the appropriate Grignard reagent, for the preparation of a specific deuterium-labeled hydrocarbon. 

Although it is always possible, once the formula of a specific POM is known, to write an equation analogous to Eq. (1) describing its formation, this is often not the appropriate synthetic procedure. In addition to variation of counter-cation, ionic strength and pH in aqueous media, syntheses may be carried out in non-aqueous solvents, via hydro- or solventothermal methods, and by solid state reactions. The starting material may even be a pre-formed stable or metastable POM this is especially the case for tungstates. While in some cases the preparation of a specific POM may be rationally designed, in the majority of systems the synthesis has to be described simply as "self assembly."... 

The preparation of a specific cuvet was required for the in situ IR spectroscopical observation of the gas-phase formed by decomposition of MTS (Fig. 3). 

Of all the reaction parameters involved in a heterogeneously catalyzed process, the selection of the catalyst is probably the most critical in determining the outcome of a particular reaction. The chapters in this section provide the reader with the information needed to make the selection of the catalyst more efficient. Most of the catalysts used for synthetic reactions are composed of the catalytically active species dispersed on a supposedly inert support material. The nature of the support can influence both catalyst stability and activity. It can also define the procedure best applicable for the preparation of a specific catalyst. Because of this, the commonly used supports are discussed in Chapter 9 to provide the background needed in the discussion of supported catalysts presented in the following chapters. 

In addition to being used in the whole-cell systems, n-hydantoinases are also commercially available as purified or partially purified enzymes in both free and immobihzed forms. A chemist can easily test tliese enzymes for preparation of a specific target amino acid, and scale up the process to produce large-quantity materials. Boehringer Mannheim offers two types of immobilized n-hydantoinases, D-Hydl and D-Hyd2, in both research and bulk quantities. The enzymes are cloned from thermophilic microorganisms and expressed and overproduced... 

Using hybrid arrest-translation procedures, we have identified a 23 kDa polypeptide which is coded for by clone 24 of class II. One of the dr-proteins has an approximate molecular weight of 23 kDa however, its identity with this peptide must await the preparation of a specific antibody. 

Enolate anions [1, 688, before references]. House and Trost12 developed a method for the preparation of a specific enolate anion by treatment of an enol acetate with methyllithium. 

Cold kits are prepacked sets of sterile ingredients designed for the preparation of a specific radiopharmaceutical. Kits are fully tested to verify the specific characteristics, which are guaranteed by the producer. 

As we have outlined in the preceding discussion, the presence of different metal ions leads to strong differences in the final heating temperature for obtaining a single perovskite phase. Consequently, comparison of the performance of different preparation methods is possible only when data are available concerning the preparation of a specific mixed oxide by different methods. Unfortunately, scarce examples exist in the literature in this respect. In the following, some of these will be discussed. 

Since tetraethynylethenes represent a repeat unit in more than one two-dimensional carbon network including 45 and 46 (Fig. 13-1) [1] the preparation of a specific network cannot be accomplished by simple oxidative polymerization of 20, but rather requires a more characteristic macrocydic precursor as starting material. Macrocyclic precursors to extended carbon sheets are perethynylated dehydroannulenes [56] and expanded radialenes, novel carbon-rich materials with interesting and unusual structures and functions. 

Oripov et al. 199) reported on some reactions of 3-hydroxy- and 3-di-methylaminoformylidenepyrrolo[2,l-h]quinazoline derivatives. Karimov et al. 200,201) reported on the synthesis of methoxy- and oxy-substituted deoxy-vasicinones and deoxyvasicines. Some compounds derived from deoxyvasicinone showed fungicidal activity (202). The preparation of a specific antibody to deoxyvasicinone (33) for the immunoassay of A -pyrroline has been described by Sakamoto and Samejima 203). 

A useful synthesis of copropotphyrin III and related compounds has now been achieved by modification of protoporphyrin IX the key reaction in this process is the terminal oxidation of the vinyl residues by thaliium(UI) trifluoroacetate (Scheme 6) this has now been utilized for the preparation of a specifically C-labeled coproporphyrin III required for biosynthetic studies. Further adaptation of this process has allowed the preparation of a range of other intermediates and analogs between copro- and protoporphyrin, including hardero-, pempto-, and chlorocruoroporphyrin and their isomers, as well as dihydroprotoporphyrin. ... 

Preparation of a specific life-cycle analysis for all investigated produets or processes according to the rules of ISO 14040 ff ... 

The preparation of a specific isotope, of an isotopically modified (i.e., mixture of labeled and unlabeled), isotopically substituted, or even site-specifically labeled compound is often mandatory in analytical applications. 

Because alkane chlorinations usually yield a complex mixture of products, they are not useful as synthetic methods when the goal is preparation of a specific alkyl chloride. 

Thus, SOPs and WIs comprise general actions and operations that apply to groups of products or equipment. The preparation of a specific medicine will be described in a Preparation Instruction (PI) (see Sect. 33.4), while maintenance of equipment is laid down in Operating Instructions. SOPs are not suitable for the recording of control data. When the activities described in SOPs or instructions produce results or other data, for example results of audits and investigations or data... 

A BPI is developed for a given batch size or a range of batch sizes of a standardised preparation. The formulation has been investigated in advance and the method of preparation has been validated. This means that data are collected and reviewed beforehand to ensure that each batch subsequently prepared will possess the required quality. The preparation method as described in the BPI is therefore only valid for the specified minimum and maximum batch size. The selected batch range depends on the equipment and materials used. Automated preparation documentation systems calculate the quantities to be processed when the batch size is adjusted. In the manual mode, for each batch size within the batch range a separate BPI has to be created. Before the preparation of a specific product is started, whether for the first time or after a change, the responsible pharmacist authorises the BPI and subsequently it is released for use. 

The composition and preparation method are usually drafted directly on the document shortly before the actual preparation starts. It may be possible to refer to a procedure describing a general preparation method. If available, referral can be made to a relevant procedure for the preparation of a specific pharmaceutical form. 

Using this approach, the preparation of a specification iterates repeatedly tlirough tlie following activities ... 

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