Specific identity

Answer this question only after you have completed the rest of the report. The specific identity of the toxic chemical being reported in Part III, Sections 1.2 and 1.3, may be designated as trade secret. If you are making a trade secret claim, mark yes" and proceed to Section 1.2. Only check "Yes" if it is your manufacturing, processing, or use of the chemical that is a trade secret. (See page 1 of these instructions for specific information on trade secrecy claims.) ff you checked "no," proceed to Section 1.3 do not answer Section 1.2. 

Specific identity of a toxic chemical to be a trade secret, the notice to your customer(s) must contain a generic chemical name that Is descriptive of the structure of that toxic chemical. For example, decabromodiphenyl oxide could be described as a halogenated aromatic. 

For drug substances and drug products, applications for enantiomers and racemates should include a stereochemically specific identity test and/or a stereochemically selective assay. The choice of control tests should be based on the method of manufacture and stability characteristics and, in the case of the finished product, its composition. 

At least one test shall be conducted to verify the identity of each component of a drug product. Specific identity tests, if they exist, shall be used. 

Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the... 

The periodic system of the elements is not a human invention. This ordering principle is rooted in the fundamental secrets of nature. Each element has its determined place and its specific identity. 

Failure to have testing and release of drug product for distribution for determination of satisfactory conformance to the final specifications/identity and strength of each active ingredient prior to release. 

The final product specifications must contain a specific identity test. The full set of physical properties and physical constants that are characteristic of the substance must be measured and their appropriate values documented. And, very importantly, the purity of the final product must be demonstrated by a suitable chromatographic method. That chromatographic method must be able to measure the presence of impurities at concentrations of hundreds of a percent in order to be appropriate or acceptable for this purpose. Impurities present in the final product must be characterized. Those impurities which occur in final product at greater than 0.1% must be identified and tested for their biological properties, including toxicity, mutagenecity, etc. Ordinarily, impurities present in concentrations of 0.01 to 0.1% can be recorded as unidentified impurities, and impurities which occur at concentrations less than 0.01% are ordinarily just noted. 

Leaving the spectator ions out of a net ionic equation does not imply that their presence is irrelevant. Certainly, if a reaction occurs by mixing a solution of Pb2+ ions with a solution of I- ions, then those solutions must also contain additional ions to balance the charge in each The Pb2+ solution must contain an anion, and the 1 solution must contain a cation. Leaving these other ions out of the net ionic equation merely implies that the specific identity of the spectator ions is not important any nonreactive ions could fill the same role. 

Oligonucleotides are nucleic acid polymers. Each nucleic acid is assembled from a sugar, a nitrogenous heterocyclic base, and a phosphate. The specific identity of the sugar and base determines the type of nucleic acid, which in turn determines the structure and function of the oligonucleotide. 

Photoconductivity in a solid is defined as an increase of conductivity caused by radiation. The phenomenon of photoconductivity involves the processes of absorption of radiation, photogeneration of charge carriers, their separation, diffusion and drift in an applied electric field, their temporary immobilization at sites known as trapping rites, release from traps and finally their recombination. The phenomenological relationships covering all these processes were primarily developed in connection with the study of crystalline covalent solids which dominated the early scientific literature on photoconductivity. Concurrent with the basic understanding of the phenomena was the development of several experimental techniques to study the fundamental processes and the specific identity of the defects and impurities that control these processes. 

The two stable isotopes of carbon do not always occur in all natural samples in their usual ratio. In addition to the vaying ratios detected in interstellar molecules, certain meteoritic samples reveal a deficiency and some an excess of the 13C/12C ratio in comparison with the solar value. Because carbon possesses only two stable isotopes, it is a matter of semantics to assert which isotope is varying in samples thathave different isotope ratios. Saying this sample is 12C-rich says no more or less than saying this sample is 13 C-poor. Only elements having more isotopes than two can support more specific identities for the varying isotope. 

List all reagents, solvents, and auxiliary materials and a statement of the quality of each material (i.e., USP, NF, ACS, Technical). Describe the specifications and tests used to accept each batch of material. A specific identity test should be included. The need for additional testing depends on the role of the material used in the preparation or isolation of the drug substance. 

Specific Identity Tests. At least one specific identity test that is capable of distinguishing the drug substance from related compounds must be included. Spectrometric tests are usually used, such as ultraviolet, infrared, nuclear magnetic resonance, and mass spectroscopy. Retention times or factors derived from thin-layer, gas-liquid, and HPLC are also used as identification tests to verify a more specific spectral identity test. 

C. Specific aminoacyl tRNA s3mthetases recognize specific identity elements of tRNA and bind the appropriate amino acid to the tRNA. 

Many chiral compounds are known by the chemist to be racemic because of the lack of stereoselective influences on the synthesis or to be enantiopure because of natural origin. Such knowledge, while based on a sound technical foundation, may not be suitable for regulatory purposes. For example, the commercial availability of a racemate or the "opposite" enantiomer may make its substitution for the approved component conceivable. Therefore, it may be necessary to bring other factors (e.g synthetic feasibility or commercial sources) into consideration to establish whether a stereochemically specific identity test is necessary. 

Few drugs make use of X-ray powder diffraction as a regulatory test. However, this method has a unique advantage as a stereochemically specific identity test for chiral drugs. The crystal structure, and therefore the powder diffraction pattern, are necessarily different between the racemate and the enantiomer, except in the case of a racemic conglomerate. Furthermore, published reference data are readily available. In combination with the invariance of the d-spadng measurements, this msy make X-ray diffraction more attractive to the regulatory scientist. 

Finally, incoming components (e.g., raw materials) used to manufacture clinical supplies must be tested for identity using a specific identity test (if available). Specifications should be established and confirmed for each lot of components, drug product containers, and closures received (21 CFR 211.84 and 21 CFR 211.94), and all other provisions of 21 CFR Part 211, Subpart E, Control of Components and Drug Product Containers and Closures not noted in this section also apply to clinical supply manufacturing operations. 

In the absence of bias errors, the errors in the real and imaginary impedance are uncorrelated and the variances of the real and imaginary parts of the complex impedance are equal. Some specific identities are given in Table 21.1. 

The Burchfield colour reaction test is used to confirm the specific identity of a range of elastomers. The test results in colour changes before and after heating the test mixture (Braun, 1986). 

Opposition the organic farming sector is established with a specific identity by a diverse coalition of farmers and non-farmers. 

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