british pharmacopoeia 2010 free download pdf

British Pharopoeia 2010 Full Chapter URL

Selection of an excipient that is not of compendial grade requires justification in the regulatory submission.

The role of the individual spectroscopic techniques in the monographs of these is summarized as follows.

UV spectrophotometry has a double role in modern pharmacopoeias.

The less important role is the identification of bulk drugs and the active ingredients in their formulations.

More important is its use for their assay, that is, determination of the active ingredient content (requirement usually minimum 9899 and 5 to 10 of the labeled amount, respectively).

Although it is a nonspecific method, and for this reason its importance is slowly decreasing, its share among the assay methods is still around 10.

Outdated color reactions are disappearing from both the qualitative and quantitative analyses.

The most frequently appearing method in the various monographs for assay and purity control purposes is HPLC.

It has to be mentioned that in the overwhelming majority of cases the detector is an UV spectrophotometer.

The most important field of application of IR spectroscopy in pharmacopoeias is the identification of drug materials by comparing their spectra with those of reference standards using mainly the potassium bromide pellet technique.

In some cases, the reason for obtaining not completely identical spectra can be polymorphism.

If this is known not to affect the therapeutic value of the drug, the test sample and reference standard are dissolved in the same volatile solvent, and after evaporation of the solvent the spectra are compared again.

Optical rotatory power (measured usually at the sodium D line at 589 nm) is among the physical constants determined in the case of chiral drugs administered as the pure enantiomer, with circular dichroism spectroscopy providing an enhanced characterization of chiral drugs.

NMR spectroscopy is used in pharmacopoeias for identification purposes in a very limited number of cases only.

Although the most generally used limit test for heavy metals is still based on their classical test-tube reaction with sulfide ion, atomic absorption spectrometry is increasingly used if the aim is the selective determination of traces (usually 220 ppm) of individual metals, for example, zinc in acetylcysteine; iron in ascorbic acid; palladium in acitrecin; cadmium, chromium, lead, mercury, nickel, and zinc in ferrous fumarate; and so on.

Atomic emission spectrometry (AES) and inductively coupled plasma atomic emission spectrometry (ICP-AES) are very seldom used, for example, for the determination of potassium impurity in sodium chloride and boron (maximum 1 ppm) in dalteparin sodium.

British Pharopoeia 2010 Full Chapter URL

View chapter Purchase book Read full chapter URL: Regulatory guidelines for the development of a biotechnology drug product Mark J.

The discussion should include the purpose of the excipients in the formulation as was called out in the composition table, what function that excipient serves, and why that particular excipient was selected to fill that role.

Excipients should be selected that are of compendial grade, or multi-compendial grade, if available.

The use of multi-compendial grade excipients will facilitate the regulatory submission in many countries.

The compendial grade selection criteria should include quality requirements.

The testing of compendial grade excipient should include the evaluation of attributes of that excipient required for proper function in the current formulation.

If not, additional testing of the excipient over and above the compendial testing requirements should be considered.

British Pharmacopoeia 2010 Free Download Pdf