Application Finder

Pharmaceutical analysis guarantees drug safety by providing information on the identity, content, quality, purity, and stability of pharmaceutical products using analytical chemistry. Ion chromatography (IC) offers a broad range of pharmacopeia-compliant applications for quality control, monitoring, and improving drug manufacturing.As a very accurate and versatile technique, IC meets the requirements of many pharmaceutical applications. IC is a USP-accepted standard method for the determination of active pharmaceutical ingredients (APIs), excipients, impurities,pharmaceutical solutions as well as pharmaceutical starting materials, finished pharmaceutical products (FPPs) and even body fluids.This poster describes some typical examples.

Sulfathiazoles are sulfonamides with antibiotic effect that occur in various polymorphous forms and that are often used in veterinary medicine. This Application Note shows the differentiation between commercial and sulfathiazole form I using near-infrared spectroscopy (NIRS) with the help of the overtone frequencies of N-H stretching vibration. Form I is the least stable polymorphous form. Crystallization and polymorphism must be monitored as part of quality controls. In this, NIRS is considerably more rapid and more reliable than conventional laboratory methods.

Gentamicin is an aminoglycoside antibiotic and is composed of a number of related gentamicins. It is applied for several types of infections. For the determination of the major components, USP asks for chromatographic separation with pulsed amperometric detection using a gold working electrode. A post-column addition of NaOH is performed prior to the detection.

Determination of ampicillin in raw and pure products through potentiometric titration with Hg(II) using the combined Au electrode. Keyword: Antibiotics

Determination of total penicillin content through potentiometric titration with Hg(II) using the combined Au electrode. Keyword: Antibiotics

Determination of phenylglycine through nonaqueous potentiometric titration with sodium methylate using a special combined glass electrode. Keyword: Antibiotics

The purity of sulfanilamide was determined by means of automatic potentiometric titration using sodium nitrite as the titrant. The solution was spiked with potassium bromide, because bromide ions catalyze diazotization titration.

Penicillin and its related antibiotics are used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections, meningitis, etc. It may also be used to prevent group B streptococcal infection in newborns. The β-lactam ring of penicillin binds to the enzyme DD- transpeptidase, which prevents the formation of cross links during cell wall formation of new bacterial cell, i.e., the division of bacterial cells. USP<425> describes a back-titration method to determine the assay of pharmacopeial penicillin antibiotic drugs and their dosage forms by iodometric titration. The method is illustrated by determining the aminopenicillin content in an ampicillin capsule.

Sulfonamides are drugs used to treat allergies and cough. They also have some antifungal and antimalarial activities. USP<451> describes nitrite titration method for the determination of numerous pharmacopeial sulfonamide drugs and their dosage forms as well as of other pharmacopeial drugs with, for example, hydrazide (e.g., in isoniazid) and amine ester groups (e.g., in procaine) or amide derivatives of amino acids.Here, for illustrating the analysis of the latter, the assay of the diagnostic agent aminohippuric acid is described.

Determination of cefazolin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of cloxacillin sodium in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of amoxicillin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of penicillin G potassium and 2-phenyl acetamide in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics

Determination of cefadroxil in accordance with USP 28-NF 23 (Supplement 2) using RP chromatography with UV detection. Keyword: Antibiotics

Ion chromatography is used as a high-performance analysis method in numerous applications. For complex analysis tasks, alternative detectors such as the amperometric detector or the UV/VIS detector are often also used in addition to the conductivity detector. This article describes the areas of utilization of the amperometric detector. Catchword: Antibiotics

The pharmaceutical industry is very likely more comprehensively regulated that any other branch of industry. It therefore requires analytic methods that meet the requirements of regulations while at the same time being practical. This applies in particular for large sample quantities, such as are encountered with incoming goods inspections, for example. It is here that particularly rapid and simple analysis methods are called for which make routine analyses simpler and more efficient. This White Paper describes some of the most important regulations in the pharmaceutical analysis and shows how Vis-NIR spectroscopy can solve analytic problems in the pharmaceutical industry in accordance with regulations.

Ion chromatography is a flexible technique with a large selection of intended uses in the pharmaceutical industry. – A few development trends and the latest advances are displayed here.