Приложения
- AN-C-146Bethanechol and HPTA (2-hydroxy-propyl-trimethyl ammonium) besides sodium and calcium (Metrosep C 6 - 250/4.0)
Bethanechol is a pharmaceutical compound which is used to treat urinary retention. This API (active pharmaceutical ingredient) can be determined by cation chromatography with direct conductivity detection. A good separation is achieved between bethanechol and its degradation product 2-hydroxy-propyl-trimethyl ammonium (HPTA) and the standard cations. Peak shape and resolution meet the USP requirements for bethanechol.
- AN-C-183Potassium in potassium bicarbonate effervescent tablets for oral solution
Within the scope of the USP monograph modernization, potassium is determined in potassium bicarbonate effervescent tablets for oral suspension applying cation chromatography with direct conductivity detection. The separation is performed on a Metrosep C 6 - 150/4.0 column (L76). All acceptance criteria are fulfilled.
- AN-C-184Potassium and sodium bicarbonates and citric acid effervescent tablets for oral solution
As an alternative to flame photometry, ion chromatography with non-suppressed conductivity detection has been approved by the USP as a validated method to quantify potassium and sodium content in potassium and sodium bicarbonates and citric acid effervescent tablets for oral solution. The present IC method has been validated according to USP General Chapter <621>.
- AN-C-185Potassium in potassium bicarbonate and potassium chloride effervescent tablets for oral solution
As an alternative to flame photometry, ion chromatography with non-suppressed conductivity detection has been approved by the USP as a validated method to quantify potassium content in potassium bicarbonate and potassium chloride effervescent tablets for oral solution. The Metrosep C 6 - 150/4.0 column (L76) provides the required separation of potassium and magnesium. The present IC method has been validated according to USP General Chapter <621>.
- AN-C-197Potassium assay in potassium citrate and citric acid oral solution
Potassium citrate and citric acid oral solutions act as systemic alkalizers. Potassium assays, validated per USP <621> and <1225>, use IC with L76 cation-exchange columns.
- AN-C-198Calcium acetate assay in calcium acetate capsules
The assay of calcium acetate, often used as a phosphate binder for dialysis patients, can be performed with ion chromatography (IC) as per USP <621> and <1225>.
- AN-CS-021Sodium in sodium bicarbonate and sodium phosphates compounded injections
Compounded injections of sodium bicarbonate are sterile solutions for correcting metabolic acidosis and other conditions requiring systemic alkalinization. Compounded injections of sodium phosphates serve as a phosphate source to either prevent or correct hypophosphatemia in patients with restricted oral intake. Ion chromatography (IC) with suppressed conductivity detection is the standardized way to accurately quantify sodium in these solutions.
- AN-S-286Sulfate and sulfamate analysis in Topiramate as per USP 33 - NF 28 Suppl. 1
Topiramate is an antiepilepsy drug. According to USP Topiramate tablets have to be tested for impurities. The determination of sulfate and sulfamate is mentioned under 'Specific Tests'. The isocratic method applies a column eluent combination primarily used for non-suppressed IC. But as sulfamate shows a negative peak under theses conditions the use of suppression is advantageous.
- AN-S-373Chloride in potassium bicarbonate and potassium chloride effervescent tablets for oral solution
Potassium chloride and potassium bicarbonate effervescent tablets are used to prevent potassium deficiency. Pharmaceutical manufacturers and labs adhere to strict quality regulations using USP-NF monographs. Ion chromatography with suppressed conductivity detection, utilizing the Metrosep A Supp 16 - 100/4.0 (L91) column, is approved by the USP to quantify chloride content in these tablets, following validation per USP General Chapter <621>.
- AN-S-375Fluoride in sodium fluoride for pharmaceutical use
Dental care products often contain sodium fluoride as an active ingredient. Manufacturers use the United States Pharmacopeia and National Formulary (USP-NF) Monograph «Sodium Fluoride» to quantify sodium fluoride and its anionic contaminants chloride and acetate in these products. The validated USP method proposes ion chromatography (IC) with suppressed conductivity detection to carry out the fluoride assay as well as the impurity determination in a single chromatogram.