Application Finder
- 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.
- AN-S-376Fluoride in sodium fluoride gel for pharmaceutical use
Sodium fluoride gel for pharmaceutical use needs to comply with USP requirements. The actual monograph (USP 42) uses two different methods for the identification and the assay. Ion chromatography allows the analysis of these two parameters in one single determination. In the course of the USP monograph modernization, this ion chromatographic approach makes this type of analysis even easier.
- AN-S-379Fluoride in sodium fluoride tablets for pharmaceutical use
Sodium fluoride tablets for pharmaceutical use need to comply with U.S. Pharmacopeia (USP) requirements. Ion chromatography (IC) with suppressed conductivity detection has been approved by the USP as a validated method to quantify fluoride content in sodium fluoride tablets. In the course of the USP monograph modernization, using automated IC makes this type of analysis even easier.
- AN-S-380Monofluorophosphate and fluoride in sodium monofluorophosphate for pharmaceutical use
Ion chromatography (IC) with suppressed conductivity detection has been approved by the U.S. Pharmacopeia (USP) as a validated method to quantify the monofluorophosphate (MFP) content in sodium monofluorophosphate. This Application Note shows that all acceptance criteria for the USP Monograph «Sodium Monofluorophosphate» are fulfilled and the procedure was approved as a validated USP method.
- AN-S-397IC assay for sodium chloride in sodium chloride tablets for solution
As an alternative to titration, ion chromatography (IC) with suppressed conductivity detection has been approved by USP as validated method to quantify chloride content in NaCl tablets for solution or oral use.
- AN-S-398Phosphate in sodium and potassium phosphates compounded injections
An ion chromatography (IC) assay with suppressed conductivity detection is the standardized way to accurately quantify phosphate in phosphates compounded injections.
- AN-S-399IC assay for fluoride in sodium fluoride and acidulated phosphate topical solution
Anticavity pharmaceuticals like sodium fluoride and acidulated phosphate topical solution products require strict quality control. This Application Note outlines the fluoride IC assay as described in the USP Monograph Sodium Fluoride and Acidulated Phosphate Topical Solution.
- AN-S-400Assay of nitrite in sodium nitrite
In severe cases of cyanide poisoning, sodium nitrite is used along with sodium thiosulfate for treatment. This Application Note describes the nitrite ion chromatography assay with the Metrosep A Supp 4 column and suppressed conductivity detection. This column equivalency study was in cooperation with the USP according to the USP General Chapter <621>.
- AN-S-401Nitrite in duloxetine hydrochloride API
Nitrosamine presence in medicines, even at trace level poses high safety risks to patients (carcinogenic). Nitrosamine formation can be avoided by controlling and monitoring the nitrite concentration in pharmaceutical products and substances. This Application Note describes the analysis of nitrite in duloxetine hydrochloride with ion chromatography (IC).
- AN-S-402Nitrite in hydroxypropyl methylcellulose
Nitrosamine formation can be avoided by controlling the nitrite concentration in pharmaceutical products and processes. To monitor nitrosamine formation, sensitive analytical methods such as ion chromatography for the determination of nitrite in pharmaceutical products and substances are essential.
- AN-U-011N-acetylcysteine in a medication against sinusitis according to USP
Determination of N-acetylcysteine and phenylalanine in tablets against sinusitis by anion chromatography with UV/VIS detection according to USP.
- AN-U-027System suitability test for cefazolin in accordance with USP
Determination of cefazolin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics
- AN-U-028Salicylic acid impurity in aspirin tablets according to the USP method
Determination of salicylic acid and acetylsalicylic acid according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.
- AN-U-029Analysis of cloxacillin sodium in accordance with USP
Determination of cloxacillin sodium in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics
- AN-U-030System suitability test for amoxicillin in accordance with USP
Determination of amoxicillin in accordance with USP 28-NF 23 (Appendix 2) using RP chromatography and subsequent UV detection. Keyword: Antibiotics
- AN-U-033Assay of theophylline tablets according to the USP method
Determination of theophylline and theobromine according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.
- AN-U-034Chromatographic purity determination of ibuprofen according to USP
Determination of valerophenone and ibuprofen according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.
- AN-U-035Chromatographic purity determination of thiamine hydrochloride according to USP
Determination of thiamine hydrochloride according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.
- AN-U-036Assay determination of ranitidine HCl according to USP
Determination of ranitidine hydrochloride according to USP 28-NF 23 (second supplement) using RP chromatography with UV detection.
- AN-U-037System suitability test for penicillin G potassium in accordance with USP
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
- AN-U-043Sample determination of cefadroxil in accordance with USP
Determination of cefadroxil in accordance with USP 28-NF 23 (Supplement 2) using RP chromatography with UV detection. Keyword: Antibiotics
- AN-U-076Zinc Oxide Assay as per USP General Chapter <591>
Manufacturers and laboratories must use validated methods to determine the zinc content in skin care products and pharmaceutical supplements to meet strict quality standards set by the United States Pharmacopeia and National Formulary (USP-NF). USP-NF has updated the zinc monograph (General Chapter <591>, Zinc Determination) and replaced the existing identification procedure of titration with ion chromatography (IC). The analysis involves separating Zn using a Metrosep A Supp 10 column followed by post-column reaction using 4-(2-pyridylazo)resorcinol and detection at 530 nm.
