Wissen, was drin ist:
Pharmakopöen
Analytik gemäß Arzneibuch – fundiert, verlässlich, auf den Punkt gebracht
Arzneibuchmethoden gehören zu unserem Tagesgeschäft – und das merkt man. Ob Ph. Eur., USP/NF oder JP: Wir prüfen Ihre Produkte genau so, wie es die regulatorischen Vorgaben verlangen. Dabei achten wir nicht nur auf Genauigkeit, sondern auch auf Effizienz und klare Kommunikation.
Was analysieren wir? Alles, was dazugehört: Identität, Reinheit, Gehalt, Gleichförmigkeit, Freisetzung und mehr.
Neugierig geworden? Hier finden Sie eine Übersicht unserer Analysen gemäß Arzneibuch.
Materialprüfung
Glasgefäße
- Ph. Eur. 3.2.1
- USP/NF 〈660〉
Plastikgefäße
- Ph. Eur. 3.2.3
- Ph. Eur. 3.2.4
- Ph. Eur. 3.2.5
- Ph. Eur. 3.2.6
- USP/NF 〈661〉
- USP/NF 〈671〉
Gummiverschluß / Silicon Elastomere
- Ph. Eur. 3.2.9
- USP/NF 〈381〉
- Ph. Eur. 3.1.9
Tests auf Partikel und Aussehen der Lösung
Sichtbare Partikel
- Ph. Eur. 2.9.20. Particulate contamination: visible particles
- USP/NF 〈790〉 Visible Particulates in Injections
Nicht sichtbare Partikel
- Ph. Eur. 2.9.19. Particulate contamination: sub-visible particles
- USP/NF 〈788〉 Particulate Matter in Injections
Klarheit und Farbe der Lösung
- Ph. Eur. 2.2.1. Clarity and degree of opalescence of liquids
- Ph. Eur. 2.2.2. Degree of coloration of liquids
- USP/NF 〈630〉 Visual Comparison
- USP/NF 〈855〉 Nephelometry and Turbidimetry
Partikelverteilung
- Ph. Eur. 2.9.31. Particle size analysis by laser light diffraction
- USP/NF 〈429〉 Light Diffraction Measurement of Particle Size
Bioanalytik und Mikrobiologie
- Ph. Eur. 2.2.31 Electrophoresis
- Ph. Eur. 2.2.44 Total organic carbon in water for pharmaceutical use
- Ph. Eur. 2.2.47 Capillary electrophoresis
- Ph. Eur. 2.5.33 Total protein
- Ph. Eur. 2.6.7 Mycoplasmas
- Ph. Eur. 2.6.12 Microbiological examination of non-sterile products: microbial enumeration tests
- Ph. Eur. 2.6.13 Microbiological examination of non-sterile products: test for specified micro-organisms
- Ph. Eur. 2.6.14 Bacterial endotoxins
- Ph. Eur. 2.6.30 Monocyte-activation test
- Ph. Eur. 2.6.31 Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation
- Ph. Eur. 2.6.34 Host-cell protein assay
- Ph. Eur. 2.6.35 Quantification and characterisation of residual host-cell DNA
- Ph. Eur. 2.7.2 Microbiological assay of antibiotics
- Ph. Eur. 2.7.5 Assay of heparin
- Ph. Eur. 5.1.3 Efficacy of antimicrobial preservation
- Ph. Eur. 5.1.4 Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
- Ph. Eur. 5.1.8 Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation
- USP/NF 〈51〉 Antimicrobial Effectiveness Testing
- USP/NF 〈60〉 Microbiological Examination of Nonsterile Products Tests for Burkholderia Cepacia Complex
- USP/NF 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- USP/NF 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP/NF 〈81〉 Antibiotics—Microbial Assays
- USP/NF 〈85〉 Bacterial Endotoxins Test
- USP/NF 〈507〉 Protein Determination Procedures
- USP/NF 〈509〉 Residual DNA Testing
- USP/NF 〈643〉 Total Organic Carbon
- USP/NF 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- USP/NF 〈1104〉 Immunological Test Methods—Immunoblot Analysis
- USP/NF 〈1111〉 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
- USP/NF 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
- USP/NF 〈1127〉 Nucleic Acid-Based Techniques—Amplification
- USP/NF 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
Physikalisch-chemische Tests
Gehalt
- Ph. Eur. 2.5.1. Acid value
- Ph. Eur. 2.5.3. Hydroxyl value
- Ph. Eur. 2.5.6. Saponification value
- Ph. Eur. 2.5.11. Complexometric titrations
- Ph. Eur. 2.5.12. Water: semi-micro determination
- Ph. Eur. 2.5.32. Water: micro determination
- Ph. Eur. 2.5.29. Sulfur dioxide
- Ph. Eur. 2.5.30. Oxidising substances
- Ph. Eur. 2.5.33. Total Protein e. g. Bradford, Lowry
- USP/NF 〈921〉 Water Determination
- USP/NF 〈401〉 Fats and Fixed Oils
- USP/NF 〈525〉 Sulfur Dioxide
- USP/NF 〈507〉 Protein Determination Procedures e. g. Bradford, Lowry
Grenzwertprüfungen
- Ph. Eur. 2.4.3. Calcium
- Ph. Eur. 2.4.4. Chlorides
- Ph. Eur. 2.4.6. Magnesium
- Ph. Eur. 2.4.8. Heavy metals
- Ph. Eur. 2.4.9. Iron
- Ph. Eur. 2.4.13. Sulfates
- Ph. Eur. 2.4.14. Sulfated ash
- Ph. Eur. 2.4.16. Total ash
- Acidity or alkalinity
- reducing substances
- USP/NF 〈281〉 Residue on Ignition
- USP/NF 〈221〉 Chloride and Sulfate
- USP/NF 〈231〉 Heavy Metals
Titrationen
- Ph. Eur. 2.2.20. Potentiometric titration
- USP/NF 〈541〉 Titrimetry
- Ph. Eur. 2.5.11. Complexometric titrations
- Ph. Eur. 2.5.12. Water: semi-micro determination
- Ph. Eur. 2.5.32. Water: micro determination
- USP/NF 〈921〉 Water Determination
Viskosität
- Ph. Eur. 2.2.9. Capillary viscometer method
- Ph. Eur. 2.2.10. Viscosity - Rotating viscometer method
- USP/NF 〈1911〉 Rheometry
Sonstige
- Ph. Eur. 2.2.32. Loss on drying
- USP/NF 〈731〉 Loss on Drying
- Ph. Eur. 2.3.1. Identification reactions of ions and functional groups
- USP/NF 〈191〉 Identification Tests—General
- Ph. Eur. 2.9.1. Disintegration of tablets and capsules
- Ph. Eur. 2.9.2. Disintegration test for solid rectal and vaginal dosage forms
- USP/NF 〈701〉 Disintegration
- Ph. Eur. 2.2.5. Relative density
- USP/NF 〈841〉 Specific Gravity
- Ph. Eur. 2.2.6. Refractive index
- USP/NF 〈831〉 Refractive Index
- Ph. Eur. 2.9.8. Resistance to crushing of tablets
- USP/NF 〈1217〉 Tablet Breaking Force
- Ph. Eur. 2.2.7. Optical rotation
- USP/NF 〈781〉 Optical Rotation
- Ph. Eur. 2.8.4. Swelling index
- Ph. Eur. 2.2.35. Osmolality
- USP/NF 〈785〉 Osmolality and Osmolarity
- Ph. Eur. 2.9.39. Water-solid Interactions: determination of sorption-desorption isotherms and of water activity
- USP/NF 〈922〉 Water Activity
Freisetzung und Gleichförmigkeit
Freisetzung
- Ph. Eur. 2.9.3. Dissolution test for solid dosage forms
- Ph. Eur. 2.9.4. Dissolution test for patches
- Ph. Eur. 2.9.25. Dissolution test for medicated chewing gums
- Ph. Eur. 2.9.42. Dissolution test for lipophilic solid dosage forms
- Ph. Eur. 2.9.43. Apparent dissolution
- USP/NF 〈711〉 Dissolution
Gleichförmigkeit
- Ph. Eur. 2.9.5. Uniformity of mass of single-dose preparations
- Ph. Eur. 2.9.6. Uniformity of content of single-dose preparations
- Ph. Eur. 2.9.40. Uniformity of dosage units
- USP/NF 〈905〉 Uniformity of Dosage Units
ICP-MS / HPLC / GC
Gehalt, Identität und Grenzwertprüfungen
Beispiele
- Allgemein
- Ph. Eur. 2.2.27. Thin-layer chromatography
- Ph. Eur. 2.2.28. Gas chromatography
- Ph. Eur. 2.2.29. Liquid chromatography
- Ph. Eur. 2.2.30. Size-exclusion chromatography
- Ph. Eur. 2.2.46. Chromatographic separation techniques
- Ph. Eur. 2.2.47. Capillary electrophoresis
- Composition of fatty acids
- Ph. Eur. 2.4.22. Composition of fatty acids by gas chromatography
- USP/NF 〈401〉 Fats and Fixed Oils
- residual solvents
- Ph. Eur. 2.4.24. Identification and control of residual solvents
- USP/NF 〈467〉 Residual Solvents
- USP/NF 〈1467〉 Residual Solvents—Verification Of Compendial Procedures And Validation Of Alternative Procedures
- elemental impurities / Screening
- Ph. Eur. 2.4.20. Determination of elemental impurities
- USP/NF 〈232〉 Elemental Impurities—Limits
- N-Nitrosamine
- untargeted screening
- Aminosäuren
- Ph. Eur. 2.2.56. Amino acid analysis
- ethylene oxide and dioxan
- Ph. Eur. 2.4.25. Ethylene oxide and dioxan
- USP/NF 〈228〉 Ethylene Oxide and Dioxane
- USP/NF 〈469〉 Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
- Und noch vieles mehr
Identitätsprüfung
- Ph. Eur. 2.2.24. Absorption Spectrophotometry, Infrared
- USP/NF 〈197〉 Spectroscopic Identification Tests
Und das ist längst nicht alles
Wir analysieren noch vieles mehr – von gängigen Arzneibuchmethoden bis hin zu individuellen Sonderanforderungen. Die hier gezeigte Übersicht ist nur ein erster Einblick in unser Leistungsspektrum.
Sie haben eine konkrete Fragestellung?
Sprechen Sie uns an – wir finden die passende Lösung.
