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Pharmacopoeial Testing
Pharmacopoeial Testing – Precise, Reliable, to the Point
Pharmacopoeial methods are part of our daily routine – and it shows. Whether Ph. Eur. USP/NF, or JP: we test your products in full compliance with regulatory requirements. Our Focus? Accuracy, efficiency, and clear communication.
What do we test? Everything that matters: identity, purity, content, uniformity, dissolution, and more.
Curious? Explore our range of pharmacopoeial testing services.
Packing Materials Testing
Glass containers
- Ph. Eur. 3.2.1
- USP/NF 〈660〉
Plastic containers
- 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〉
Rubber Seals / Silicon Elastomers
- Ph. Eur. 3.2.9
- USP/NF 〈381〉
- Ph. Eur. 3.1.9
Particulate Matters und Appearance of Solution
Visible particles
- Ph. Eur. 2.9.20. Particulate contamination: visible particles
- USP/NF 〈790〉 Visible Particulates in Injections
sub-visible particles
- Ph. Eur. 2.9.19. Particulate contamination: sub-visible particles
- USP/NF 〈788〉 Particulate Matter in Injections
Clarity and Color of solution
- 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
Particle size distribution
- Ph. Eur. 2.9.31. Particle size analysis by laser light diffraction
- USP/NF 〈429〉 Light Diffraction Measurement of Particle Size
Bioanalytical Services und Microbiology
- 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)
Physicochemical analyses
Assay
- 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
Limit tests
- 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
Titrations
- 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
Viscosity
- Ph. Eur. 2.2.9. Capillary viscometer method
- Ph. Eur. 2.2.10. Viscosity - Rotating viscometer method
- USP/NF 〈1911〉 Rheometry
others 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
Dissolution and uniformity
Dissolution
- 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
Uniformity
- 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
Assay, identity and limit tests
Examples
- General
- 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-Nitrosamines
- untargeted screening
- Amino Acids
- 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
- And much more
Tests for identity
- Ph. Eur. 2.2.24. Absorption Spectrophotometry, Infrared
- USP/NF 〈197〉 Spectroscopic Identification Tests
And that’s just the beginning
We offer much more – from standard pharmacopoeial methods to costumized analytical solutions. The overview above is just a first glimpse into what we can do.
Have a specific request?
Get in touch – we’ll find the right solution for you.
