Pharmacopoeial Testing

Experience

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

Bioanalytical Services and 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

Freisetzung und Gleichförmigkeit

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

Your individual offer

And that’s just the beginning

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