Overview of analytical services offered by TECHPharm:
| Ph. Eur. 2.2 | Physical and physicochemical methods |
|---|---|
| Ph. Eur. 2.2.1 | Clarity and degree of opalescence of liquids |
| Ph. Eur. 2.2.2 | Degree of coloration of liquids |
| Ph. Eur. 2.2.3, USP<791> | Potentiometric determination of pH |
| Ph. Eur. 2.2.5, USP<841> | Relative density |
| Ph. Eur. 2.2.6, USP<831> | Refractive index |
| Ph. Eur. 2.2.7, USP<781> | Optical Rotation |
| Ph. Eur. 2.2.9, USP<911> | Capillary viscometer method |
| Ph. Eur. 2.2.10, USP<912> | Viscosity – rotating viscometer method |
| Ph. Eur. 2.2.11 | Destillation range |
| Ph. Eur. 2.2.12, USP<912> | Boiling point |
| Ph. Eur. 2.2.14, USP<741> | Melting point – capillary method |
| Ph. Eur. 2.2.15 | Melting point – open capillary method |
| Ph. Eur. 2.2.17 | Drop point |
| Ph. Eur. 2.2.18, USP<651> | Freezing point |
| Ph. Eur. 2.2.20, USP<541> | Potentiometric titration |
| Ph. Eur. 2.2.21, USP<851> | Fluorimetry |
| Ph. Eur. 2.2.22* | Atomic Emission Spectrometry |
| Ph. Eur. 2.2.23* | Atomic Absorption Spectrometry |
| Ph. Eur. 2.2.24, USP<197> | Absorption spectrophotometry, infrared |
| Ph. Eur. 2.2.25, USP<851> | Absorption spectrophotometry, ultraviolet and visible |
| Ph. Eur. 2.2.27, USP<621> | Thin-layer chromatography |
| Ph. Eur. 2.2.28, USP<621> | Gas chromatography |
| Ph. Eur. 2.2.29, USP<621> | Liquid chromatography |
| Ph. Eur. 2.2.30 | Size-exclusion chromatography |
| Ph. Eur. 2.2.32, USP<731> | Loss on drying |
| Ph. Eur. 2.2.35, USP<785> | Osmolality |
| Ph. Eur. 2.2.36 | Potentiometric determination of ionic concentration using ion-sensitive electrodes (e.g. F–, Pb2+, NO3–) |
| Ph. Eur. 2.2.38 | Conductivity |
| Ph. Eur. 2.2.44, USP<643> | Total Organic Carbon in water for pharmaceutical use; Total Nitrogen |
| Ph. Eur. 2.2.46, USP<621> | Chromatographic separation techniques |
| Ph. Eur. 2.2.49, USP<913> | Falling ball viscometer method |
| Ph. Eur. 2.2.57* | Inductively Coupled Plasma-Atomic Emission Spectrometry |
| Ph. Eur. 2.2.58* | Inductively Coupled Plasma-Mass Spectrometry |
| Ph. Eur. 2.3 | Identification |
| Ph. Eur. 2.3.1, USP<191> | Identification reactions of ions and functional groups |
| Ph. Eur. 2.3.2 | Identification of fatty oils by thin-layer chromatography |
| Ph. Eur. 2.3.4 | Odour |
| Ph. Eur. 2.4 | Limit tests |
| Ph. Eur. 2.4.1 | Ammonium |
| Ph. Eur. 2.4.2, USP<211>, JP 1.11 | Arsenic |
| Ph. Eur. 2.4.3 | Calcium |
| Ph. Eur. 2.4.4, USP<221> | Chlorides |
| Ph. Eur. 2.4.6 | Magnesium |
| Ph. Eur. 2.4.7 | Magnesium and alkaline-earth metals |
| Ph. Eur. 2.4.8, USP<231> | Heavy metals |
| Ph. Eur. 2.4.9, USP<241> | Iron |
| Ph. Eur. 2.4.10* | Lead in Sugars |
| Ph. Eur. 2.4.11 | Phosphates |
| Ph. Eur. 2.4.12 | Potassium |
| Ph. Eur. 2.4.13,USP<221> | Sulfates |
| Ph. Eur. 2.4.14, USP<281> | Sufated ash / Residue on Ignition |
| Ph. Eur. 2.4.15* | Nickel in Polyols |
| Ph. Eur. 2.4.16 | Total ash |
| Ph. Eur. 2.4.17, USP<206> | Aluminium |
| Ph. Eur. 2.4.19 | Alkaline impurities in fatty oil |
| Ph. Eur. 2.4.22, USP<401> | Composition of fatty acids by gas chromatography |
| Ph. Eur. 2.4.24, USP<467> | Identification and control of residual solvents |
| Ph. Eur. 2.4.25, USP<228> | Ethylene oxide and dioxane |
| Ph. Eur. 2.4.27* | Heavy metals in herbal drugs and fatty oils |
| Ph. Eur. 2.4.31* | Nickel in hydrogenated vegetable oils |
| Ph. Eur. 2.5 | Assays |
| Ph. Eur. 2.5.1, USP<401> | Acid value |
| Ph. Eur. 2.5.2, USP<401> | Ester value |
| Ph. Eur. 2.5.3, USP<401> | Hydroxyl value |
| Ph. Eur. 2.5.4, USP<401> | Iodine value |
| Ph. Eur. 2.5.5, USP<401> | Peroxide value |
| Ph. Eur. 2.5.6, USP<401> | Saponification value |
| Ph. Eur. 2.5.7, USP<401> | Unsaponificable matter |
| Ph. Eur. 2.5.9, USP<461> | Determination of nitrogen by sulfuric acid digestion |
| Ph. Eur. 2.5.10, USP<471> | Oxygen Flask Method |
| Ph. Eur. 2.5.11 | Complexometric titrations |
| Ph. Eur. 2.5.12, USP<921> | Water: semi-micro determination |
| Ph. Eur. 2.5.29, USP<525> | Sulfur dioxide |
| Ph. Eur. 2.5.30 | Oxidising substances |
| Ph. Eur. 2.5.32, USP<921> | Water: micro determination |
| Ph. Eur. 2.5.36 | Anisidine value |
| Ph. Eur. 2.6 | Biological tests |
| Ph. Eur. 2.6.12, USP<61> | Microbiological examination of non-sterile products: microbial enumeration tests |
| Ph. Eur. 2.6.13, USP<62> | Microbiological examination of non-sterile products: test for specified micro-organisms |
| Ph. Eur. 2.6.14, USP<85> | Bacterial endotoxins |
| Ph. Eur. 2.6.31 | Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation |
| Ph. Eur. 2.6.32 | Test for bacterial endotoxins using recombinant factor C |
| Ph. Eur. 2.9 | Pharmaceutical technical procedures |
| Ph. Eur. 2.9.1, USP<701> | Disintegration of tablets and capsules |
| Ph. Eur. 2.9.2 | Disintegration of suppositories and pessaries |
| Ph. Eur. 2.9.3, USP<711> | Dissolution test for solid dosage forms |
| Ph. Eur. 2.9.4 | Dissolution test for transdermal patches |
| 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. 2.9.7, USP<1216> | Friability of uncoated tablets |
| Ph. Eur. 2.9.8, USP<1217> | Resistance to crushing of tablets |
| Ph. Eur. 2.9.9 | Measurement of consistency by penetrometry |
| Ph. Eur. 2.9.10 method B | Ethanol content and alcoholimetric tables |
| Ph. Eur. 2.9.11 | Test for methanol and 2-propanol |
| Ph. Eur. 2.9.12 | Sieve test |
| Ph. Eur. 2.9.16 | Flowability |
| Ph. Eur. 2.9.19, USP<788> | Particulate contamination: sub-visible particles |
| Ph. Eur. 2.9.20 | Particulate contamination: visible particles |
| Ph. Eur. 2.9.31; USP<429> | Particle size analysis by laser light diffraction |
| Ph. Eur. 2.9.34; USP<616> | Bulk density and tapped density of powders |
| Ph. Eur. 2.9.35; USP<811> | Powder Fineness |
| Ph. Eur. 2.9.37; USP<776> | Optical microscopy |
| Ph. Eur. 2.9.38, USP<786> | Particle-size distribution estimation by analytical sieving |
| Ph. Eur. 2.9.40, USP<905> | Uniformity of dosage units |
| USP<251> | Lead |
| USP<291> | Selenium |
| USP<645> | Water Conductivity |
| USP<733> | Loss on Ignition |
| USP<1065> | Ion Chromatography |
| ICH Q1B | Light Stability |
| ICH Q1A (R2) | Stability Storage Standard conditions 25 °C ± 2 °C, 60 % RH ± 5 % RH 30 °C ± 2 °C, 65 % RH ± 5 % RH 30 °C ± 2 °C, 75 % RH ± 5 % RH 40 °C ± 2 °C, 75 % RH ± 5 % RH Further climates on request |
* in cooperation with a partner laboratory. Responsibility for reported results remains with TECHPharm GmbH.
