Special focus points and experiences have been summarised in the TECHPharm-competence centers.

In the following we like to present our general services and our technical possibilities in detail:

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 Potentiometric determination of pH
Ph. Eur. 2.2.5, USP Relative density
Ph. Eur. 2.2.6, UPS Refractive index
Ph. Eur. 2.2.7, USP Optical Rotation
Ph. Eur. 2.2.9, USP Capillary viscometer method
Ph. Eur. 2.2.10, USP Viscosity – rotating viscometer method
Ph. Eur. 2.2.11 Destillation range
Ph. Eur. 2.2.12, USP Boiling point
Ph. Eur. 2.2.14 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 Freezing point
Ph. Eur. 2.2.19 Amperometric titration
Ph. Eur. 2.2.20, USP Potentiometric titration
Ph. Eur. 2.2.21, USP Fluorimetry
Ph. Eur. 2.2.22* Atomic Emission Spectrometry
Ph. Eur. 2.2.23* Atomic Absorption Spectrometry
Ph. Eur. 2.2.24, USP Absorption spectrophotometry, infrared
Ph. Eur. 2.2.25, USP Absorption spectrophotometry, ultraviolet and visible
Ph. Eur. 2.2.27, USP Thin-layer chromatography
Ph. Eur. 2.2.28, USP Gas chromatography
Ph. Eur. 2.2.29, USP Liquid chromatography
Ph. Eur. 2.2.30 Size-exclusion chromatography
Ph. Eur. 2.2.32, USP Loss on drying
Ph. Eur. 2.2.35, USP 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 Total Organic Carbon in water for pharmaceutical use; Total Nitrogen
Ph. Eur. 2.2.46, USP Chromatographic separation techniques
Ph. Eur. 2.2.49, USP Falling ball viscometer method
Ph. Eur. 2.2.57 Inductively Coupled Plasma-Atomic Emission Spetrometry
Ph. Eur. 2.2.60, USP Melting point – instrumental method
Ph. Eur. 2.3 Identification
Ph. Eur. 2.3.1, USP 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, JP 1.11 Arsenic
Ph. Eur. 2.4.3, USP Calcium
Ph. Eur. 2.4.4, USP Chlorides
Ph. Eur. 2.4.6 Magnesium
Ph. Eur. 2.4.7 Magnesium and alkaline-earth metals
Ph. Eur. 2.4.8, USP Heavy metals
Ph. Eur. 2.4.9, USP 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 Sulfates
Ph. Eur. 2.4.14, USP 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 Aluminium
Ph. Eur. 2.4.19 Alkaline impurities in fatty oil
Ph. Eur. 2.4.21 Foreign oils in fatty oil by thin-layer chromatography
Ph. Eur. 2.4.22, USP Composition of fatty acids by gas chromatography
Ph. Eur. 2.4.24, USP Identification and control of residual solvents
Ph. Eur. 2.4.25, USP Ethylene oxide and dioxane
Ph. Eur. 2.4.27*  Heavy metals in herbal drugs and fatty oils
Ph.Eur. 2.4.29 Composition of fatty acids in oils rich in omega-3 acids
Ph. Eur. 2.4.30 Ethylene glycol and diethylene glycol in ethoxylated substances
Ph. Eur. 2.4.31* Nickel in hydrogenated vegetable oils
Ph. Eur. 2.5 Assays
Ph. Eur. 2.5.1, USP Acid value
Ph. Eur. 2.5.2, USP Ester value
Ph. Eur. 2.5.3, USP Hydroxyl value
Ph. Eur. 2.5.4, USP Iodine value
Ph. Eur. 2.5.5, USP Peroxide value
Ph. Eur. 2.5.6, USP Saponification value
Ph. Eur. 2.5.7, USP Unsaponificable matter
Ph. Eur. 2.5.8 Determination of primary aromatic amino-nitrogen
Ph. Eur. 2.5.9, USP Determination of nitrogen by sulfuric acid digestion
Ph. Eur. 2.5.10, USP Oxygen Flask Method
Ph. Eur. 2.5.11 Complexometric titrations
Ph. Eur. 2.5.12, USP Water: semi-micro determination
Ph. Eur. 2.5.29, USP Sulfur dioxide
Ph. Eur. 2.5.30 Oxidising substances
Ph. Eur. 2.5.32, USP Water: micro determination
Ph.Eur. 2.5.36 Anisidine value
Ph. Eur. 2.6 Biological tests
Ph. Eur. 2.6.12, USP Microbiological examination of non-sterile products: microbial enumeration tests
Ph. Eur. 2.6.13, USP Microbiological examination of non-sterile products: test for specified micro-organisms
Ph. Eur. 2.6.14, USP Bacterial endotoxins
Ph. Eur. 2.6.31 Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation
Ph. Eur. 2.9 Pharmaceutical technical procedures
Ph. Eur. 2.9.1, USP Disintegration of tablets and capsules
Ph. Eur. 2.9.2 Disintegration of suppositories and pessaries
Ph. Eur. 2.9.3, USP 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 Friability of uncoated tablets
Ph. Eur. 2.9.8, USP Resistance to crushing of tablets
Ph. Eur. 2.9.9 Measurement of consistency by penetrometry
Ph. Eur. 2.9.10 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 Particulate contamination: sub-visible particles
Ph. Eur. 2.9.20 Particulate contamination: visible particles
Ph. Eur. 2.9.31; USP Particle size analysis by laser light diffraction
Ph. Eur. 2.9.34; USP Bulk density and tapped density of powders
Ph. Eur. 2.9.35; USP Powder Fineness
Ph. Eur. 2.9.37; USP Optical microscopy
Ph. Eur. 2.9.38, USP Particle-size distribution estimation by analytical sieving
Ph. Eur. 2.9.40, USP Uniformity of dosage units
Ph. Eur. 3.1 Materials used for the manufacture of containers
Ph. Eur. 3.1.5 Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations
USP Lead
USP Selenium
USP Water Conductivity
USP Loss on Ignition
USP 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 performing the tests and establishment of certificates of analysis stays at TECHPharm GmbH.

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