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<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 Spetrometry
Ph. Eur. 2.2.58* Inductively Coupled Plasma-Mass Spetrometry
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. 2.9 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 performing the tests and establishment of certificates of analysis stays at TECHPharm GmbH.

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