Bei der folgenden Liste handelt es sich um einen Auszug unserer Leistungen ohne Anspruch auf Vollständigkeit. Sollte die von Ihnen gewünschte Analyse nicht aufgeführt sein, bitten wir Sie, uns einfach darauf anzusprechen (info(Replace this parenthesis with the @ sign)techpharm.de). Gerne prüfen wir für Sie die Umsetzbarkeit der Ph. Eur., USP, JP, BP, DAB, DAC oder FCC Monographie sowie Ihrer kundeneigenen Prüfmethode bei TECHPharm und erstellen Ihnen ein entsprechendes Angebot. Bisher nicht bei TECHPharm durchgeführte Analysen werden gemäß Ph. Eur. Vorgaben oder USP <1226> in unserem Hause etabliert.

Ph. Eur. 2.6.32Test for bacterial endotoxins using recombinant factor C

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. 2.2.38 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 Kooperation mit einem Partnerlaboratorium, wobei die Verantwortung für die Durchführung und Berichtlegung bei TECHPharm verbleibt.

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