List of methods
The listing includes the standard methods available at HHAC – in addition, we develop specific methods for release or stability testing on customer order.
Performance of climatic storage and stability tests of active pharmaceutical ingredients, excipients and finished products
| Test methods | Testing |
|---|---|
| ICH Q1A (R) EMA (CPMP/ICH/2736/99) (CPMP/QWP/122/02, rev 1) |
Stability testing according to ICH |
| ICH Q1B EMA (CPMP/ICH/279/95) | Photostability tests according to ICH |
| EMA (CPMP/QWP/2934/99) | Testing of the in-use stability of finished medicinal products (in-use stability) |
Testing of light-sensitive active pharmaceutical ingredients and finished drug products under light protection
| Test methods | Testing |
|---|---|
| HHAC AOG037 | Working under light protection |
High performance liquid chromatography (HPLC) test method
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.29 | Testing the identity of active pharmaceutical ingredients and excipients by HPLC |
| Ph. Eur. 2.2.29 | Determination of the content of active pharmaceutical ingredients and excipients by HPLC |
| Ph. Eur. 2.2.29 | Testing for purity/related substances of active pharmaceutical ingredients and excipients by HPLC |
Test method Gas chromatography (GC)
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.28 | Testing for identity of active pharmaceutical ingredients and excipients by GC |
| Ph. Eur. 2.2.28 | Determination of content of active pharmaceutical ingredients and excipients by GC |
| Ph. Eur. 2.2.28 | Testing for purity/related substances of active pharmaceutical ingredients and excipients by GC |
| Ph. Eur. 2.4.24 | Identification and control of residual solvents in active pharmaceutical ingredients, excipients and drugs by headspace GC |
Test method Thin layer chromatography (TLC)
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.27 | Testing the identity of active pharmaceutical ingredients and excipients by TLC |
| Ph. Eur. 2.2.27 | Determination of content of active pharmaceutical ingredients and excipients by TLC |
| Ph. Eur. 2.2.27 | Testing for purity/related substances of active pharmaceutical ingredients and excipients by means of TLC |
Test method Spectroscopy
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.24 | Absorption spectrophotometry, infrared |
| Ph. Eur. 2.2.25 | Absorption spectrophotometry, ultraviolet and visible |
| Ph. Eur. 2.2.25 | Determination of the content of active pharmaceutical ingredients and excipients by UV-Vis spectroscopy |
Titrimetric, gravimetric and wet chemical test methods
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.20 | Content determination of active pharmaceutical ingredients and excipients by potentiometric titration |
| Ph. Eur. 2.5.1 | Determination of acid value by acidimetric titration |
| Ph. Eur. 2.5.5 | Determination of the peroxide value by iodometric titration |
| Ph. Eur. 2.5.11 | Determination of the content of active pharmaceutical ingredients by complexometric titration |
| Ph. Eur. 2.5.12 | Semi-micro determination of water by the Karl Fischer method |
| Ph. Eur. 2.5.32 | Micro determination of water – Coulometric titration |
| Ph. Eur. 2.2.32 | Determination of loss on drying |
| HHAC ANC034 | Determination of loss on drying by infrared dryer |
| Ph. Eur. 2.2.38 | Determination of conductivity |
Testing of the release of the active ingredient
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.9.3 | Dissolution test for solid dosage forms |
Testing of composition according to pharmacopoeial methods
| Test methods | Testing |
|---|---|
| Ph. Eur. 2.2.1 | Testing of clarity and degree of opalescence of liquids |
| Ph. Eur. 2.2.2 | Determination of degree of coloration of liquids |
| Ph. Eur. 2.2.3 | pH value – potentiometric determination |
| Ph. Eur. 2.2.5 | Determination of relative density |
| Ph. Eur. 2.2.6 | Determination of refractive index |
| Ph. Eur. 2.2.10 | Viscosity – Rotating viscometer method |
| Ph. Eur. 2.2.35 | Determination of osmolality |
| Ph. Eur. 2.9.1 | Determination of disintegration of tablets and capsules |
| Ph. Eur. Monograph 0478 | Determination of disintegration of effervescent tablets |
| Ph. Eur. 2.9.7 | Determination of the friability of uncoated tablets |
| Ph. Eur. 2.9.8 | Determination of resistance to crushing of tablets |
| Ph. Eur. 2.9.20 | Determination of particulate contamination (visible particles) |
| Ph. Eur. 2.9.40 | Determination of uniformity of single-dose dosage forms |
| DAB V.6.9.N1 | Boiling temperature |
Sources
Sources
Ph. Eur: European Pharmacopoeia
ICH: International Conference on Harmonisation
EMA: European Medicines Agency
CPMP: Committee for Proprietary Medicinal Products
DAB: German Pharmacopoeia
DAkkS Background List
Here you can download the DAkkS background list:
LIST OF
Methods
The above listing of our methods summarizes the standard methods available at HHAC. In addition, we develop specific methods for release or stability testing for our customers.
