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
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.
