Method directory
The list includes the standard procedures available at HHAC – in addition, we develop specific methods for release or stability testing on behalf of clients.
Climate-controlled storage and stability testing of active substances, excipients and finished products
| Test procedure | Test |
|---|---|
| ICH Q1A (R) EMA (CPMP/ICH/2736/99) (CPMP/QWP/122/02, rev 1) |
ICH-compliant stability testing |
| ICH Q1B EMA (CPMP/ICH/279/95) | ICH-compliant photostability testing |
| EMA (CPMP/QWP/2934/99) | In-use stability testing of finished medicinal products (in-use stability) |
Testing of photosensitive active substances and finished products while protected from light
| Test procedure | Test |
|---|---|
| HHAC AOG037 | Working protected from light |
High-performance liquid chromatography (HPLC) test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.29 | Identity testing of active substances and excipients using HPLC |
| Ph. Eur. 2.2.29 | Quantitative analysis of active substances and excipients using HPLC |
| Ph. Eur. 2.2.29 | Testing purity/related substances of active substances and excipients using HPLC |
Gas chromatography (GC) test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.28 | Identity testing of active substances and excipients using GC |
| Ph. Eur. 2.2.28 | Quantitative analysis of active substances and excipients using GC |
| Ph. Eur. 2.2.28 | Testing purity/related substances of active substances and excipients using GC |
| Ph. Eur. 2.4.24 | Identification and determination of residual solvents in active substances, excipients and medicinal products using head-space GC |
Thin-layer chromatography (TLC) test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.27 | Identity testing of active substances and excipients using TLC |
| Ph. Eur. 2.2.27 | Quantitative analysis of active substances and excipients using TLC |
| Ph. Eur. 2.2.27 | Testing purity/related substances of active substances and excipients using TLC |
Spectroscopy test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.24 | Identity testing of active substances and excipients using IR spectroscopy |
| Ph. Eur. 2.2.25 | Identity testing of active substances and excipients using UV-vis spectroscopy |
| Ph. Eur. 2.2.25 | Quantitative analysis of active substances and excipients using UV-vis spectroscopy |
Volumetric, gravimetric and wet-chemical test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.20 | Quantitative analysis of active substances and excipients using potentiometric titration |
| Ph. Eur. 2.5.1 | Determination of the acid number using acidimetric titration |
| Ph. Eur. 2.5.5 | Determination of the peroxide number using iodometric titration |
| Ph. Eur. 2.5.11 | Quantitative analysis of active substances using complexometric titration |
| Ph. Eur. 2.5.12 | Semi-micro-determination of water with the Karl Fischer method |
| Ph. Eur. 2.5.32 | Micro-determination of water – coulometric titration |
| Ph. Eur. 2.2.32 | Determination of the loss on drying |
| HHAC ANC034 | Determination of the loss on drying using infra-red dryers |
| Ph. Eur. 2.2.38 | Determination of the conductibility |
Dissolution test procedures
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.9.3 | Dissolution test for solid dosage forms |
Testing of physical state according to pharmacopoeia methods
| Test procedure | Test |
|---|---|
| Ph. Eur. 2.2.1 | Testing the clarity and degree of opalescence of liquids |
| Ph. Eur. 2.2.2 | Testing the degree of colouration of liquids |
| Ph. Eur. 2.2.3 | pH value – potentiometric method |
| Ph. Eur. 2.2.5 | Determination of the relative density |
| Ph. Eur. 2.2.6 | Determination of the refractive index |
| Ph. Eur. 2.2.35 | Determination of the osmolality |
| Ph. Eur. 2.9.1 | Determination of the disintegration time of tablets and capsules |
| Ph. Eur. Monograpie 0478 | Determination of the disintegration time of effervescent tablets |
| Ph. Eur. 2.9.7 | Determination of the friability of uncoated tablets |
| Ph. Eur. 2.9.8 | Determination of the 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 dosage units of single-dose forms |
References
| References |
|---|
| Ph. Eur.: European Pharmacopoeia |
| ICH: International Conference on Harmonisation |
| EMA: European Medicines Agency |
| CPMP: Committee for Proprietary Medicinal Products |