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