EDQM FAQs
ELABORATION AND REVISION
- How are monographs selected for inclusion in the European Pharmacopoeia?
- How can I submit a draft monograph for inclusion in the European Pharmacopoeia?
- How can I propose a revision of a monograph?
- How long does the revision of a monograph take?
- How can I find out why revisions were made to the European Pharmacopoeia?
- How can I comment on a text published in Pharmeuropa?
- How can I order a qualified sample that is proposed in a Pharmeuropa draft text?
COMPLIANCE WITH A MONOGRAPH
- When is an article considered to be of Ph. Eur. quality?
- How can I find the reference number, exact name or status of a European Pharmacopoeia monograph for a particular substance?
- How can I find out if a monograph/a general chapter is included in the Ph. Eur.?
- How can I obtain the official analytical procedures of the European Pharmacopoeia? Could you send me a PDF file, for example?
- What measures do I need to take before using an analytical procedure that is given in Ph. Eur. monographs?
- Can I use a reagent or analytical procedure other than the one published in the Ph. Eur.?
- When can I apply the specification of a new or revised monograph?
- What is a ‘nominal value’ in Ph. Eur. texts?
- What is ‘stated potency’?
MEASURING QUANTITIES
- What accuracy is required for measuring quantities stated in Ph. Eur. texts?
- Am I allowed to round off measurements?
REAGENTS AND SUPPLIERS
- Can you provide details of suppliers of monograph substances?
- How can I find out which chromatography column or other equipment or reagent was used during the elaboration of a monograph?
- Do you recommend using any particular reagent for a monograph/general chapter?
- How long can I store a reagent or a solution before using it?
- Volumetric solutions (4.2.2): I have trouble achieving the repeatability criterion of 0.2% relative standard deviation (RSD).
- How can I standardise a volumetric solution?
- How should I prepare a more dilute volumetric solution than the one described?
CHARACTERS AND IDENTIFICATION
- I have trouble meeting the criteria under ’Characters’.
- Do I have to perform all the tests described in the ‘Identification’ section of a monograph?
- Is it possible to perform a type of measurement (such as ATR) different from that described in the monograph?
IMPURITIES AND CHROMATOGRAPHY
- Can you provide relative retentions for ‘Other detectable impurities’ cited in the ‘Impurities’ section of a monograph?
- Can the EDQM provide typical chromatograms for tests described in the monographs?
- I have observed a slight difference in retention times/retardation factors compared with the monograph. What deviation is considered acceptable?
- What is the limit for specified/unspecified/unknown impurities?
- How can I determine the total impurities? Which peaks can be disregarded?
- The limit for unspecified impurities in the monograph is higher than the values defined in general monograph Substances for pharmaceutical use (2034) (Table 2034.-1) and general chapter 5.10. Control of impurities in substances for pharmaceutical use.
- How are limits for impurities defined in monographs?
- I observe baseline separation when the monograph describes a peak-to-valley ratio.
- I cannot achieve the system suitability or signal-to-noise criteria with the described chromatographic method. Can I make any adjustments?
- The monograph does not specify a correction factor for a specified impurity.
- The monograph does not include chemical reference substances or relative retentions for specified impurities.
- What is the difference between a peak area comparison and a quantitative limit for related substances?
- How should the test requirements be applied in related substances tests?
GENERAL CHAPTER 2.2.46 (11.0)
- SYSTEM SENSITIVITY
- PEAK SYMMETRY
- IMPLEMENTATION OF GENERAL CHAPTER 2.2.46 FOR EXISTING MONOGRAPHS
- IMPLEMENTATION OF GENERAL CHAPTER 2.2.46 FOR IN-HOUSE PROCEDURES
WATER - LOSS ON DRYING - SOLVENTS
- What is the difference between ‘dried’ and ‘anhydrous’ substances?
- The definition of substance X gives the content as dried or anhydrous. Do the solvents need to be taken into account when determining the assay?
- How do I apply general chapter 2.5.12 if the water content of my sample is below 2.5 mg?
- In general chapter 2.5.12, what solvent should I use for water determination?
- How can I perform the suitability test described in general chapter 2.5.12?
- Does the suitability requirement described in general chapter 2.5.12 apply to both method A and B?
- Does the suitability test described in general chapter 2.5.12 have to be run every time?
- Are procedures 2.5.12 and 2.5.32 interchangeable?
PHARMACEUTICAL TECHNICAL PROCEDURES
- When should I apply general chapter 2.9.40. Uniformity of dosage units?
- Dissolution test for solid dosage forms: what is the quantity Q?
- Dissolution test for solid dosage forms: I do not understand how to interpret the acceptance criteria. Could you provide an example?
MICROBIOLOGY
- Microbiology texts (e.g. chapters 2.6.1, 2.6.12, 2.6.13, 2.7.2, monograph 0008): can microbial strains other than those that are cited in the Ph. Eur. be used?
- Other questions on general chapters 2.6.12, 2.6.13, 5.1.1, 5.1.2, 5.1.3 and 5.1.4
ELEMENTAL IMPURITIES
MEDICINAL PRODUCT MONOGRAPHS
- Does a monograph on a medicinal product containing a chemically defined active substance apply to all strengths and formulations?
- What principles apply to disintegration tests described in medicinal product monographs?
- Why can the limit for total impurities in a monograph on medicinal product containing a chemically defined active substance be lower than the limit for total impurities in the corresponding active substance monograph?
MISCELLANEOUS
- Should we use “sulf...” or “sulph...” for the English name of our substance?
- What is the status of the monograph on Gonadotrophin, equine serum, for veterinary use (0719)?
- My question about the content of the European Pharmacopoeia monographs and general chapters is not in the FAQs – how can I contact the EDQM?