Ph. Eur. Reference Standard - LEAFLET

Transcription

1 European Directorate for the Quality of Medicines & HealthCare European Pharmacopoeia (Ph. Eur.), Allée Kastner CS 00, F-0 Strasbourg (France) Tel. + (0) 0 Fax. + (0) For any questions: (HelpDesk) Ph. Eur. Reference Standard - LEAFLET ACTAEA RACEMOSA HRS batch Intended use This leaflet supplements the currently valid European Pharmacopoeia monograph(s) and/or general chapter(s) describing the suitable use of this Reference Standard. Further information about the Reference Standards is available in the on-line catalogue currently at (such as, batch validity statement and material safety data sheet). Instruction For use with the monograph Black cohosh (0) *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /

2 . Identification of Actaea racemosa. Monograph (Identification test C) Detection B: plate treatment as described in the monograph; daylight examination Requirement (Result B): see below the sequence of zones present in the chromatograms obtained with the reference solutions (a) and (b) and the test solution. Furthermore, other faint zones may be present in the chromatograms obtained with reference solution (a) and the test solution A brown zone (actein) A brown zone (-epi-deoxyactein) Actein: a brown zone A brown zone (actein) A brown zone (-epi--deoxyactein) - - A violet zone A violet zone A brown zone A violet zone A violet zone A brown zone Test solution. Example chromatograms Detection B: plate treatment as described in the monograph; daylight examination Track 0 Substance Isoferulic acid Norcimifugin Actein -epi- Deoxyactein Cimifugin Actaea racemosa HRS Actaea racemosa sample Cimicifuga foetida Cimicifuga heracleifolia Cimicifuga dahurica Cimicifuga americana 0 Corresponding reference solution *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /

3 Detection C: plate treatment as described in the monograph (test for Adulteration with Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. or C. heracleifolia Kom.), ultraviolet light at nm (for information only) 0 Note: This comparison of the different Cimicifuga species using detection C as described in the test on Adulteration with Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. or C. heracleifolia Kom. may provide useful additional information when substitution of Actaea racemosa with C. americana, C. foetida, C. heracleifolia or C. dahurica is suspected.. Substitution by Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. or C. heracleifolia Kom.. Monograph Detection A: ultraviolet light at nm Requirement (Results A): the chromatogram obtained with the test solution does not show any quenching zones more intense than those in the chromatogram obtained with reference solution (a) between RF value 0. and RF value 0... Example chromatograms 0 *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /

4 Track 0 Substance Isoferulic acid Norcimifugin Actein -epi- Deoxyactein Cimifugin Actaea racemosa HRS Actaea racemosa sample Cimicifuga foetida Cimicifuga heracleifolia Cimicifuga dahurica Cimicifuga americana Corresponding reference solution. Adulteration with Cimicifuga americana Michx., C. foetida L., C. dahurica (Turcz.) Maxim. or C. heracleifolia Kom.. Presence of C. americana at a level higher than 0 per cent.. Monograph Detection (A): ultraviolet light at nm Requirement (Results A): the chromatogram obtained with the test solution does not show any quenching zone at RF value A weak zone weak zones A weak zone A weak zone A weak zone C. americana (0 per cent).. Example chromatograms Track : the arrow points to the zone indicating the presence of C. americana at a level higher than 0 per cent *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /

5 Track Substance Corresponding reference solution actein Actaea racemosa HRS A. racemosa HRS containing % of C. heracleifolia A. racemosa HRS containing % of C. foetida A. racemosa HRS containing % of C. dahurica A. racemosa HRS containing 0% of C. americana A. racemosa HRS containing % of C. americana. Presence of C. foetida at a level higher than per cent.. Monograph Detection B: plate treatment as described in the monograph, ultraviolet light at nm Monograph requirement (Results B): the chromatogram obtained with the test solution does not show any intense fluorescent zone between R F value 0.0 and R F value 0.0 or at the same position as the intense fluorescent zone obtained with reference solution (c). Actein: a weak whitish zone Actein: a weak whitish zone Cimifugin: a bright fluorescent zone A weak whitish zone (actein) A bright fluorescent zone (cimifugin) A fluorescent zone Reference solution (c) C. foetida ( per cent).. Example chromatograms Track : the presence of one or both of the fluorescent zones marked by arrows indicates adulteration with C. Foetida at a level higher than per cent *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /

6 Track Substance Corresponding reference solution actein Actaea racemosa HRS A. racemosa HRS containing % of C. heracleifolia A. racemosa HRS containing % of C. foetida A. racemosa HRS containing % of C. dahurica A. racemosa HRS containing 0% of C. americana A. racemosa HRS containing % of C. americana. Presence of C. heracleifolia and/or C. dahurica at a level higher than per cent.. Monograph Detection (C): plate treatment as described in the monograph, ultraviolet light at nm Monograph requirement (Results B): the chromatogram obtained with the test solution does not show any bright fluorescent zone just above the zone due to actein. A weak brownish zone (actein) Actein: a weak brownish zone A bright fluorescent zone Actein: a weak brownish zone C. heracleifolia ( per cent) or C. dahurica ( per cent).. Example chromatograms Track : the arrows point to the zone indicating the presence of C. heracleifolia at a level higher than per cent Track : the arrows point to the zone indicating the presence of C. dahurica at a level higher than per cent Track Substance Corresponding reference solution actein Actaea racemosa HRS A. racemosa HRS containing % of C. heracleifolia A. racemosa HRS containing % of C. foetida A. racemosa HRS containing % of C. dahurica A. racemosa HRS containing 0% of C. americana A. racemosa HRS containing % of C. americana *00Y0000.0* Catalogue code: Y000 Revision 0 Date of issue: /0/0 /