Chemische Werke Hommel GmbH & Co. KG  

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Im Wirrigen 25
D-45731 Waltrop
Tel.: +49 2309 60699-0
Fax: +49 2309 60699-30
www.hommel-pharma.com
info@hommel-pharma.com

Specification

Concerning Product:
Article number 151619908CN4
Trade name / designation / denomination Herzkraut Extrakt
Motherwort herb dry extract
CAS number 151619-90-8
EC number


Parameter Test Method Specification Unit

Organoleptic test
Colour Brown Yellow
Flavor and taste characteristic
Odour characteristic

Physical parameter
Form fine powder
Loss on drying Eu. Pharm. v.v. (2.8.17) ≤ 5 %
Bulk density 0,30  –  0,70 g/ml

Identity
Assay TLC 4:1 TLC
Identification TLC complies

Impurities
Aflatoxins Eu. Phann. c.v. (2.8.18) B1 ＋ B2 ＋ G1 ＋ G2: ≤ 4 ppb
Aflatoxins Eu. Phann. c.v. (2.8.18) B1: ≤ 2 ppb
Residue on ignition Eu. Pharm. c.v. (2.4.16) ≤ 5 %
Pesticides According to Reg. (EC) 396/2005 and amendments ppm
Impurity According to Reg. (EC) 2023/915 and amendments %
Impurity TiO2: Absent According to Reg. (EC) 2022/63 %

Residual Solvents
Residual solvents According to Dir. (EC) 2009/32 and amendments

Microbiological data
Escherichia Coli. neg.
Salmonella neg.
Total Plate Count (TAMC): ≤ 10 000 CFU/g
Yeast and Mould (TYMC): ≤ 3 000 CFU/g

Particle size distribution
Particles < 80 mesh: ≤ 100 %

Regulatory information:

Allergens statement: Product is free of allergens according to Regulation (EU) No. 1169/2011 Annex II.

BSE/TSE statement: Risk of BSE/TSE contamination can be excluded.

Ethylene Oxide (EtO) Statement: ETO free

Food Grade Status: According to Reg. (EC) 178/2002

GMO statement: GMO Free According to Reg. (EC) 1829/2003 and 1830/2003 and amendments

Irradiated Status: No ionization or other radiation is permitted According to Reg. (EC) 1999/2 and 1999/3 and amendments

Nanoparticles: Absent According to Reg. (EC) 1169/2011

Vegan Status: Product is suitable for vegetarian, vegan or coeliac diets.


Supplemental information:

Shelf life: 3 years

Derivation: Extract from the leafs of Leonurus cardiaca L. with Ethanol

Storage conditions: Keep in tightly closed original sealed packing in a cool, clean and dry place, away from direct sunlight and heat.

Packing: According to Reg. (EC) 1935/2004 and Nr. 10/2011 and amendments

Regional origin: CN


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 06. Oct. 2023
We only confirm that we took over the data from our supplier accordingly. Despite careful working, errors in the takeover are not totally excluded. Some or all parts off the document may be translated due to our best knowledge from the original to give a better understanding. If you have any questions about specific details, please call us directly. Unless otherwise marked, these data do not originate from us and have not been tested by us on the correctness. The above information corresponds to the present state of our knowledge and is intended as a general description of our products and their possible applications. We make no warranties, expressed or implied, as to the information's accuracy, adequacy, sufficiency or freedom from defect and assumes no liability in connection with any use of this information. Any user of this product is responsible for determining the suitability of our products for its particular application. The foregoing information does not absolve the buyer of its own tests. Observing existing laws and regulations, is the responsibility of the buyer of our product. Nothing included in this information waives any of our General Terms and Conditions of Sale, which control unless it agrees other in writing. Any existing intellectual/industrial property rights must be observed. Due to possible changes in our products and applicable national and international regulations and laws, the status of our products could change. Material Safety Data Sheets providing safety precautions, that should be observed when handling or storing our products, are available upon request and are provided in compliance with applicable law. The user should obtain and review the applicable Material Safety Data Sheet information before handling any of these products. For additional information, please contact us.


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