Chemische Werke Hommel GmbH & Co. KG  

 Hommel-Logo

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 29883156CPEUB
Trade name / designation / denomination Amygdalin (Vitmin B17)
Bitter Apricot Extract
CAS number 29883-15-6
Other names / synonyms•2-phenyl-2-[[3,4,5-trihydroxy-6-[[3,4,5-trihydroxy-6-(hydroxymethyl)-2-oxanyl]oxymethyl]-2-oxanyl]oxy]acetonitrile; •amygdalin;
EC number249-925-3
Customs tariff number / CN code / TARIC29389090
Molecular weight [g / mol]457.42848
FormulaC20H27NO11


Parameter Test Method Specification Unit

Organoleptic test
Appearance organolepic fine Powder
Colour organolepic white
Flavor and taste characteristic
Odour organolepic characteristic

Physical parameter
Loss on drying Ph.Eur. 7.0 [2.8.17] ≤ 1,0 %
Bulk density Ph.Eur. 7.0 [2.9.34] 50  –  65 g/100 ml
Solubility in Water: insoluble

Identity
Assay HPLC ≥ 98,0 %
Identification HPTLC Identical to R. S. sample

Impurities
Residue on ignition Ph.Eur. 7.0 [2.4.16] ≤ 1,0 %
Heavy Metals (as Pb) ≤ 10 ppm
Pesticides USP36 [561] residues meet USP requirements

Residual Solvents
Residual solvents Ph.Eur. 7.0 [2.4.24] meet Pharm.Eur.

Elemental Impurities
Arsenic (As) Ph.Eur. 7.0 [2.2.58] / ICP-MS ≤ 1,0 ppm
Cadmium (Cd) Ph.Eur. 7.0 [2.2.58] / ICP-MS ≤ 1,0 ppm
Mercury (Hg) Ph.Eur. 7.0 [2.2.58] / ICP-MS ≤ 0,1 ppm
Lead (Pb) Ph.Eur. 7.0 [2.2.58] / ICP-MS ≤ 2,0 ppm

Microbiological data
Escherichia Coli. USP36 [62] Neg. CFU/g
Salmonella USP36 [62] Neg. CFU/g
Total Plate Count USP36 [61] ≤ 10,000 CFU/g
Yeast and Mould USP36 [61] ≤ 1,000 CFU/g

Particle size distribution
Particles USP36 [786] < 80 mesh: ≥ 100 %

Regulatory information:

BSE/TSE statement: Product does not contain ingredients or is produced by raw materials of animal origin.

GMO statement: Product does not contain ingredients or is produced by raw materials containing GMOs.

Irradiated Status: The product is not getting radiation, by Ultrahigh Temperatue Sterilization.

Nanoparticles: The product is not getting through nanoparticles processing


Supplemental information:

Shelf life: 36 month

Derivation: Extrahiert aus dem Samen von Prunus Armeniaca L. mit Wasser und Ethanol als Lösungsmittel.

Extrated from the seed of Prunus Armeniaca L. with water and ethanol as solvents.

Storage conditions: Store in a well-closed container away from moisture, light, heat, oxygen

Complies with monographie: EP7, USP36, GB

Packing: 25 kg paper-drums and two plastic-bags inside

Regional origin: CN

Usage: The product is suitable for a vegetarian nutrition.
The product is suitable for a vegan nutrition.
The product is suitable for lactose intolerance diet.
The product is suitable for people with coeliac disease and sprue.
The product is in compliance with Jewish dietary laws.
The product is in compliance with Islamic dietary laws.


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 06. Nov. 2019
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.


Layout-Version: V2018.11a