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

Spezifikation

Produktbezug:
Produktnummer 83885V02
Handelsname / Bezeichnung Vitamin B2 (Riboflavin), EP/BP/USP/E101i
CAS Nummer 83-88-5
Andere Bezeichnungen / Synonyme•Lactoflavin; •Lactoflavine; •Riboflavin; •Vitamin B2; •riboflavin;
EG Nummer201-507-1
Zolltarifnummer / CN-Code29362300
Molekulargewicht [g/mol]376,37
FormelC17H20N4O6


Parameter Test Method Specification Unit

Physikalische Parameter
Trocknungsverlust EP/BP ≤ 1,5 %
Trocknungsverlust USP ≤ 1,5 %

Identifikation
Gehalt E101(i) ≥ 98,0 %
Gehalt EP/BP 97,0  –  103,0 %
Gehalt USP 98,0  –  102,0 %

Verunreinigungen
Glührückstand EP/BP ≤ 0,1 %
Glührückstand USP ≤ 0,3 %
Schwermetalle (als Pb) (*) ≤ 10 ppm
Sulphatasche EP/BP ≤ 0,1 %
Sulphatasche USP ≤ 0,3 %
Verunreinigung USP Lumiflavin: A440 ≤ 0,025
Verunreinigung EP/BP Lumiflavin: Not more intense than the pricipal spot in the chromatogram obtained with ref. sol. (C) 0,025%

Restlösemittel
Restlösemittel Meet the USP requirements

Elementare Verunreinigungen
Arsen (As) (*) ≤ 1,0 ppm
Cadmium (Cd) (*) ≤ 1,0 ppm
Quecksilber (Hg) (*) ≤ 0,1 ppm
Blei (Pb) (*) ≤ 0,5 ppm

Mikrobiologische Daten
Bacillus cereus ≤ 10 cfu/g
Kolibakterien (*) ≤ 10
Escherichia Coli. (*) neg. in 1 g
Enterobacteriaceae (*) neg. in 1 g
Pseudomonas aeruginosa (*) neg. in 1 g
Salmonellen (*) neg. in 25 g
Staphylococcus Aureus (*) neg. in 1 g
Gesamtkeimzahl (*) ≤ 1000 CFU/g
Schimmel und Hefe (*) ≤ 100 CFU/g

Zusätzliche Angaben:

Entspricht der Monographie: EP 5 / BP 2008 / USP-NF / E 101(i)


Chemische Werke Hommel GmbH & Co.KG
Dieses Dokument wurde elektronisch erzeugt und ist ohne Unterschrift gültig.
Waltrop, 14. Jul. 2025
LF-Basis: AZ_Ch_H202403071FM (2024-03-29)
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.