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 59303V02
Trade name / designation / denomination Vitamin B9 (Folsäure), USP
CAS number 59-30-3
Other names / synonyms•(2S)-2-[[[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]phenyl]-oxomethyl]amino]pentanedioic acid; •folic acid;
EC number200-419-0
Customs tariff number / CN code / TARIC29362900
Molecular weight [g / mol]441,4
FormulaC19H19N7O6


Parameter Test Method Specification Unit

Organoleptic test
Appearance USP2024 Yellow, yellow-brownish, or yellowish-orange, crystalline powder

Physical parameter
Water content USP2024 ≤ 8,5 %

Identity
Assay USP2024 on dry basis 97,0  –  102,0 %
Identification USP2024 Ratio: A256/A365: 2,80  –  3,00

Impurities
Residue on ignition USP2024 ≤ 0,3 %
Related substances USP2024 ≤ 2,0 % [w/w]

Residual Solvents
Residual solvents No solvent is used or produced in the manufacture of the product.

Elemental Impurities
Arsenic (As) AAS, in-house ≤ 0,5 mg/kg
Cadmium (Cd) AAS, in-house ≤ 0,5 mg/kg
Mercury (Hg) AAS, in-house ≤ 0,1 mg/kg
Lead (Pb) AAS, in-house ≤ 0,5 mg/kg

Microbiological data
Aerobic microorganisms ChP TAMC ≤ 100 CFU/g
Escherichia Coli. ChP neg.
Salmonella ChP neg.
Staphylococcus Aureus ChP neg.
Yeast and Mould ChP (TYMC): ≤ 10 CFU/g

Supplemental information:

Shelf life: 3 years

Storage conditions: Preserve in well-closed, light-resistant containers

Complies with monographie: USP2024

Regional origin: CN


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 11. Jul. 2025
LF-Basis: (2024-12-12)
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.