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 9004346DPEU1
Trade name / designation / denomination mikrokristalline Cellulose, Typ 101
CAS number 9004-34-6
Other names / synonyms•Cellulose;
EC number232-674-9
232-674-9
Formula(C6H10O5)n


Parameter Test Method Specification Unit

Organoleptic test
Appearance white or almost white fine, crystalline or granular, slightly hygroscopic powder having fluidity, odorless

Physical parameter
Conductivity ≤ 75 μS/cm
Loss on drying 3,0  –  5,0 %
pH value 5,5  –  7,0
Bulk density 0,26  –  0,31 g/ml
Solubility in ammoniacal copper tetrammine pass
Solubility Practically insoluble in water, acetone, anhydrous ethanol, toluene, diethyl ether and dilute acids and swells in 50 g/l Sodium hydroxide solution.

Identity
Assay 97,0  –  102,0 %
Identification A, B, C passes test

Impurities
Residue on ignition ≤ 0,05 %
Heavy Metals (as Pb) ≤ 10 ppm
Soluble part Water ≤ 0,2 %
Soluble part Ether ≤ 0,05 %

Elemental Impurities
Arsenic (As) ≤ 2,0 ppm

Organic volatile impurities
Org. volat. Imp. Total complies

Microbiological data
Aerobic microorganisms ≤ 100 CFU/g
Escherichia Coli. neg. CFU/g
Pseudomonas aeruginosa neg.
Salmonella neg.
Staphylococcus Aureus neg.
Yeast and Mould ≤ 20 CFU/g

Particle size distribution
Particles D90 Malvern 90  –  156 ym
Particles D50 Malvern 40  –  75 µm
Particles D10 Malvern 14  –  30 µm
Particles Airjet < 250µm ≥ 99 %
Particles Airjet < 75µm 70,0  –  90,0 %

Supplemental information:

Shelf life: 4 years

Storage conditions: Keep in original, un-opened packing in ambient conditions protected form huminity and away from strongly odorous materials.

Complies with monographie: USP-NF, Ph.Eur., JP

Packing: 25 kg Carton


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 19. Oct. 2021
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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