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Specification

Concerning Product:
Article number 66905235CPUL
Trade name / designation / denomination Calciumgluconat Monohydrat, USP, FCC, E
CAS number 66905-23-5
Other names / synonyms•Calcium gluconate monohydrate; •Calcium gluconate monohydrate injectable;


Parameter Specification Unit

Organoleptic test
Appearance white, fine powder
Flavor and taste characteristic
Odour odoless

Physical parameter
Loss on drying ≤ 2,0 %
Molar mass ≤ 448,39 g/mol
pH value 5% solution 6,0  –  8,0 %
Reducing substances ≤ 1,0 %
Solubility in Water: soluble, in ethanol unsoluble

Identity
Assay ≥ 98,5 %
Identification A, B: complies

Impurities
Heavy Metals (as Pb) ≤ 20 ppm
Oxalate (as anhydros Oxalic Acid) ≤ 0,01 %
Phosphate (PO4) ≤ 0,01 %
Sulphates (SO4) ≤ 0,05 %

Elemental Impurities
Arsenic (As) ≤ 3 ppm
Chlorides (Cl) ≤ 0,07 %
Iron (Fe) ≤ 5 ppm
Lead (Pb) ≤ 2 ppm

Microbiological data
Escherichia Coli. negative
Salmonella negative
Staphylococcus Aureus negative
Total Plate Count ≤ 10000 KBE/g
Yeast and Mould ≤ 1000 KBE/g

Particle size distribution
Particles < 80 Mesh ≤ 100 %

Supplemental information:

Complies with monographie: USP, FCC, E 578


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 13. Mar. 2020
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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