Specification
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Concerning Product: |
| Article number | 1115704PPEBU |
| Trade name / designation / denomination | Metformin HCl EP/BP/USP |
| CAS number | 1115-70-4 |
| Other names / synonyms | •1,1-DIMETHYLBIGUANIDE;
•1,1-DIMETHYLBIGUANIDE HYDROCHLORIDE;
•1,1-Dimethylbiguanide Hydrochloride;
•1,1-Dimethylbiguanide hydrochloride;
•1,1-Dimethylbiguanide, Hydrochloride;
•1-carbamimidamido-N,N-dimethylmethanimidamide hydrochloride;
•3-(diaminomethylidene)-1,1-dimethylguanidine hydrochloride;
•METFORMIN;
•METFORMIN HCL;
•Metformin HCl; |
| EC number | 214-230-6 |
| Customs tariff number / CN code / TARIC | 29252900 |
| Molecular weight [g / mol] | 165.62458 |
| Formula | C4H12ClN5 |
| Parameter |
Specification |
Unit |
Organoleptic test |
| Appearance of solution |
clear and colourless |
| Appearance |
white crystalline powder |
Physical parameter |
| Loss on drying |
(105° C/5h): ≤ 0,5 |
% [w/w] |
| Solubility |
in Water: freely soluble
in Alcohol: slightly soluble
in Acetone and Methylene Chloride: insoluble |
Identity |
| Assay |
98,5 – 101,0 |
% [w/w] |
| Identification |
B. (IR): IR Spectrum complies |
| Identification |
E. Chloride: complies |
Impurities |
| Heavy Metals (as Pb) |
≤ 10 |
ppm |
| Sulphated ash |
≤ 0,1 |
% [w/w] |
| Impurity |
F.: ≤ 0,05 |
% [w/w] |
| Related substances |
Impurity A: ≤ 0,02 |
% [w/w] |
| Related substances |
Impurity B: ≤ 0,05 |
% [w/w] |
| Related substances |
total impurities: ≤ 0,2 |
% [w/w] |
| Related substances |
unspecified impurity: ≤ 0,05 |
% [w/w] |
Particle size distribution |
| Particles |
< 100 µm ≥ 90 |
% |
| Particles |
< 180 µm ≤ 100 |
% |
Regulatory information:
BSE/TSE statement:
Product does not contain ingredients or is produced by raw materials of animal origin.
Registration status:
CEP
Residual solvents:
Methanol: ≤ 1000 ppm
Xylene: ≤ 500 ppm
Supplemental information:
Shelf life:
5 years
Derivation:
synthetic
Complies with monographie:
PhEur-9.0, BP-2018, USP-40
Regional origin:
IND
Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
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Waltrop, 24. Jul. 2019
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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
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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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