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Metronidazole Hydroxy

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0% found this document useful (0 votes)
51 views2 pages

Metronidazole Hydroxy

Uploaded by

quality
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Certificate of Analysis Page 1/2

Version 1

676838 Lot: 821239


Metronidazole-hydroxy
1. General Information
Formula C6H9N3O4 Expiry Date 01 Dec 2028
Mol. Weight 187.15 g/mol Store at 4°C (in the dark)
CAS-No. 4812-40-2

2. Batch Analysis
Identity confirmed by LC-MS
Overall Purity 99.11 % (g/g) Expanded Uncertainty 0.62 % (g/g)
Assay Purity (HPLC) 99.11 % (g/g) Uncertainty 0.31 % (g/g)

Certified on 15 Nov 2023

by Corinna Gröst
RM Release

The overall purity is calculated by: Purity(%) = Assay purity*(100-water content-impurities)/100

The reported uncertainties are determined in accordance with ISO 17034 with a 95% confidence level (k=2). The Uncertainty is based on the combined
uncertainties, including uncertainties of characterization and stability testing. The expiry date is based on the current knowledge and holds only for proper
storage conditions in the originally closed flask. If the substance is proven to be unstable under the given storage conditions, you will be contacted
immediately.The warranty of this product is limited to the purchasing price of this product and to the first point of use.

Our standards are for laboratory use only and can be used as reference material for calibration of chromatographic systems or related analytical
techniques. For handling instructions see the MSDS. A minimum sample of 2 mg is recommended. Deploying less material will increase the uncertainty
by a factor 2 for half of sample and 4 for a quarter of sample. The material in the vial can be used multiple times, but it is strongly recommended that all
external negative influences to the material are considered and ruled out (e.g. high temperatures, UV-radiation, moisture, oxygen). It is strongly
recommended to open the vial at room temperature only and handle the material under inert gas if necessary. The integrity of the purity cannot be
guaranteed if the substance is handled under unfavorable conditions.

The balances used are calibrated with weights traceable to the national standards (DKD).

The HPC Standards GmbH produces reference materials according to ISO 17034. For further information, check:

HPC Standards GmbH | Am Wieseneck 7 | 04451 Cunnersdorf | Germany


Phone 0049 34291 3372-36 | Fax 0049 34291 3372-39 | [email protected]
Certificate of Analysis Page 2/2
Version 1

HPLC-Method
Article 676838
Lot-No. 821239
Column L=250mm, ID=4.6mm; Luna-Omega C18, 100A, 5µm
Eluent A Acetonitrile
Eluent B 0.1 % Phosphoric acid (Water)
Gradient time %A %B
0min 0 100
22.5min 90 10
25min 90 10
Flow 1.0 ml min-1
Detector UV-220nm
Injection-Volume 5 µl
Sample 0.3 mg ml-1 (Water)

Exemplary chromatogram of given method.


Version Article Lot Reason for Change Date
1 676838 821239 Initial Version 15 Nov 2023

HPC Standards GmbH | Am Wieseneck 7 | 04451 Cunnersdorf | Germany


Phone 0049 34291 3372-36 | Fax 0049 34291 3372-39 | [email protected]

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