REFERENCE MATERIAL CERTIFICATE
Reference Material
This certificate is designed in accordance with ISO Guide 31. This reference material (RM) was designed, produced and
verified in accordance with a registered quality management system ISO 9001. All measurements were performed
according to ISO/IEC 17025 by a DAkkS accredited laboratory (D-PL-19883-01-00).
Product Name
Doxycycline hyclate
Product Code Lot Number
DRE-C13084280 1402730
CAS No. Format
24390-14-5 Neat
Mol. Weight Expiry Date
1025.87 19 Dec 2027
Mol. Formula Storage Temp
2C22H24N2O8 · C2H6O · 2ClH · H2O 20°C ± 4°C
CERTIFIED CERTIFIED
Purity Expanded Uncertainty (U)
99.5% (g/g) 3.0% (g/g)
Uncertainty
The certified value(s) and uncertainty(ies) are determined in accordance with EURACHEM/CITAC Guide for
“Quantifying Uncertainty in Analytical Measurement, 3rd edition”, with an 95% confidence level (k=2). Uncertainty is
based on the Total Combined Uncertainty, including uncertainties of characterisation and stability testing. Stability
values are based on real evidence opposed to simulation.
The producer certifies that this reference material meets the specification stated in this certificate until the expiry date,
provided it is stored unopened at the recommended temperature herein. Product warranties for this reference material are
set out in the terms and conditions of purchase.
CERTIFIED BY CERTIFIED ON
RM Release
N. Müller 19 Dec 2023
Version 1 DRE-C13084280 1402730 Page 1 of 2
REFERENCE MATERIAL CERTIFICATE
Instrument
HPLC/DAD+MS
CHROMATOGRAM
Column
YMC-Pack ODS-AQ, 3 μm, 150 x 3
mm
No chromatogram available. Method Details
Eluent A: 100% Acetonitrile
Eluent B: Water + Formic Acid
Time [min] Eluent A [%] Eluent B [%]
0 15 85
3 15 85
9 35 65
10 98 2
14 98 2
Flow
0.5 mL/min
Method of Characterisation
Purity = 100% - Assay impurities – Water excess (KF)
Method of Identification
EA, NMR, RT, IR, MS
Batch Information
Water Content: 2.2% (g/g) by Karl-Fischer-Titration (U(exp) = 0.1% (g/g)).
Intended Use standards (DKD). The calibration of Instructions for use
This RM is intended for use in a the balances is verified daily internally It is recommended to use 1 mg as the
laboratory as a calibration and quality and annually by an external accredited minimum sample size and if less
control standard or in method calibration service. Chromatographic material is used, to increase the
development for analytical methods are traceable to the certified uncertainty by a factor of two
techniques. International System of Units (SI). for half sample and four for a quarter
of sample. If storage after opening is
Safety Storage necessary, the RM should be tightly
Proper precautions should be The RM should be stored in the closed and kept from light and
observed while handling. See Safety original sealed container at the moisture. If the RM was in a sealed
Data Sheet. indicated temperature. ampoule, it should be transferred to a
vial with minimum head space. Visit
Traceability the support section of our website
The balances used for gravimetric lgcstandards.com for a series of
measurements are calibrated with Dr. Ehrenstorfer Tech Tip videos and
weights traceable to the national frequently asked questions.
LGC Labor GmbH
Bgm.-Schlosser-Straße 6A
86199 Augsburg, Germany
T | +49 821 906080
F | +49 821 9060888
E | dr.ehrenstorfer@lgcgroup.com
Version 1 DRE-C13084280 1402730 Page 2 of 2
