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Phenyramidol

The document is a certificate of analysis for a reference standard of Phenyramidol Hydrochloride. It provides details on the identity, purity, water content, residual solvents, and final assay results of the substance.

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srini_gc
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128 views7 pages

Phenyramidol

The document is a certificate of analysis for a reference standard of Phenyramidol Hydrochloride. It provides details on the identity, purity, water content, residual solvents, and final assay results of the substance.

Uploaded by

srini_gc
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
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Certificate of Analysis

Reference Standard

Phenyramidol Hydrochloride

Molecular Formula: C13H14N2O . HCl Catalogue Number: MM3188.00


Molecular Weight: 250.72 Lot Number: 64451
CAS Number: 326-43-2 Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point (DSC): 143 °C
Assay 'as is': 99.9 %

Date of shipment: 2015-July-05

This certificate is valid one year from the date of shipment provided the
substance is stored under the recommended conditions unopened in the
original container.

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

7 Pages
I. Identity
The identity of the reference substance was established by following analyses.

Ia. ¹H-NMR Spectrum

Conditions: 400 MHz, D₂O

The structure is confirmed by the signals of the spectrum and their interpretation.

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 2 of 7
Ib. Mass Spectrum
Method: HRMS; 3.5 kV ESI+; capillary temperature: 269 °C

Theoretical value: 215.11788

The signal of the MS spectrum is consistent with the theoretical value and its interpretation is consistent with the
structural formula.

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 3 of 7
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy

The signals of the IR spectrum and their interpretation are consistent with structural formula.

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 4 of 7
II. Purity

IIa. High Performance Liquid Chromatography (HPLC)


The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).

HPLC Conditions:
Column: Conditions: Detector: Injector:
Cortecs UPLC C18 + 0.50 ml/min, 40 °C DAD Auto
1.6 µm, 75 x 2.1 mm mob. Phase A: Water, 0.1 % HCOOH 230 nm 1 µl; 0.054 mg/ml in
mob. Phase B: Acetonitrile, 0.1 % HCOOH Acetonitrile/Water 50/50
(v/v)
0-1 min A/B 98/2
1-4 min A/B to 2/98
4-5 min A/B to 98/2
5-6 min A/B 98/2 (v/v)

Area Percent Report - Sorted by Signal

Pk# Retention Time Area Area %


1 2.268 11.3222 100.00

Totals 11.3222 100.00

For the calculation the system peaks were ignored. The content of the analyte was determined as the ratio of the
peak area of the analyte and the cumulative areas of the purities, added up to 100 %.

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 5 of 7
Results:
Average 100.00 %
Number of results n=3
Standard deviation < 0.01 %

IIb. Water Content


Method: Karl Fischer titration
Results:
Average 0.07 %
Number of results n=3
Standard deviation < 0.01 %

IIc. Residual Solvents


Method: ¹H-NMR
No significant amounts of residual solvents were detected (< 0.05 %).

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 6 of 7
III. Final Result
Chromatographic purity (HPLC) 100.00 %
Water content 0.07 %
Residual solvents No significant amounts of residual solvents were detected (< 0.05 %)
Assay (100 % method)¹ 99.93 %

The assay is assessed to be 99.9 % ‘as is’

The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.

Release Date: Signed:


Luckenwalde, 2015-February-03

Dr. Sabine Schröder


Product Release

¹ The calculation of the 100 % method follows the formula:


Purity (%)
Assay (%) = (100 % - volatile contents) *
100%
Volatile contents are considered as absolute contributions, purity is considered as relative contribution

MM3188.00 lot number 64451

LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, Germany

Page 7 of 7

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