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This document provides information about an Adapalene Impurity Standard reference substance from the British Pharmacopoeia. It includes the declared content, intended use, reference chromatograms, and column and method details for analyzing the substance. The chromatograms show two identifiable impurities, A and D. Additional information notes a correction to the monograph regarding the actual content of Impurity D in this reference standard batch.

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11 views

Preview

This document provides information about an Adapalene Impurity Standard reference substance from the British Pharmacopoeia. It includes the declared content, intended use, reference chromatograms, and column and method details for analyzing the substance. The chromatograms show two identifiable impurities, A and D. Additional information notes a correction to the monograph regarding the actual content of Impurity D in this reference standard batch.

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Con Bò Sữa Thất Tình
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© © All Rights Reserved
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British Pharmacopoeia Commission Secretariat

MHRA, 10 South Colonnade, Canary Wharf


London E14 4PU
United Kingdom

British Pharmacopoeia Commission Laboratory


Queen’s Road
Teddington, TW11 0LY
United Kingdom

www.pharmacopoeia.com
www.pharmacopoeia.com

BRITISH PHARMACOPOEIA CHEMICAL REFERENCE SUBSTANCE


INFORMATION LEAFLET
ADAPALENE IMPURITY STANDARD
CATALOGUE NUMBER 1121
CURRENT BATCH: 4233

Declared Content
No declared content figure is given as the standard is not used for assay purposes.

Use
This British Pharmacopoeia Chemical Reference Substance (BPCRS) is to be used as directed in the
monograph(s) of the British Pharmacopoeia and is not intended for any other purpose.

Reference Chromatogram(s)

50 50

40 40

30 30
mVolts

mVolts

20 20

10 10
Adapalene Impurity D
Adapalene Impurity A

0 0

-10 -10

2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 40.0
Minutes

Version: 01 Last Revised: 30/11/2019 Page 1 of 2


British Pharmacopoeia Commission Secretariat
MHRA, 10 South Colonnade, Canary Wharf
London E14 4PU
United Kingdom

British Pharmacopoeia Commission Laboratory


Queen’s Road
Teddington, TW11 0LY
United Kingdom

www.pharmacopoeia.com
www.pharmacopoeia.com

Column: Supelcosil LC-DB C18, 5 µm (250 x 4.6 mm)


Mobile Phase A: 0.2:100 (Trifluoroacetic acid:Water v/v)
Mobile Phase B: 40:60 (Tetrahydrofuran:Acetonitrile v/v)
Gradient Program:

Time (min) % Mobile Phase A % Mobile Phase B


0 40 60
3 17 83
30 17 83
31 40 60
40 40 60

Diluent: Water:Tetrahydrofuran (50:50 v/v).


Detection: Fluorimetric Detection

Time Excitation Wavelength Emission Wavelength


(min) (nm) (nm)
0 260 380
11 260 347
30 260 347
31 260 380
40 260 380

Flow rate: 1.5 mL/min


Column temperature: 25 °C
Injection Volume: 10 µL
Additional Information
Corrections:
Related substances for Adapalene Cream and Adapalene Gel
For Solution (3), the content of Impurity D in this BPCRS is only 0.3% of the solution and not 0.5% as
stated in the monograph. This is due to a lower amount of Impurity D in this BPCRS. This should be
corrected for when calculating the content of Impurity D in solution (1).

For additional information on BPCRS please visit the British Pharmacopoeia website.
https://www.pharmacopoeia.com

Version: 01 Last Revised: 30/11/2019 Page 2 of 2

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