BOC Sciences GMP Products-Adapalene
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<strong>BOC</strong> <strong>Sciences</strong><br />
A division of Creative Dynamics Inc.<br />
T: 631-504-6093 • F: 631-614-7828 • E: info@bocsci.com<br />
45-16 Ramsey Road Shirley, NY 11967, USA • www.bocsci.com<br />
Certificate of Analysis<br />
<strong>Adapalene</strong><br />
CAS 106685-40-9 Batch No. B14X0309<br />
Product Name <strong>Adapalene</strong> Batch size 10kg<br />
MFG. Date Mar. 9, 2014 Retest Date Mar. 8, 2016<br />
TESTING ITEM SPECIFICATION RESULT<br />
Appearance White to off-white powder White powder<br />
Assay 98.0~102.0% 99.4%<br />
Solubility<br />
Practically insoluble in water &<br />
ethanol, sparingly soluble in<br />
tetrahydrofuran<br />
Conforms<br />
Heavy Metals ≤20ppm Conforms<br />
Loss on drying ≤0.5% 0.12%<br />
Tetrahydrofuran<br />
≤ 720ppm<br />
None detected<br />
Residual solvent<br />
Acetic acid<br />
≤ 5000ppm<br />
None detected<br />
Methanol<br />
≤ 3000ppm<br />
None detected<br />
<strong>BOC</strong> <strong>Sciences</strong>. Creative Dynamics Inc. All rights reserved.
<strong>BOC</strong> <strong>Sciences</strong><br />
A division of Creative Dynamics Inc.<br />
T: 631-504-6093 • F: 631-614-7828 • E: info@bocsci.com<br />
45-16 Ramsey Road Shirley, NY 11967, USA • www.bocsci.com<br />
Certificate of Analysis<br />
<strong>Adapalene</strong><br />
TESTING ITEM SPECIFICATION RESULT<br />
Impurity A ≤0.3% 0.22%<br />
Impurity D≤0.2% 0.09%<br />
Relative substance<br />
Impurity C≤0.15% 0.07%<br />
Unknown impurity ≤0.1% 0.05%<br />
Total impurity ≤0.5% 0.46%<br />
QA:<br />
Sharon Lee<br />
QC:<br />
Paulo Park<br />
Date:<br />
Mar. 12, 2014<br />
<strong>BOC</strong> <strong>Sciences</strong>. Creative Dynamics Inc. All rights reserved.
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