DOMINION VETERINARY
LABORATORIES LTD.
QUALITY CONTROL DEPARTMENT
RAW MATERIAL ANALYSIS
REPORT?b style='mso-bidi-font-weight:normal'>70R-DEXAM
Chemical Name: DEXAMETHASONE BASE????????? RM Control No.:__________
Supplier: __________________________???????????????Qty.
Received:____________
Lot No.: ___________________________??????????????Date
Received:____________
Expiry Date:________________________
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PARAMETERS
USP
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SPECIFICATION
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RESULT
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REMARKS
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Description
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White to practically white, odorless, crystalline
powder. Stable in air
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Solubility
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Practically insoluble in water; sparingly soluble
in acetone, in alcohol, in dioxane, and in methanol; slightly soluble in
chloroform; very slightly soluble in ether
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Identification
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A.
Infrared Absorption <197K>
B.
Ultraviolet Absorption <197U>: do not differ by more than 3.0%
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Specific
rotation <781S>
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Between +72?and +80?o:p>
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Loss on drying
<731>
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It loses not more than 0.5 % of its weight.
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Residue
on ignition <281>
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Not more than 0.2% from 250 mg.
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Chromatographic purity
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Not more than 1.0% of any individual impurity is
found, and not more than 2.0% of total impurities is found
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Organic
volatile impurities Method IV <467>
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Meets the requirements
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Assay <621>
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Not
less than 97.0% and not more than 102.0% of C22H29FO5
calculated on the dry basis
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QC DISPOSITION: ??????? [????? ]?PASSED?????????[????? ]
REJECT
Analyzed by:_____________________??????????? Noted
by:______________________
Date:___________________________???????????Date:_________________________
Revised: October, 2005 GAM?????????????Approved By:___________________????????????
