RAW MATERIAL ANALYSIS REPORT
Chemical Name: ATROPINE SULFATE?? ????????????RM
Control No.:__________
Supplier:___________________________??????????????????Qty.
Received:____________
Lot No.:___________________________??????????????????Date
Received:___________
Expiry Date:_______________________
|
PARAMETERS
USP
|
STANDARD
|
RESULT
|
REMARKS
|
|
Description
|
Colourless
crystals or white, crystalline powder. Odourless.
|
|
|
|
Solubility
|
Very
soluble in water; freely soluble in alcohol and even more so in boiling
alcohol; freely soluble in glycerin.
|
|
|
|
Identification
|
A: Infrared absorption
<197K>
B: A solution (1 in 20) meets
the requirements of the tests for sulfate<191>
|
|
|
|
Melting
temperature
|
Not
lower than 187?, determined after drying at 120?for 4 hours.
|
|
|
|
Acidity
|
:Not
more than 0.30 mL is required to produce a yellow colour.
|
|
|
|
Water
Method I <467>
|
Not
more than 4.0%
|
|
|
|
Residue
on ignition
|
Not
more than 0.2%.
|
|
|
|
Organic
volatile impurities Method I <467>
|
Meets
the requirements
|
|
|
|
Other
alkaloids
|
A
slight opalescence may develop but no turbidity is produced
|
|
|
|
Assay
|
Not
less than 98.5% and not more than 101.0% of (C17H23NO3)2
. H2SO4 calculated on the anhydrous basis
|
|
|
QC DISPOSITION:??[????? ]?PASSED??????????????????[
?????]?REJECT
Analyzed by:_____________________????????????Reviewed
by:______________________
Date:___________________________????????????Date:____________________________
Revised: February, 2006??????????? ????????????Approved
By:_____________________
