Certificate Of Analysis
Item Number
Item
CAS Number
Molecular formula
AL300
Aluminum Sulfate, USP
17927-65-0
Al2(SO4)3.xH2O
Test
Specification
Lot Number
2BB0170
Molecular Weight
342.15 + XH2O
Result
min max
ASSAY [Al2(SO4)3]
54.0 - 59.0 %
pH OF A 1 IN 20 SOLUTION
2.9
WATER
41.0 - 46.0 %
ALKALIES AND ALKALINE EARTHS
0.40%
AMMONIUM SALTS
TO PASS TEST
HEAVY METALS
20 ug/g
IRON (Fe)
TO PASS TEST
PASSES TEST
IDENTIFICATION
TO PASS TEST
PASSES TEST
RETEST DATE
RESIDUAL SOLVENTS
APPEARANCE
DATE OF MANUFACTURE
DATE OF RE-ANALYSIS
55.70%
3.4
45.60%
0.36%
PASSES TEST
< 20 ug/g
31-Aug-14
TO PASS TEST
NO RESIDUAL SOLVENTS USED
WHITE POWDER
1-Oct-09
19-Aug-11
RESIDUAL SOLVENTS: USP, Chapter 467 limits the residual solvent content of a drug product to the permitted daily exposure (PDE)
level given in that chapter. This Spectrum Certificate of Analysis reports any residual solvents that are likely to be present in the material
as a result of manufacturing and/or processing. Residual solvents of Class 1 are identified and quantified when present in the material.
Residual solvents of Class 2 or Class 3 are identified and the maximum limit is reported unless Class 2 solvents are present at levels
greater than Option 1 limits or Class 3 solvents are present at levels greater than 0.5%. It is the responsibility of the producer of a finished
dosage form to ensure that the aggregate residual solvent content meets applicable requirements set forth in USP, Chapter 467.
Spectrum Chemical Mfg Corp
755 Jersey Avenue
New Brunswick, 08901 NJ