Certificate Of Analysis
Item Number
Item
CAS Number
Molecular formula
MA109
Magnesium Carbonate, Heavy, Powder,
USP, EP, BP, JP
23389-33-5
Approx. 4MgCO3.Mg(OH)2.5H2O
Test
Specification
Lot Number
1BC0842
Molecular Weight
Result
min max
ASSAY (MgO)
40.0 - 43.5%
APPEARANCE OF SOLUTION
TO PASS TEST
41.80%
DENSITY (g/cc)
APPRX. 0.5
MICROBIAL ENUMERATION TESTS AND
ABSENCE OF SPECIFIED MICROORGANISMS
TO PASS TEST
SOLUBLE SALTS
1.00%
0.80%
ACID-INSOLUBLE SUBSTANCES
0.05%
0.01%
ARSENIC (As)
2 ppm
<2 ppm
CALCIUM (Ca)
0.43%
0.17%
HEAVY METALS (as Pb)
0.00%
<0.002%
IRON (Fe)
0.02%
0.01%
CHLORIDE (Cl)
700 ppm
SULFATE
0.60%
PRECIPITATION TEST
TO PASS TEST
PASSES TEST
RESIDUAL SOLVENTS
TO PASS TEST
NO RESIDUAL SOLVENTS USED
IDENTIFICATION
TO PASS TEST
PASSES TEST
PASSES TEST
0.5
PASSES TEST
<700 ppm
<0.6 %
EXPIRATION DATE
10-Apr-13
MANUFACTURE DATE
10-Apr-10
APPEARANCE
WHITE POWDER
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
14422 South San Pedro Street
Gardena, 90248 CA