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QUANTITY : 100KGS
PACKING : 25KG DRUM
BATCH NO. : 20144019
MANUFACTURE DATE : APR, 2014
EXPIRY DATE : APR, 2017
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ITEMS SPECIFICATIONS RESULTS
APPEARANCE White crystalline powder Conform
IDENTIFICATION A. IR Conform
B. HPLC Conform
C. TLC Conform
HYDROLYSIS PRODUCTS TLC Conform
RELATED SUBSTANCE TLC Conform
WATER (KF) ≤2.0% 0.4%
HEAVY metaLS (as Pb ) ≤10PPM <10PPM
LEAD ≤1MG/KG Conform
RESIDUE ON IGNITION ≤0.7% <0.7%
SPECIFIC ROTATION Between +84.0* to +87.5* +86.9 *
METHANOL ≤0.1% <0.1%
ASSAY ≥ 99.0% --102.0% 99.60%
PH OF 10% AQUCOUS SOLUTION 5-8 6.7
ARSENIC ≤3PPM <3PPM
CONCLUSION: IN CONFORMITY WITH FCCVI/USP31 .
