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Glycine
CERTIFICATE OF ANALYSIS
Analysis number: 20090369
Product: Glycine, pharmaceutical grade
Date of manufacture: 10/30/2009
Date of analysis: 11/07/2009
Batch number: 200910301
Reference standard: EP VI
The product passes all EP VI specifications using EP VI test methods, the following is our conclusion analysis.
Specifications:
Item Standard Conclusion of analysis
Description white crystals or crystalline powder white crystalline powder
Identification meets the requirements meets the requirements
Appearance of solution clear and≤Y7 conforms
pH 5.9~6.4 6.3
Chloride not more than 0.0075% less than 0.0075%
Heavy metals not more than 0.001% less than 0.001%
Loss on drying not more than 0.5% 0.10%
Sulphated ash not more than 0.1% 0.08%
Residual solvents meet the requirements meet the requirements
Ninhydrin-positive substances ≤0.5% conforms
Assay 98.5%~101.5% 99.0%
Glycine packing: 25kgs/bag
Glycine