No. 158 Xintuan Road, Qingpu Industrial Zone, Shanghal 201707 China
o% 25 SHANGHAI KYOWA AMINO ACID CO.,LTD.
KYOWA Phone: 86-21-5970-1998 Fax: 86-21-5970-1135
TE OF
Commodity: L-SERINE
Lot No: 19020775
Manufacturing date: Feb-24-2019
Analysis date: Apr-16-2019
Retest date: Feb-24-2022
‘SPECIFICATION ‘ACCEPTANCE CRITERIA RESULT
"APPEARANCE WHITE CRYSTALS OF WHITE CRYSTALS
(CRYSTALLINE POWDER
IDENTIFICATION (} PASS TEST PASS TEST
STATEOF SOLUTION COLORLESS AND CLEAR, COLORLESS AND CLEAR
STATEOF SOLUTION (1%) NOT LESS THAN 98 0% 100.0%
@:. 282 28
SPECIFIC ROTATION (AT20°C ) td ~ 155 4g"
SPECIFIC ROTATION (AT25°C ) +40 ~ +156" age
AMMONIUM (NH«) NOT MORE THAN 0.020% NOT MORE THAN 0.020%
(CHLORIDE (CI) NOT MORE THAN 0.020% NOT MORE THAN 0.020%
SULFATE (S01) NOT MORE THAN 0.020% NOT MORE THAN 0.020%
IRON (Fe) NOT MORE THAN 1Oppm NOT MORE THAN Open
HEAVY METALS (es Pb) NOT MORE THAN Sppm NOT MORE THAN Sppm
ARSENIC. (AS20) NOT MORE THAN ppm NOT MORE THAN ppm
LOS ON DRYING NOT MORE THAN 0.20% 001%
RESIDUE ON IGNITION NOT MORE THAN 0.10% 0.02%
RELATED SUBSTANCES
UNSPECIFIED IMPURITY NOT MORE THAN 0.2% 00%
TOTAL IMPURITIES NOT MORE THAN 05% 0%
ASSAY (ORY BASIS) 980 ~ 101.0% 97%
e TOTAL AEROBIC MICROBIAL COUNT NOT MORE THAN 100 CFUIg NOT MORE THAN 100 CFU/g
‘TOTAL YEASTS AND MOULDS COUNT NOT MORE THAN 10 CFUIg NOT MORE THAN 10 CFU/g
ECOu NEGATIVE!Q NEGATIVE!g
ENDOTOXIN LESS THAN 3 0EUlg LESS THAN 3 0EUlg
THIS SPECIFICATION MEETS THE CURRENT CP, JP, USP AND EP PRODUCT MONOGRAPHS AND
‘THE CURRENT RESIDUAL SOLVENTS REQUIREMENT AS PER USP AND EP.
NO ANIMAL ORIGIN RAW MATERIALSIADDITIVES ARE USED THROUGHOUT THE MANUFACTURING
PROCESS.
MADE IN CHINA,
“The undersigned affirms that contents mentioned above are truly reported in accordance with the analysis by Qualty Control
Department
Date ofissue: Jun-20-2019 ‘QA Manager