質(zhì)量標準: 鑒別 顯鈣鹽及乳酸鹽反應
溶狀(1 20) → 無色澄清
pH 值(1 20) → 6.0~8.0
游離酸和游離堿 通過試驗(BP/EP/JP)
重金屬(以Pb 計),% ≤0.001
砷(以As 計),% ≤0.0002
鋇 通過試驗(EP)
鉛,% ≤0.00003
氟化物,% ≤0.0015
鐵,% ≤0.0025
氯化物,% ≤0.004
硫酸鹽,% ≤0.02
鎂堿鹽,% ≤1.0
揮發(fā)性脂肪酸 通過試驗(USP)
有機揮發(fā)性雜質(zhì) 通過試驗(USP)
干燥失重,% 22.0~27.0
乳酸鈣含量(以干基計),% 99.0~101.0
鈣含量,% 13.1~14.5
光學純度,% ≥96.0
粒度(粉末產(chǎn)品),% ≤150μm ≥95
75~425μm ≥90
粒度(顆粒產(chǎn)品),%
≤500μm ≥98
USP, EP, BP, JP 級
ASSAY (DRIED BASIS) 98.0-101.0%
LOSS ON DRYING 22.0-27.0%
VOLATILE FATTY ACIDS TO PASS TEST
HEAVY METALS -- 10 PPM
LEAD (Pb) -- 2 MG/KG
MAGNESIUM AND ALKALI SALTS -- 1.0%
APPEARANCE OF SOLUTION TO PASS TEST
ACIDITY OR ALKALINITY TO PASS TEST
CHLORIDES -- 200 PPM
SULPHATES -- 400 PPM
BARIUM TO PASS TEST
IRON -- 50 PPM
FLUORIDE -- 0.0015%