|
Product Name |
Lactose Monohydrate |
Manufacturing Date |
Mar. 18, 2022 |
|
Batch No. |
LME20220301 |
Expiration Date |
Mar. 17, 2024 |
|
Batch Quantity |
1000kg |
Certificate Date |
Apr. 18, 2022 |
|
Test Standard |
Chinese Pharmacopoeia |
Excipient |
None |
|
Storage |
Stroe in a well-closed container away from moisture and direct sunlight. |
||
|
Test Items |
Test Standards |
Test Result(s) |
|
Characters Appearance Solubility Optical Rotation Identification (1) HPLC (2) IR Test Clarity of Solution Alkalinity Acidity Loss in Drying Waters Related Substances Residue in Ignition Arsenic Salt Absorbance of protein and impurities
Heavy Metals Lead Arsenic Mercur Cadmium Assay Contents Microbiological Tests TAMC TYMC Escherichia Coli Salmonella Bile-Tolerant Gram-Negative Bacteria Pseudomonas Aeruginosa Staphylococcus Aureus |
White to off-white crystalline grain or powder Dissolve in water, almost insoluble in ethanol. +54.4°+55.9°
The retention time of the main peak is similarity Spectral is similarity
Complies to standard Complies to standard ≤1.0% ≤4.5%~5.5% ≤0.5% ≤0.1% ≤0.0002% ≤0.04@400nm ≤0.25@210~220nm ≤0.07@270~300nm ≤5ppm ≤3.0ppm ≤1.0ppm ≤0.1ppm ≤1.0ppm
98.0%~102.0%
≤1000CFU/g ≤100CFU/g Absence/g Absence/10g ≤100CFU/g Absence/g Absence/g |
Complies Complies +55.5°
Complies Complies
Complies Complies 0.3% 4.9% Complies 0.01% ＜0.0002% 0.03 0.07 0.03 ＜5ppm Complies Complies Complies Complies
99.7%
＜10CFU/g ＜10CFU/g Absence/g Absence/10g ＜10CFU/g Absence/g Absence/g |
|
Result(s): Results conform to standards. |
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