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.