Product Name: Anhydrous vidarabine

Batch No. : 2301001

Quantity: 300.2kg

Analysis according:  QS-01-050(1)-02

Date of Production:   Jan. 20, 2023

Test Date:  Feb. 01,2023

Date of Report:  Feb. 03,2023

Expiry date:   Jan. 19, 2025

Items

Requirements

Results

(1)

Description

White, tiny needle-shaped crystal or crystalline powder; odourless, tasteless

Complies

(2)

Identification

(1)show positive reaction

Complies

(2)the retention time

complies to standard

(3)max absorption at 259nm;

min absorption at 228nm;

(4)Infrared absorption

(3)

PH

6.0~7.0

6.3

(4)

Transmission

≥98.0%

99.8%

(5)

Relate impurities

≤1.0%

0.1%

(6)

Loss on drying

≤0.5%

0.2%

(7)

Residue on ignition

≤0.1%

0.1%

(8)

Heavy metals

10ppm

Complies

(9)

Specific rotation

-56.0 º ~65.0º

-58.2º

(10)

Assay(HPLC)

98.0%~102.0%

          100.0%

Conclusion:                              Meet the requirement