product name: VALACYCLOVIR HYDROCHLORIDE

Date of report :Mar.15, 2023

Batch No. : 20230301

Analytical Report Number : 20230301

Batch Size :125Kg

Retest Date :Mar.14, 2025

Mfg. Date : Mar 14, 2023

Page No. :01 of 01

Quality Standard : CP2015

Test

Specification

Observation

Description

A white or almost white crystalline powder, hygroscopic.

White crystalline powder

Solubility

Freely soluble in water;very slightly soluble in ethanol; practically  insoluble in trichlormethane

Conforms

Identification

IR:The IR spectrum is concordant with the reference spectrum of valacyclovir hydrochloride;

UV: The UV spectrum of test solution in 0.01 M solution of  hydrochloric acid in range from 210 to 340 nm has the absorption maximum at 254 nm±2nm,absorption minimum at 224 nm±2nm and shoulder in range from 266 to 286 nm; chlorides reaction:The aqueous solution yields the reactions characteristic of chlorides;

HPLC: According to the chromatogram recorded in the Assay item, the retention time of the major peak of test solution is corresponding to the retention time of the major peak of reference solution.

Conforms

Conforms

conforms

Water content by KF

Not more than 8 %

5.0%

Residue on ignition

Not more than 0.10 %

0.04%

Heavy Metals

Not more than 20 ppm

Conforms

Specific optical rotation [a]D25

 - 8.5°~-11.5°

-9.1°

pH

4.0~6.0

pH 4.2

Specific absorption index

From 336 to 372 at 254 nm (on anhydrous and organic solventless basis)

conforms

Related substances by HPLC

Acyclovir impurity — Not more than 1.00 %

Single individual impurity — Not more than 0.2 %

Total impurities (Remove ACV) — Not more than 0.50 %

0.50%

0.07%

0.11%

Assay

I:By HPLC

Not less than 98.0 % and not more than 102.0%(on anhydrous basis and organic solventless basis)

IL Titrimetry

Not less than 98.0 % not more than 102.0%(on anhydrous and organic solventloss basis）

99.4%

Residual solvents

Ethanol — Not more than 5000ppm

Dimethyl formamide-Not more than 880 ppm

1000ppm     

Not detected