High quality Valganciclovir Hydrochloride

Items

Acceptance Criteria

（USP36）

Appearance

White or almost white crystalline powder

Identification

A: Infrared absorption

B: Ultraviolet absorption

C: General, chloride

Corresponds to that of reference standard

Corresponds to that of reference standard

Positive

Water

Not more than 8.0%

Residue on ignition

Not more than 0.10%

Heavy metals

Not more than 0.002%

Limit of isopropyl alcohol

Not more than 1.0%

Related compounds (Test 1)

Ganciclovir

Guanine

Methoxymethylguanine

Isovalganciclovir

Monoacetoxyganciclovir

Bis-valine easter of ganciclovir

Homologue of Valganciclovir

Imp. H (RRT1.47)

Imp. I (RRT1.52)

Ganciclovir monopropionate

Valganciclovir dimer

Not more than 1.5%

Not more than 0.25%

Not more than 0.3%

Not more than 0.5%

Not more than 0.15%

Not more than 0.1%

Not more than 0.25%

Not more than 0.1%

Not more than 0.1%

Not more than 0.15%

Not more than 0.1%

Related compounds (Test 2)

Ganciclovir mono-N-methyl valinate

Not more than 0.3%

Unidentified impurity (Test 1 and 2)

Total unidentified impurity  (Test 1 and 2)

Total Impurities (Test 1 and Test 2)

Not more than 0.1%

Not more than 0.25%

Not more than 3.0%

Diastereomer ratio

45:55 to 55:45

Enantiomeric purity of Valganciclovir

Not less than 97.0%

Assay

Not less than 97.0% and not more than 102.0% of C₁₄H₂₂N₆O₅HCl, calculated on the anhydrous and solvent-free basis