RISPERIDONE LUPIN risperidone 1 mg/mL oral liquid solution bottle, Generic Health Pty Ltd, CON-1167
Product name
RISPERIDONE LUPIN risperidone 1 mg/mL oral liquid solution bottle
Sponsor name
Generic Health Pty Ltd
Consent start
Consent no.
CON-1167
Standard
pH limit range of United States Pharmacopoeia
Non-compliance with standard
The drug product expiry specifications state a pH limit range of pH 1.65 '“
1.95. 'The Risperidone Oral Solution (British Pharmacopoeia 2024) monograph
specifies a pH limit of 2.0 '“ 4.0. 'The Risperidone Oral Solution (United States
Pharmacopoeia 2023) monograph also specifies a pH limit of 2.0 '“ 4.0.
Conditions imposed
The pH of the risperidone oral solution is in the range 1.65 '“ 1.95
Therapeutic product type
Prescription medicines