Page 68 - Pharmaceutics IV (02-06-01305)

Parenterals: Excipients & additives pH

• pH considerations:
➢ Injectable products should have a pH value between 3.0 and

9.0. pH values above or below this range are too corrosive and

will cause tissue damage at the site of injection.
➢ In case of a low buffering capacity, a low injection volume, a slow

injection rate and a nonirritating active drug substance, even an

extreme pH (high or low) can be locally well tolerated without

irritation.

129

Parenterals: Excipients & additives

pH

• pH considerations:
➢ Parenteral products administered by the intrathecal, epidural,

intracisternal and intraocular routes must be formulated at
physiological pH.
➢ For subcutaneous injections, more restrictive pH ranges such as
5.5-8.5 are suggested, to avoid any risk of tissue damage.

130 65

Salma E. EL-Habashy