JP 6.06 Foreign Insoluble Matter Test for Injections

An official visual inspection method to examine injections for readily detectable foreign insoluble matter (visible particles).Under JP General Tests (6.06), Injections and attached vehicles must meet this test unless otherwise specified.

JP 6.06 is harmonized with USP <790> and Ph. Eur. 2.9.20 under the Pharmacopoeial Discussion Group (PDG), ensuring globally aligned requirements for visible particle testing in parenteral preparations.

Applies to solutions, emulsions, suspensions, and vehicles for solid injections (Method 1), and to solid injections after reconstitution (Method 2).

Inspection is performed with the unaided eye under reference conditions:

• View against both a white and a black background, ~5 s each.

• Illuminance: 2000–3750 lx under a white light source.

• For plastic containers for aqueous injections: inspect at ~8000–10,000 lx with a white light source positioned above and below the container; extend time if inspection is difficult.

• Method in brief

• Method 1: Clean container exterior; inspect contents per the conditions above. The product must be free from readily detectable foreign insoluble matter. For plastic containers (aqueous injections), use the higher illuminance condition described.

• Method 2 (reconstituted solids): Dissolve/suspend contents with attached vehicle or Water for Injection, avoiding contamination; inspect the resulting solution under the same white/black background and 2000–3750 lx conditions
  • The preparation meets the requirement if no readily detectable foreign insoluble matter is observed under the defined conditions.