Injectable Drug Quality Control

1. Visual Inspection

• Color:

• Solutions: Colorless or with a characteristic color imparted by the active ingredient. Note: The color should be uniform and consistent with the standard.

• Emulsions: No evidence of layering or phase separation. Note: Shake well before use to ensure homogeneity.

• Suspensions: Sedimentation may occur, but the preparation should disperse immediately upon shaking and maintain uniformity when a sufficient dose is withdrawn. Note: Carefully observe before use, ensuring the sediment is fully dispersed and there are no clumps.

• Powder in vials: Must be dry, free from caking, and easily soluble in the solvent or readily dispersible into a homogeneous suspension. Note: Use sterile solvent and only reconstitute when needed.

• Clarity: Injectable solutions should be clear. Note: If the solution appears cloudy or hazy, it should be carefully examined.

• Uniformity: The injectable preparation should be uniform in color, clarity, and free from any layering or phase separation.

• Sterility: Two methods can be used:

• Direct inoculation: A specified amount of the product is directly inoculated into a suitable culture medium.

• Membrane filtration: The product is diluted appropriately, filtered through a membrane filter, and the filter is cut into small pieces and immersed in a culture medium.

• Particulate matter testing: Visual inspection, automated particle counters, or microscopes. Note: Examination should be performed under suitable lighting, ensuring the absence of extraneous particles and that the particle size is within the acceptable limit.

2. Physicochemical Properties

• pH: Checked with a pH meter. Note: The pH should be within the permissible limits specified in the pharmacopeia.

• Viscosity: Measured using a viscometer. Note: The viscosity should be within the acceptable limits specified in the pharmacopeia.

• Stability: Checked by storing the sample under specified conditions and monitoring changes in color, clarity, pH, viscosity, etc. Note: The injectable preparation must be stable under prescribed storage conditions.

• Volume: Checked with graduated cylinders or other volumetric measuring devices. Note:

• Injectable preparations with a volume ≤ 5 mL have a permissible limit of 100-115% of the volume stated on the label (average volume of 5 vials + 1 vial for syringe priming).

• Injectable preparations with a volume > 5 mL have a permissible limit of 100-110% of the volume stated on the label (average volume of 3 vials + 1 vial for syringe priming).

3. Safety Testing

• Pyrogenicity: Performed for injectable preparations with a dose ≥ 15 mL.

• Rabbit test: Based on the increase in rabbit body temperature after intravenous injection of the test solution.

• Bacterial endotoxins:

• Use the Lysate reagent for testing.

• Permissible limits: Refer to the pharmacopeia standards or regulations of the regulatory body.

Notes:

• Injectable drug quality control must be performed by qualified personnel who are appropriately trained.

• Adhere to pharmacopeia regulations and regulatory guidelines for injectable drug quality control.

• Record test results comprehensively and clearly.

• Utilize advanced quality control methods to ensure accuracy and reliability.

• Store injectable preparations as per regulations after testing.

Additional Information:

• In addition to the aforementioned quality control checks, other properties may need to be tested, depending on the type of injectable preparation, such as active ingredient content, dissolution rate, diffusion rate, etc.

• Injectable drug quality control is crucial to ensure the safety and efficacy of the product for the user.

General Note:

• This article provides only basic information on injectable drug quality control.

• For detailed information, consult specialized literature on injectable drug quality control.