Requirements for Injectable Veterinary Drugs

To be specific, Circular 10 stipulates that injectable veterinary drugs must meet the following requirements:

Sensory requirements

- Color: colorless or the color of the active ingredient.

- Dispersed state:- For injectable veterinary drugs in suspension form: the suspension may sediment but must be easily and uniformly dispersed upon shaking and maintain uniformity long enough to ensure the correct dosage administration.- For injectable drugs in emulsion form: the preparation must not show any signs of phase separation.

- Clarity: injectable veterinary drugs in solution form must be clear without any insoluble particles when inspected with the naked eye.

Volume requirements:

- For injectable veterinary drugs in containers smaller than 50ml: the allowable volume deviation is +10% compared to the volume stated on the label.- For injectable veterinary drugs in containers larger than 50ml: the allowable volume deviation is +5% compared to the volume stated on the label.

Sterility requirements:

- No bacteria or mold growth on the culture medium after 14 days of monitoring.

Active ingredient content requirements:

- Qualitative: contains the active ingredient registered and labeled on the product.- Quantitative: the active ingredient content of the product is between 90% to 110% of the content stated on the product label.

For more details, see Circular 10/2018/TT-BNNPTNT effective from February 14, 2019.

-Thao Uyen-

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