Requirements for Veterinary Drugs in Powder Form for Injection

Circular 10 stipulates that injectable veterinary powder drugs must meet the following conditions:

Sensory Requirements: The powder must be dry, loose, not moist, not lumpy, and uniformly colored.

Weight Requirements:

- For injectable veterinary powder drugs with a package unit of less than or equal to 0.5 g: the permissible weight discrepancy limit is ± 10% compared to the weight stated on the label;- For injectable veterinary powder drugs with a package unit greater than 0.5 g and equal to 1.5 g: the permissible weight discrepancy limit is ± 7% compared to the weight stated on the label;- For injectable veterinary powder drugs with a package unit greater than 1.5 g and equal to 6 g: the permissible weight discrepancy limit is ± 5% compared to the weight stated on the label;- For injectable veterinary powder drugs with a package unit greater than 6 g: the permissible weight discrepancy limit is ± 3% compared to the weight stated on the label.

Sterility Requirements: No bacteria or mold should grow on culture mediums during 14 days of observation.

Active Ingredient Content Requirements:

- Qualitative Analysis: Contains the active ingredient registered and stated on the product label- Quantitative Analysis: The active ingredient content of the product must range from 90% to 110% of the content stated on the product label

Note: Injectable veterinary powder drugs, once mixed with a specified volume of an appropriate sterile liquid immediately prior to use, must meet the quality standards for injectable drugs as defined in this Regulation.

Circular 10/2018/TT-BNNPTNT takes effect from February 14, 2019.

-Thao Uyen-

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