On August 14, 2018, the Ministry of Agriculture and Rural Development issued Circular 10/2018/TT-BNNPTNT, specifically stipulating the requirements for veterinary drugs in tablet form.
To be specific:, veterinary medicine in tablet form must meet the following requirements:
Sensory requirements: Solid tablets, smooth on both sides, may have grooves, letters, or symbols on its surface. The edges and body of the tablet must be intact.
Disintegration requirements: The disintegration time of the medicine must not exceed 15 minutes in water for uncoated tablets, not exceed 30 minutes in water for film-coated tablets, and not exceed 60 minutes in water for other coated tablets.
Weight requirements:- For veterinary medicine tablets with a packaging unit less than or equal to 80 mg: the allowable weight deviation limit is ± 10% compared to the weight stated on the label;- For veterinary medicine tablets with a packaging unit greater than 80 mg and less than 250 mg: the allowable weight deviation limit is ± 7.5% compared to the weight stated on the label;- For veterinary medicine tablets with a packaging unit greater than 250 mg: the allowable weight deviation limit is ± 5% compared to the weight stated on the label.
Active ingredient content requirements:
Active ingredient requirements are regulated in Circular 110, including qualitative and quantitative criteria. To be specific::
- Qualitative: Contains the active ingredient registered and stated on the product label.- Quantitative: The active ingredient content of the product ranges from 90% to 110% compared to the content stated on the product label.
For more details, refer to Circular 10/2018/TT-BNNPTNT effective from February 14, 2019.
-Thao Uyen-
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