T/CVDA 1-2023 Active Group standards

T/CVDA 1-2023 Pig vaccine with capsicum adjuvant

Publish Date: 2024-02-01 Implement Date: 2024-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CVDA 1-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Veterinary drugs and livestock farming, veterinary equipment

ICS Name: Veterinary medicine

Publish Date: 2024-02-01

Implement Date: 2024-02-01

Scope

Scope: This standard specifies the technical requirements, testing methods, inspection rules, labeling, packaging, storage, transportation, and shelf life of squalene adjuvants for swine vaccines. This standard applies to water-soluble nanoimmunoadjuvants primarily made from squalene/squalane as the main raw material, supplemented with suitable additives. Main Technical Content: 5. Usage and Dosage: Mainly applicable to aqueous swine vaccines. Mix with the aqueous antigen at a ratio of 1:1 (by volume) and stir at 200 r/min for 5-10 minutes. 6. Physical and Chemical Indicators and Testing Methods 6.1 Appearance: Take an appropriate amount of the product and place it in a colorless transparent container. Under conditions of no direct sunlight, the appearance should be a milky white homogeneous liquid. 6.2 pH Value: Take an appropriate amount of the product and determine the pH value according to the "People's Republic of China Pharmacopoeia (2020 Edition)" (III) Appendix 3101 "pH Determination Method". It should be within the range of 6.0-7.0. 6.3 Particle Size 6.3.1 Average Particle Size: Take an appropriate amount of the product and determine the average particle size according to the "People's Republic of China Pharmacopoeia (2020 Edition)" (I) General Principle 0982 "Particle Size and Particle Size Distribution Determination Method" by light scattering. The average particle size should be within the range of 155±20 nm. 6.3.2 Large Particle Count: Take an appropriate amount of the product and determine the number of large particles (diameter ≥ 1.2μm) according to the "People's Republic of China Pharmacopoeia (2020 Edition)" (I) General Principle 0982 "Particle Size and Particle Size Distribution Determination Method" by light scattering. The number of large particles should not exceed 1×107 particles/mL. 6.4 Squalene Content: Determine the squalene content according to the "People's Republic of China Pharmacopoeia (2020 Edition)" (I) General Principle 0512 "High-