Specification | ||
Test Item | Specification | Test Method |
Appearance | Pale yellow powder,no odor and no foreign matter. | Visual |
Identification | The retention time of the principal peak conforms to which in the reference solution. | HPLC |
Particle Size | 100% pass through sieve 40 mesh Min.90% pass through sieve 80 mesh | USP<786> Ph.Eur.2.9.12 |
Vitamin A Acetate Assay | Minimum 325,000IU/g | HPLC |
Loss on drying | Maximum 5.0% | USP<731> Ph.Eur.2.2.32 |
Heavy Metals | Maximum10ppm | USP<231> Ph.Eur.2.4.8 |
Lead | Maximum 2ppm | USP<251> Ph.Eur.2.4.10 |
Arsenic | Maximum 2ppm | USP<211> Ph.Eur.2.4.2 |
Cadmium | Maximum 1ppm | USP<233> |
Mercury | Maximum 0.1ppm | USP<233> |
Total aerobic microbial count | Maximum 1000 cfu/g | USP<2021> Ph.Eur.2.6.12 |
Moulds and yeast | Maximum100 cfu/g | USP<2021> Ph.Eur.2.6.12 |
Enterobacterial | Maximum10 cfu/g | USP<2021> Ph.Eur.2.6.13 |
Escherichia coli | Negative/10g | USP<2022> Ph.Eur.2.6.13 |
Salmonella | Negative/10g | USP<2022> Ph.Eur.2.6.13 |