Vitamin D3 (Cholecalciferol 100 000 IU/g)
Miasto: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Physical & Chemical Characteristics
Analysis Item | Specification | Test Method | Result |
Description | White to light yellow powder, no foreign objects visible, no foreign matter and no odor. | Visual | Complies |
Identification | Retention time conforms to reference solution | HPLC | Complies |
Particle Size | 100% pass through sieve 40 mesh Min.90% pass through sieve 80 mesh | USP<786> / Ph.Eur.2.9.12 | 100% / 99.5% |
Vitamin D3 Assay | ≥100,000 IU/g | HPLC | 111,000 IU/g |
Loss on drying | ≤5.0>% | USP<731> / Ph.Eur.2.2.32 | 4.8% |
Heavy Metals
Analysis Item | Specification | Test Method | Result |
Heavy Metals (as Pb) | ≤10.00 ppm | USP<231>Ⅱ / Ph.Eur.2.4.8 | Complies |
Lead (Pb) | ≤2.00 ppm | USP<251> / Ph.Eur.2.4.10 | <0.05 ppm |
Arsenic (As) | ≤2.00 ppm | USP<211>Ⅱ / Ph.Eur.2.4.2 | 0.01 ppm |
Cadmium (Cd) | ≤1.00 ppm | USP<233> | / |
Mercury (Hg) | ≤0.10 ppm | USP<233> | / |
Microbiological Tests
Analysis Item | Specification | Test Method | Result |
Total aerobic microbial count | ≤1000 CFU/g | USP<2021> Ph.Eur.2.6.12 | 10 CFU/g |
Total moulds and yeasts | ≤100 CFU/g | USP<2021> Ph.Eur.2.6.12 | <10 CFU/g |
Enterobacterial | ≤10 CFU/g | USP<2021> / Ph.Eur.2.6.13 | <10 CFU/g |
Escherichia coli | n.d.10g | USP<2022> / Ph.Eur.2.6.13 | / |
Salmonella | n.d.25g | USP<2022> / Ph.Eur.2.6.13 | / |
Staphylococcus aureus | n.d.10g | USP<2022> / Ph.Eur.2.6.13 | / |
Remarks:
1. Store in a sealed, dark, and dry place (recommended storage temperature below 25℃).
2. Analyzed as per six months.
3. The products in this report are in compliance with export health standards and are for export use only!