Pharma Grade Ergocalciferol Vitamin D2 40miu/G
Description:A white or slightly yellowish, crystalline powder or white or almost white crystals.
Solubility:Freely soluble in ethanol (96 per cent) and in methanol ,soluble in fatty oils. practically insoluble in water.
Assay:96.5%-102.0% of C28H44O.
CERTIFICATE OF ANALYSIS
| Items | Specifications | Results | Methods |
| Description | White to light yellow powder, no foreign matter and no odor. | Complies | Visual |
| Identification | The retention time of the principal peak conforms to which in the reference solution | Complies | HPLC |
| Particle Size |
100% pass through sieve 40 mesh 95% pass through sieve 80 mesh |
100% 99.5% |
USP<786> Ph.Eur.2.9.12 |
| Vitamin D2 Assay | ≥100,000iu/g | 108,500iu/g | HPLC |
| Loss on drying | ≤5.0% | 4.65% |
USP<731> Ph.Eur.2.2.32 |
| Heavy Metals (as Pb) | ≤10.00ppm | <0.06ppm |
USP<231>Ⅱ Ph.Eur.2.4.8 |
| Arsenic (as As) | ≤2.00ppm | <0.4ppm |
USP<211>Ⅱ Ph.Eur.2.4.2 |
|
Total aerobic microbial count Total moulds and yeasts count |
≤1000cfu/g
≤100cfu/g |
100cfu/g
<10cfu/g |
USP<2021> Ph.Eur.2.6.12 |
| Enterobacterial | ≤10cfu/g | <10cfu/g |
USP<2021> Ph.Eur.2.6.13 |
|
*Salmonella *Escherichia coil *Staphylococcus aureus |
n.d./25g n.d./10g n.d./10g |
/ / / |
USP<2022> Ph.Eur.2.6.13 |
| Conclusion: Conform to USP/EP | |||
|
Remarks: 1.* Analyzed as per six batches, not less than once per year. 2. Store at the temperature below 15°C. |
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