Choline Chloride, USP Dietary Supplement, 99%, 1KG
$405.95
- Medex SKU:
- SPC-C2058-1KG
- Packing Info:
- 1/Each
- Usually Ships:
- 3 - 5 Business Days
Description
Choline Chloride, USP Dietary Supplement. Spectrum Chemical graded products (USP/NF, EP, BP, JP, FCC) are handled, packaged, labeled, stored, and tested in FDA registered and inspected facilities. All operations are conducted in compliance with current Good Manufacturing Practices (cGMP) as defined in 21 CFR Parts 210 and 211. Furthermore, the original manufacturers of these materials adhere to appropriate GMP standards, such as ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients or FDA 21 CFR Parts 210 and 211, ensuring the highest quality and regulatory
| TEST | MIN | MAX |
|---|---|---|
| APPEARANCE | ||
| ASSAY (ANHYDROUS BASIS) | 99.0 | 100.5 % |
| pH | 4.0 | 7.0 |
| ARSENIC | 2 ppm | |
| LEAD | 0.3 ppm | |
| WATER DETERMINATION | 0.5 % | |
| RESIDUE ON IGNITION | 0.05 % | |
| LIMIT OF TOTAL AMINES | 10 μg/g | |
| LIMIT OF 1,4-DIOXANE (USP) | 10 μg/g | |
| CHROMATOGRAPHIC PURITY : | ||
| INDIVIDUAL IMPURITIES | 0.3 % | |
| TOTAL IMPURITIES | 2.0 % | |
| ELEMENTAL IMPURITIES | AS REPORTED | |
| IDENTIFICATION (A) | SPECTRUM MATCHES REFERENCE | |
| IDENTIFICATION (B) | POSITIVE FOR CHLORIDE | |
| CERTIFIED KOSHER | ||
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| MONOGRAPH EDITION | ||
| RESIDUAL SOLVENTS | AS REPORTED |