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Name of the ingredient
Choline dihydrogen citrate (AAN)
Definition of the ingredient
Molecular formula: C5H14NO · C6H7O7 (Choline dihydrogen citrate)
CAS registry Number: 77-91-8 (Choline dihydrogen citrate)
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | White powder |
| Loss on drying | BP (Appendix IX D) | Not more than 0.5% w/w |
| Solubility | BP (General notice) | Freely soluble in water |
| IR spectrum | BP (Appendix II A) | Complies with authenticated reference material/spectrum |
| Purity | BP (Appendix VIII B) | Not less than 98% |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Microbiology | ||
| While ingredient manufacturers are encouraged to include limits for Incidental metals and non-metals, it is the product into which those substances are formulated that contains the ingredient, alone or in combination with other ingredients, must comply with the acceptance criteria set in the United States Pharmacopeia - National Formulary (USP-NF) general chapter '<2232> Elemental Contaminants in Dietary Supplement'. When testing is performed at the raw material stage, calculation of the total daily exposure in the finished product should be performed. This calculation is based on the quantity of each ingredient present in the product, the maximum potential contamination given the proposed limits for each raw material and the daily dose of the product. | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
BP = British Pharmacopoeia
CAS = Chemical Abstracts Service
USP = United States Pharmacopoeia