Choline dihydrogen citrate

Compositional guideline for 'Choline dihydrogen citrate' permitted for use in listed medicines

Last updated

21 September 2015

Name of the ingredient

Choline dihydrogen citrate (AAN)

Molecular formula: C₅H₁₄NO · C₆H₇O₇ (Choline dihydrogen citrate)

CAS registry Number: 77-91-8 (Choline dihydrogen citrate)

Table 1. Ingredient specific requirements
Test	Method reference	Acceptance criteria
Description
Appearance	Visual	White powder
Characteristics
Loss on drying	BP (Appendix IX D)	Not more than 0.5% w/w
Solubility	BP (General notice)	Freely soluble in water
Identification
IR spectrum	BP (Appendix II A)	Complies with authenticated reference material/spectrum
Assay
Purity	BP (Appendix VIII B)	Not less than 98%

Table 2. Incidental constituents
Test	Method reference	Acceptance criteria
Incidental metals and non-metals
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.
Microbiology
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.

BP = British Pharmacopoeia

CAS = Chemical Abstracts Service

USP = United States Pharmacopoeia

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