Name of the ingredient
POLAPREZINC (AAN)
Definition of the ingredient
Zinc L-carnosine
Molecular formula: C9H12N4O3Zn
Molecular mass: 289.61
CAS Number: 107667-60-7
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White to pale yellow crystalline powder |
| Characteristics | ||
| Solubility | BP (General notices) | Soluble in dilute hydrochloric acid, dilute nitric acid and sodium hydroxide TS; slightly soluble in acetic acid; practically insoluble in water, methanol, ethanol and ether |
| Water | BP (Volume V, Appendix IX C.) | Not more than 5.0% w/w |
| Appearance of solution 1% w/w aqueous solution) | BP (Volume V, Appendix IV A.) | Clear and colourless |
| Identification | ||
| POLAPREZINC | IR spectroscopy BP (Volume V, Appendix II A.) | Complies with authenticated reference material |
| Specific optical rotation (2% w/w in water, 20 °C) | BP (Volume 5, Appendix V F.) | + 8.0° to + 9.0° |
| L-carnosine | Qualitative test (Colorimetric method, based on Biochem J.,1922; 16(5): 640-54) | Complies |
| Zinc | Qualitative reaction (BP Appendix VI) | Complies |
| Assay | ||
| L-carnosine | Potentiometric Titration (BP Volume V, Appendix VIII B) | 76.0% - 80.0% w/w on dried basis |
| Zinc | Complexometric titration (BP Volume V, Appendix VIII D) | 21.5% - 23.0% w/w on dried basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Residual solvents | BP (Appendix VIII L) | Complies |
| 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 general chapter '<2232> Elemental Contaminants in Dietary Supplements'. 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. | ||
| Other organic or inorganic impurities or toxins | ||
| Related substances | BP General Notices for 'Substances for Pharmaceutical use (Ph. Eur. monograph 2034)' | Complies |
| 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. | ||
Key to abbreviations
BP = British Pharmacopoeia
IR = Infrared spectrophotometry
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