Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
Name of the ingredient
Alanylglutamine (AAN)
Definition of the ingredient
N(2)-L-alanyl-L-glutamine
Molecular formula: C8H15N3O4
Molecular mass: 217.2
CAS Number: 39537-23-0
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | White crystalline powder |
| Characteristics | ||
| Solubility | BP General Notices | Very soluble in water |
| Appearance of solution (5% w/v in water) | Ph Eur methods 2.2.1 and 2.2.2 (Method II) | Clear and colourless |
| pH (1M aqueous solution) | Ph Eur method 2.2.3 | 5.4 - 6.0 |
| Loss on drying (105°C/3 hr) | Ph Eur method 2.2.32 | Not more than 0.5% w/w |
| Identification | ||
| IR spectroscopy | Ph. Eur. method 2.2.24 | Complies with authenticated reference material. |
| Specific optical rotation (dry, 10 % w/v in water) | Ph Eur method 2.2.7 | + 9.0° to +11.0° |
| Assay | ||
| Assay | Titration | 98.0 - 102.0% w/w, on dried basis |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual Solvents | ||
| Residual solvents | Ph Eur method 2.4.24 and BP Appendix SC IV D | Complies |
| Incidental metals and non-metals | ||
| Heavy metals (as lead) | Ph. Eur. method 2.4.8 | Not more than 5 ppm |
| Arsenic | Ph. Eur. method 2.4.2 | Not more than 1 ppm |
| Other organic or inorganic impurities or toxins | ||
| Ammonium | Ph. Eur. method 2.4.1 | Not more than 0.02% w/w |
| Chlorides | Ph. Eur. method 2.4.4 | Not more than 0.02% w/w |
| Sulphates | Ph. Eur. method 2.4.13 | Not more than 0.02% w/w |
| Sulphated ash | Ph. Eur. method 2.4.14 | Not more than 0.1% w/w |
| Related substances | HPLC |
Any individual impurity not more than 0.15%w/w. Total impurities not more than 0.5%w/w |
| 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
HPLC = High performance liquid chromatography
IR = Infrared
Ph Eur = European Pharmacopoeia