You are here

Compositional guideline: Alanylglutamine

4 March 2014

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

Table 1: Ingredient specific requirements
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
Table 2: Incidental constituents
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