Alanylglutamine

Compositional guideline for 'Alanylglutamine' permitted for use in listed medicines

Last updated

4 March 2014

Name of the ingredient

Alanylglutamine (AAN)

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
Characteristics
Identification
Assay
Appearance	Visual	White crystalline powder
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
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	Titration	98.0 - 102.0% w/w, on dried basis

Table 2: Incidental constituents
Test	Method reference	Acceptance criteria
Residual Solvents
Incidental metals and non-metals
Other organic or inorganic impurities or toxins
Microbiology
Residual solvents	Ph Eur method 2.4.24 and BP Appendix SC IV D	Complies
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
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
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

HPLC = High performance liquid chromatography

IR = Infrared

Ph Eur = European Pharmacopoeia

Product types