Document ID: chunk:federal_register_of_legislation:F2025C00151:body:0:p6
Version: federal_register_of_legislation:F2025C00151
Segment Type: other
Provision Reference: 
Character Range: 17416–20510

solubility—freely soluble in water; very slightly soluble in alcohol.
Adenosine-5′-monophosphate (AMP)
 (2) For adenosine-5′-monophosphate (AMP), the specifications are the following:
 (a) empirical chemical formula—C10H14N5O7P;
 (b) the compound must be of the 5 species, with the monophosphate structure attached to the fifth carbon in the central structure;
 (c) molecular weight—347.22;
 (d) structure or physical character—occurs as a colourless or white crystal or as a white crystalline powder. It is odourless and has a characteristic acidic taste;
 (e) solubility—very slightly soluble in water; practically insoluble in alcohol.
Cytidine-5′-monophosphate (CMP)
 (3) For cytidine-5′-monophosphate (CMP), the specifications are the following:
 (a) empirical chemical formula—C9H14N3O8P;
 (b) the compound must be of the 5 species, with the monophosphate structure attached to the fifth carbon in the central structure;
 (c) molecular weight—323.20;
 (d) structure or physical character—occurs as a colourless or white crystal or as a white crystalline powder. It is odourless and has a characteristic slightly acidic taste;
 (e) solubility—very slightly soluble in water; practically insoluble in alcohol.
S3—18 Testing requirements for nucleotides
  The testing requirements for nucleotides are as follows:
 (a) physical inspection—white crystals or crystalline powder;
 (b) identification:
 (i) ultraviolet absorbance: a 1 in 12 500 solution of the powder in 0.01N hydrochloric acid exhibits an absorbance maximum at an absorbance of:
 (A) for inosine-5′-monophosphate disodium salt—250 ± 2nm; and
 (B) for uridine-5′-monophosphate disodium salt—260 ± 2nm; and
 (C) for adenosine-5′-monophosphate—257 ± 2nm; and
 (D) for cytidine-5′-monophosphate (CMP)—280 ± 2nm; and
 (E) guanosine-5′-monophosphate disodium salt (gMP)—256 ± 2nm; and
 (ii) IMP, UMP and gMP must test positive for sodium phosphate; and
 (iii) IMP, UMP, AMP, CMP and gMP must test positive for organic phosphate;
 (c) assay (HPLC)—optimum of not less than 96% (corrected for moisture content);
 (d) IMP and gMP have a pH of a 1 in 20 solution: between 7.0 and 8.5;
 (e) clarity and colour of solution:
 (i) 500 mg/10 mL H2O for IMP: is colourless and shows only a trace of turbidity; and
 (ii) 100 mg/10 mL H2O for gMP: is colourless and shows only a trace of turbidity;
 (f) moisture:
 (i) for inosine-5′-monophosphate disodium salt—not more than 28.5%: Karl Fischer; and
 (ii) for uridine-5′-monophosphate disodium salt—not more than 26.0%: Karl Fischer; and
 (iii) guanosine-5′-monophosphate disodium salt (gMP)—loss in drying of not more than 25% (4 hrs @ 120ºC); and
 (iv) for cytidine-5′-monophosphate (CMP)—loss in drying of not more than 6.0% (4 hrs @ 120ºC); and
 (v) adenosine-5′-monophosphate—loss in drying of not more than 6.0% (4 hrs @ 120ºC);
 (g) impurities—all nucleotides:
 (i) for IMP, gMP—amino acids: negative; and
 (ii) for IMP, gMP—ammonium salts: negative; and
 (iii) for IMP, UMP, AMP, CMP, gMP—arsenic: not more than 2 ppm; and
 (iv) for IMP, UMP, AMP, CMP, gMP—heavy metals: not more than 10