✨ Nucleotide Testing Requirements
4552 NEW ZEALAND GAZETTE No. 170
b) IMP, UMP and GMP must test positive for sodium phosphate
c) IMP, UMP, AMP, CMP and GMP must test positive for organic phosphate
- Assay (HPLC):
Optimum - not less than 96% (corrected for moisture content).
-
IMP and GMP have a pH of a 1 in 20 solution: between 7.0 and 8.5
-
Clarity and colour of solution:
500mg/10mL H₂O for IMP: is colourless and shows only a trace of turbidity
100mg/10mL H₂O for GMP: is colourless and shows only a trace of turbidity
- Moisture
| Nucleotide | Moisture |
|---|---|
| Inosine - 5' monophosphate disodium salt | Not more than 28.5%: Karl Fischer |
| Uridine - 5' monophosphate disodium salt | Not more than 26.0%: Karl Fischer |
| Guanosine - 5' monophosphate disodium salt | Loss in drying |
| - not more than 25% | |
| (4 hrs @ 120°C) | |
| Cytidine - 5' monophosphate | Not more than 6.0%: Loss in drying (4 hrs @ 120°C) |
| Adenosine- 5' monophosphate | Not more than 6.0%: Loss in drying (4 hrs @ 120°C) |
- Impurities - all nucleotides
| Impurity | Nucleotide |
|---|---|
| Amino acids: negative | IMP, GMP |
| Ammonium salts: negative | IMP, GMP |
| Arsenic: not more than 2ppm | IMP, UMP, AMP, CMP, GMP |
| Heavy metals: not more than 10ppm | IMP, UMP, AMP, CMP, GMP |
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Online Sources for this page:
VUW Te Waharoa —
NZ Gazette 2000, No 170
Gazette.govt.nz —
NZ Gazette 2000, No 170
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Testing Requirements for Nucleotides
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🏥 Health & Social WelfareNucleotides, Testing, Sodium phosphate, Organic phosphate, HPLC, pH, Clarity, Colour, Moisture, Impurities