New Zealand Gazette – 2015 – No. 50

Page 13

✨ Specifications for nucleotides and oils



NEW ZEALAND GAZETTE, No. 50 — 8 MAY 2015

(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 @ 120°C); and

(iv) for cytidine-5′-monophosphate (CMP)—loss in drying of not more than 6.0% (4 hrs @ 120°C); and

(v) adenosine-5′-monophosphate—loss in drying of not more than 6.0% (4 hrs @ 120°C);

(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 ppm;

(h) related foreign substances:

(i) for IMP—only 5′-inosinic acid is detected by thin layer chromatography; and

(ii) for gMP—only 5′-guanylic acid is detected by thin layer chromatography;

(i) bacteriological profile:

(i) *SPC—not more than 1 000/g, test per current FDA/BAM procedures; and

(ii) coliforms—negative by test; test per current FDA/BAM procedures; and

(iii) yeast and mould—not more than 300/g, test per current FDA/BAM procedures; and

(iv) salmonella—negative, test per current FDA/BAM procedures.

S3–19 Specification for oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)

For oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA), the specifications are the following:

(a) full chemical name for DHA—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3);

(b) DHA (%)—minimum 35;

(c) trans fatty acids (%)—maximum 2.0;

(d) lead (mg/kg)—maximum 0.1;

(e) arsenic (mg/kg)—maximum 0.1;

(f) mercury (mg/kg)—maximum 0.1;

(g) hexane (mg/kg)—maximum 0.3.

S3–20 Specification for oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA)

For oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA), the specifications are the following:

(a) full chemical name for ARA—5,8,11,14-eicosatetraenoic acid (20:4n-6 ARA);

(b) ARA (%)—minimum 35;

(c) trans fatty acids (%)—maximum 2.0;

(d) lead (mg/kg)—maximum 0.1;

(e) arsenic (mg/kg)—maximum 0.1;



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Online Sources for this page:

Gazette.govt.nz — PDF NZ Gazette 2015, No 50




✨ LLM interpretation of page content

🏥 Testing requirements for nucleotides (continued from previous page)

🏥 Health & Social Welfare
Nucleotides, Testing requirements, Ultraviolet absorbance, Physical inspection

🏥 Specification for oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)

🏥 Health & Social Welfare
DHA, Algae oil, Chemical specifications, Contaminants

🏥 Specification for oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA)

🏥 Health & Social Welfare
ARA, Fungus oil, Chemical specifications, Contaminants