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Rheoliadau Bwydydd Newydd (Awdurdodiadau) a Chyflasynnau Mwg (Addasu Awdurdodiadau) (Cymru) 2022

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2.  Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (fel y’i mewnosodir gan baragraff 2 o Atodlen 4 i’r Rheoliadau hyn) mewnosoder y cofnod a ganlyn—

"6’-Sialyllactose (6’-SL) sodium salt (microbial source)

Description:

6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid

Source: 

Genetically modified strain of Escherichia coli K-12 DH1 

Definition:

Chemical formula: C23H38NO19Na

Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt

Molecular mass: 655.53 Da

CAS No 157574-76-0 

Characteristics/Composition:

Appearance: White to off-white powder or agglomerate

Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94.0 % (w/w)

6’-Sialyllactose sodium salt (% of dry matter): ≥ 90.0 % (w/w)

D-Lactose: ≤ 5.0 % (w/w)

Sialic acid: ≤ 2.0 % (w/w)

6’-Sialyl-lactulose: ≤ 3.0 % (w/w)

Sum of other carbohydrates: ≤ 3.0 % (w/w)

Moisture: ≤ 6.0 % (w/w)

Sodium: 2.5-4.5 % (w/w)

Chloride: ≤ 1.0 % (w/w)

pH (20 °C, 5 % solution): 4.5-6.0 

Residual protein: ≤ 0.01 % (w/w) 

Microbiological criteria:

Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g 

Salmonella sp.: Absence in 25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units."

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