Download Załącznik 1. Arkusz zgodności ze specyfikacją

Załącznik 1. Arkusz zgodności ze specyfikacją - do zapytania ofertowego nr 12 10 2016 A
W poniższej tabeli należy uzupełnić trzecią kolumnę - proszę z listy wybrać TAK lub NIE. W czwartej
kolumnie można wprowadzić uwagi jeśli produkt odbiega od, określonej w drugiej kolumnie
specyfikacji.
Nazwa
L.p.
Components
L-Cystine
1.
Czy
oferowany
produkt
spełnia
wymagania
(TAK/NIE)
DMEM High Glucose, 500ml
Conc. ±
10% [mM]
0.2
L-Histidine
0.2
Calcium Chloride (CaCl2)
1.8
Sodium Phosphate monobasic (NaH2PO4)
0.92
Osmolality 320-360 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
Glycine
2.
DMEM low glucose, 500ml
Conc. ±
10% [mM]
0.4
L-Arginine
0.4
L-Serine
0.4
Pyridoxine hydrochloride
0.02
Magnesium Sulfate (MgSO4)
0.81
Sodium Phosphate monobasic (NaH2PO4)
0.92
Sodium Pyruvate
1.0
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
L-Cystine
3.
RPMI 1640, 500ml
Conc. ±
10% [mM]
0.208
Biotin
8.2E-4
Folic Acid
0.0023
Vitamin B12
3.7E-6
i-Inositol
0.194
D-Glucose (Dextrose)
11.11
Uwagi
Glutathione (reduced)
0.0033
pH Range 7.0-7.4
Osmolality 260-310 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
MEM, 500ml
Conc. ±
10% [mM]
0.4
Components
L-Isoleucine
4.
L-Leucine
0.4
Sodium Bicarbonate (NaHCO3)
26.2
Sodium Chloride (NaCl)
117.24
Sodium Phosphate monobasic (NaH2PO4)
1.01
D-Glucose (Dextrose)
5.55
No Sodium Pyruvate
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
Glycine
5.
MEM-alpha, 500ml
Conc. ±
10% [mM]
0.666
Vitamin B12
0.001
i-Inositol
0.011
Adenosine
0.037
Cytidine
0.041
Guanosine
0.035
Lipoic Acid
9.71E-4
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
L-Histidine
6.
Ham's F12, 500ml
Conc. ±
10% [mM]
0.1
Choline chloride
0.1
Magnesium Chloride (MgCl2)
0.6
Zinc sulfate (ZnSO4)
0.003
Lipoic Acid
0.001
Putrescine
0.001
Osmolality 280-310 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
IMDM, 500ml
Conc. ±
10% [mM]
0.2
Components
L-Methionine
7.
L-Phenylalanine
0.4
Niacinamide
0.033
Sodium Selenite (Na2SeO3)
6.6E-5
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Horse Serum, heat inactivated, 500ml
Origin: New Zealand
8.
EIA tested: negative
Heat Inactivated
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
DMEM/F-12 1:1, 500ml
Conc. ±
10% [mM]
0.1
Components
L-Cysteine
9.
L-Lysine hydrochloride
0.5
Hypoxanthine
0.015
Linoleic Acid
1.5E-4
Lipoic Acid
5.1E-4
pH Range 7.0-7.4
Osmolality 290-330 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Fetal Bovine Serum, 500ml
Serum Treatment
10.
Origin: South America
EU-Approved
Virus and Mycoplasma tested
Supplied with a CoA (Certificate of Analysis)
Components
Glycine
11.
DMEM no glucose no glutamine no phenol red, 500ml
Conc. ±
10% [mM]
0.4
Choline chloride
0.029
D-Calcium pantothenate
0.0084
Calcium Chloride (CaCl2)
1.8
No Glutamine
No Phenol Red
No Glucose
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
L-Tyrosine
12.
RPMI 1640, no glucose, 500ml
Conc. ±
10% [mM]
0.11
L-Methionine
0.1
Calcium nitrate (Ca(NO3)2)
0.424
Sodium Phosphate dibasic (Na2HPO4)
5.64
Glutathione (reduced)
0.00326
No Glucose
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
PBS 1x, pH=7.4, 500ml
Conc. ±
Components
10% [mM]
Potassium Phosphate monobasic (KH2PO4)
1.06
13.
Sodium Chloride (NaCl)
155.2
Sodium Phosphate dibasic (Na2HPO4)
2.97
No Calcium, No Magnesium
pH Range 7.3-7.5
Osmolality 280-315 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
PBS 10x, pH=7.4, 500ml
Conc. ±
Components
10% [mM]
Potassium Phosphate monobasic (KH2PO4)
10.6
14.
Sodium Chloride (NaCl)
1552.0
Sodium Phosphate dibasic (Na2HPO4)
29.7
No Calcium, No Magnesium
pH Range 7.3-7.5
Osmolality 2800-3100 mOsm/kg
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
15.
Components
Potassium Chloride (KCl)
Trypsin-EDTA 0.25%, 100ml
Conc. ±
10% [mM]
5.33
Potassium Phosphate monobasic (KH2PO4)
0.44
Sodium Bicarbonate (NaHCO3)
4.2
Sodium Chloride (NaCl)
137.9
Sodium Phosphate dibasic
0.336
D-Glucose (Dextrose)
5.55
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
pH Range 7.2-8.0
Osmolality 270-320 mOsm/kg
Pennicilin-Streptomycin, 100ml
10 000 U/ml penicillin
16.
10 000 ug/ml Streptomycin
100x concentrated
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Components
Glycine
17.
MEM Non-Essential Amino Acids Solution (100x), 100ml
Conc. ±
10% [mM]
10.0
L-Alanine
10.0
L-Asparagine
10.0
L-Aspartic acid
10.0
L-Glutamic Acid
10.0
L-Proline
10.0
L-Serine
10.0
No Glutamine
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
Sodium Pyruvate 100 mM, 100ml
18.
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
100x concentrated
L-Glutamine, 200 mM, 100ml
19.
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
100x concentrated
HEPES 1M, 100ml
20.
pH Range 7.2-7.5
Manufactured at a cGMP-compliant facility
certified to the ISO 13485
D-(+)-Glucose solution, 100ml
CAS Number 50-99-7
21.
concentration: 100 g/L in H2O
sterile-filtered
suitable for cell culture