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Liofilchem®
Certificate of Analysis
Page 1 of 1
Product
Batch
Expiration date
MUELLER HINTON II AGAR
081414002
2015.02.10
Ref. 10031 – 10031* – 10231 – 12031
Physical quality control
Specification
Results
Expected pH-value (25°C)
7.3 ± 0.2
Appearance of medium
Slightly opalescent
Conforms
Colour of medium
Amber
Conforms
7.4
Microbiological State
Sampled according to ISO 2859-1, Special Inspection Level: S-2
Incubation
Specification
35 ± 2°C (after 7 days)
No growth
Conforms
No growth
Conforms
22 ± 2°C (after 7 days)
All units of this batch were checked before packaging.
Results
Microbiological Performance
Tested according to CLSI M22-A3, CLSI M6-A2, ISO 11133-1 and ISO 11133-2
Antimicrobial Susceptibility Testing, Method of control: Disc Diffusion
Inhibition halo ranges as recommended by CLSI M100-S24 and CLSI M6-A2
Inoculum: McFarland 0.5
Control strains
Staphylococcus
aureus
ATCC® 25923
Escherichia coli
ATCC® 25922
Pseudomonas
aeruginosa
ATCC® 27853
Enterococcus faecalis
ATCC® 29212
Incubation
Antimicrobial agent
Expected results
Halo range (mm)
Results
Aerobic, 16-18 h, 35 ± 2°C
Amoxicillin + Clavulanic acid AUG 30 (20+10) µg
28-36
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Ampicillin + Sulbactam AMS 20 (10+10) µg
29-37
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Tetracycline TE 30 µg
24-30
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Amoxicillin + Clavulanic acid AUG 30 (20+10) µg
18-24
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Ampicillin AMP 10 µg
16-22
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Gentamicin CN 10 µg
19-26
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Tetracycline TE 30 µg
18-25
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Trimethoprim + Sulfamethoxazole SXT 25
(1.25+23.75) µg
23-29
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Ceftazidime CAZ 30 µg
22-29
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Gentamicin CN 10 µg
16-21
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Ticarcillin + Clavulanic acid TTC 85 (75+10) µg
20-28
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Tobramycin TOB 10 µg
20-26
Conforms
Aerobic, 16-18 h, 35 ± 2°C
Trimethoprim + Sulfamethoxazole SXT 25
(1.25+23.75) µg
≥ 20
Conforms
Batch Release
Approved
Date
21.08.2014
Signature
Quality Control
(D. Vitagliano)
The results reported were obtained at the time of release.
Liofilchem® s.r.l. Via Scozia - Zona Industriale 64026, Roseto degli Abruzzi (TE) Italy - Tel +39 0858930745 - Fax +39 0858930330
CoA Ref. 10031 – 10031* – 10231 – 12031 Rev. 9 of 31.01.2014