Apb 2021-12-14

Certifícate of Anaiysis
Certifícate of A n a i y s i s I D : 1072280500_VI4969328_EN
Producer and client: Merclí KGaA, Frankfurter Str. 2 5 0 , 6 4 2 9 3 Darmstadt, G e r m a n y

. .-i
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Merck KGaA Qualitátskontrolle für mikrobiologische Produkte

Frankfurter Str. 2 5 0 , 6 4 2 9 3 Darmstadt, G e r m a n y
T e s t laboratory:
GranuCult® Buffered Peptone W a t e r
Sample identifícatíon: acc. I S O 6579, I S O 19250, I S O 21528, I S O 22964, I S O 6887,

FDA-BAM und EP
Ordering number: 1.07228.0500
Lot number: VM969328
Accreditation: The test laboratory of Merck KGaA is accredited by

the Germán accreditation authority DAkkS as
registered test laboratory D-PL-15185-01-00 (( DAkkS
according to DIN ISO/IEC 17025 for the SlL.ng>«,«e
performance testing of media for microbiology &PLI5ISSOIOO
according to DIN EN ISO 11133:2014.
T e s t method: Performance testing of liquid culture media:

Qualitative single tube method (turbidity) for performance testing of
liquid media)
Performance testing of diluents; Quantítative method ^„
Date of a n a i y s i s : 2021/03/25
Date of reléase: 2021/03/31
Mínimum shelf life: 2026/03/17 V /
Composition ( g / l ) : Peptone (includes enzymatic digest of casein) 10.0; Sodium chioride

5.0; Potassium dihydrogen phosphate 1.5; di-Sodium hydrogen
phosphate dodecahydrate 9.0.
Preparation & sterilization: Dissolve 25.5 g in 1 1 of purified water. If desired dispense Into smaller
vesseis and autoclave 15 min at 121 °C.
Application: For the preliminary non-selective enrichment of bacteria, particularly

pathogenic Enterobacteriaceae such as Salmonella and Cronobacter,
and for the initial suspensión and dilution of samples from food and
animal feed, water and other materials.
Storage: Store at +15 °C to +25 °C, dry and tightiy closed. Do not use clumped
or discolored médium. Protect from UV light (including sun light).
The reported results refer exclusively to the specified médium, see Certifícate of Anaiysis ID.
Merck K G a A • Frankfurter StraBe 2 5 0 , 6 4 2 9 3 Darmstadt, G e r m a n y : + 4 9 6 1 5 1 7 2 - 2 4 4 0

E M D Millipore C o r p . • 2 9 0 C o n c o r d R o a d , B i l l e r i c a , MA 0 1 8 2 1 , U S A + 1 - 9 7 8 - 7 1 5 - 4 3 2 1 1072280500_VM969328_EN
A T C C is a r e g i s t e r e d t r a d e m a r k o f A T C C , M a n a s s a s , V A , U S A . L i t . N o . T N 1 0 5 4 0 6 E N O O P a g e 1/3
Certifícate o f A n a i y s i s
Physícal p a r a m e t e r s Specification Lot valué

Appearance (clarity): clear clear
Appearance (color): yeilowish yeilowish
pH-value (25 °C): 6.8 - 7.2 7.0
Microbiologicai P e r f o r m a n c e
Qualitative single tube method (turbidity) for performance te s ting of liquid media
Specification Lot valué

Test strain
InoGulum Growth Inoculum Growth
Escherichia col!
good to good to
ATCC® 25922 < 100 CFU 89 CFU
very good very good
[WDCM 00013]
Escherichia col!
good to good to
ATCC® 8739 S 100 CFU 30 CFU
very good very good
[WDCM 00012]
Salmonella typhimurlum
good to good to
ATCC® 14028 < 100 CFU 88 CFU
very good very good
[WDCM 00031]
Salmonella enteritidis
good to good to
ATCC® 13076 < 100 CFU 73 CFU
very good very good
[WDCM 00030]
Salmonella abony good to good to
á 100 CFU 63 CFU
NCTC 5017 very good very good
Cronobacter sakazakii
good to good to
ATCC 29544 < 100 CFU 25 CFU
very good very good
[WDCM 00214]
Cronobacter muytjensii
good to good to
ATCC 51329 < 100 CFU 44 CFU
very good very good
[WDCM 00213]
Incubation: 18 ± 2 hours at 37 ± 1 °C aerobic

Salmonella abony 18 - 24 hours at 30 - 35 °C aerobic
Cronobacter 18 ± 2 hours at 34 - 38 °C aerobic
Merck KGaA • Frankfurter StraSt 250, 64193 Darmstadt, Germany: + 4 9 6 1 5 1 7 2 - 2 4 4 0

Í M D Millipore Corp. > 190 Concord totd, Üllerica, MA 0 1 8 2 1 , USA + 1 - 9 7 8 - 7 1 5 - 4 3 2 1 1072280500„VM969328_EN
ATCC i i a r t i i s t t r i d tradf mark of ATCC, Manassas, VA, USA, L i t . N o . T N 1 0 5 4 0 6 E N O O Page 2/3
Certifícate of Anaiysis
Performance testing of diluents: Quantítative method

\
Lot valué
Test strain j Specification
to on TSA ti on TSA
Recovery rate
CFU CFU
Stapliylococcus aureus
ATCC® 25923 70 - 130 % 89 69 78 %
[WDCM 00034]
Esciierichia coli-
ATCC® 25922 70 - 130 % 29 21 72 %
[WDCM 00013]
Escherichia coli
ATCC® 8739 70 - 130 % 14 16 114 %
[WDCM 00012]
Incubation: 45 minutes up to 1 hour at 18 - 27 °C (laboratory ambient

temperature)
Reference médium ( i n o c u l u m ) : Tryptic Soy Agar
All t e s t methods listed a r e according to D I N EN I S O 1 1 1 3 3 : 2 0 1 4 .
Signature:
Dr. Stefanie FIscher

Head of Quality Control Microbiology
StraSe 250, 6 4 2 9 3 D a r m s t a d t , G e r m a n y : + 4 9 6 1 5 1 7 2 - 2 4 4 0
M e r c k K G a A • ^i^j^s^^mr
1072280500_VM969328_EN
8«(DcNMÍp%% Cftffi. •. MQ Concord R o a d , B i l l e r i c a , M A 0 1 8 2 1 , U S A + 1 - 9 7 8 - 7 1 5 - 4 3 2 1
m^0'éPflkí^¿&q ffademark o f A T C C , M a n a s s a s , V A , U S A . L i t . N o . T N 1 O 5 4 0 6 E N 0 0 Page 3/3
A T C C is a r e i r a - n ^

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Certifícate of Anaiysis

Producer and client: Merclí KGaA, Frankfurter Str. 2 5 0 , 6 4 2 9 3 Darmstadt, G e r m a n y

Merck KGaA Qualitátskontrolle für mikrobiologische Produkte

Sample identifícatíon: acc. I S O 6579, I S O 19250, I S O 21528, I S O 22964, I S O 6887,

Ordering number: 1.07228.0500

Lot number: VM969328

Accreditation: The test laboratory of Merck KGaA is accredited by

according to DIN EN ISO 11133:2014.

T e s t method: Performance testing of liquid culture media:

Performance testing of diluents; Quantítative method ^„

Date of reléase: 2021/03/31

Mínimum shelf life: 2026/03/17 V /

Composition ( g / l ) : Peptone (includes enzymatic digest of casein) 10.0; Sodium chioride

Application: For the preliminary non-selective enrichment of bacteria, particularly

Merck K G a A • Frankfurter StraBe 2 5 0 , 6 4 2 9 3 Darmstadt, G e r m a n y : + 4 9 6 1 5 1 7 2 - 2 4 4 0

Physícal p a r a m e t e r s Specification Lot valué

Specification Lot valué

Incubation: 18 ± 2 hours at 37 ± 1 °C aerobic

Merck KGaA • Frankfurter StraSt 250, 64193 Darmstadt, Germany: + 4 9 6 1 5 1 7 2 - 2 4 4 0

Performance testing of diluents: Quantítative method

Incubation: 45 minutes up to 1 hour at 18 - 27 °C (laboratory ambient

Reference médium ( i n o c u l u m ) : Tryptic Soy Agar

All t e s t methods listed a r e according to D I N EN I S O 1 1 1 3 3 : 2 0 1 4 .

Dr. Stefanie FIscher

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