Pharmaceutical Raw Materials

CertiPro Series
Ver.4

Pharmaceutical Raw Materials [CertiPro Series]
FUJIFILM Wako Pure Chemical provides pharmaceutical raw materials that are used in the manufacturing
process of pharmaceutical products. Ingredients listed in official compendia such as the JapanesePharmacopoeia(JP), Japanese Pharmaceutical Codex (JPC), and Japanese Pharmaceutical Excipients (JPE)
are available, and, in addition, non-compendial ingredients (not listed in official compendia) are provided inaccordance with our own specifications. These products are classified into two categories depending on
compliant standards: CertiPro (GMP-compliant products) and CertiPro-L (ISO9001-compliant products).
Some products conform the specifications items in the USP-NF and Ph. Eur. and undergo endotoxins test.

GMP-compliant Products

ISO9001-compliant Products

CertiPro

CertiPro-L

Pharmaceutical raw materials manufactured under GMP.
The lineup includes products listed in the JapanesePharmacopoeia (JP), Japanese Pharmaceutical Codex(JPC), and Japanese Pharmaceutical Excipients (JPE).

Pharmaceutical raw materials manufactured under ISO
9001. The lineup includes products conforming to theJapanese Pharmacopoeia (JP) and JapanesePharmaceutical Excipients (JPE). Non-compendial
products not listed in official compendia are provided inaccordance with our own specifications.

Features
・GMP compliant
・Products listed in the JP, JPC, and JPE・Conforming to the speciﬁcations in the USP-NF and Ph.
Eur. (depending on the product)

Features・ISO9001 compliant・Lineup including products listed in the JP and JPE, andnon-compendial productsManagement system of CertiPro Series■ Production Management of CertiPro

Documentation
andrecords

Production
manualStability
monitoring

Quality risk
management

Management of
suppliers

Sanitation
andmaintenance

GMP
compliant
Validation
Deviation
control

Process validation
Cleaning validation
Facility validation

Changecontrol

CertiPro

CertiPro-L

GMP

ISO 9001

CoA available●●

Statement available●●

Supplier management●●＊

Change control●●＊

Deviation control●●＊

Process control validation●

Quality management＊Management using ISO quality management system

01

Production Sites
Aichi Plant

GMP・Large-scale manufacturing plant
for raw mate r ia ls, inte r me diate s
and chemicals
・Advanced pollution control
・GMP-controlled media production

Harima Plant
・Backup plant of Aichi plant・Medium-scale chemical
manufacturing plantMiyazaki Plant

GMP

・Small-scale manufacturing
plant for raw materials, intermediates and chemicals

Hirono Plant

GMP・Manufacture of APIs with cGMP
・Equipped with a super lowtemperature reactor, a hydrogenation
reduction reactor, a fluoride
resistant oven and various mills.

Tokyo Plant
・non-GMP pharmaceutical intermediate manufacturing
・R&D laboratory

Hiratsuka Plant
・non-GMP pharmaceutical intermediate manufacturing
・Multipurpose facilities

Osaka Plant

GMP

・GMP-compliant pharmaceutical manufacturing
・Licensed pharmaceutical manufacturer■ Main Products

・Pharmaceutical raw materials
・Life science reagents (PCR detection reagent, DNA extraction
kit etc.)
・Chemical reagent (powder・liquid reagents)
・Process solution
・Clinical diagnostic reagent■ Inspection and Audit History

Location
Site area
Number of employees
Start of operation
Certifications

Amagasaki City, Hyogo Prefecture
23,332㎡
About 220
Since 1940
ISO9001，ISO/IEC17025
ISO14001，ISO17034

Japanese authorities
・2017.10 GMP conformity survey by Hyogo Prefectural
Pharmaceutical Affairs Division (Regular/Export)
・2018.10 GMP conformity survey by Hyogo Prefectural Pharmaceutical Affairs Division (Partial change)
・2021.10 GMP conformity survey by Hyogo Prefectural Pharmaceutical Affairs Division(Regular/Export)
Conduct 5-10 on-site quality audits each year from Japanese and overseas clients※All GMP facilities except Aichi plant are audited by Japanese Authority

02

Statement
FUJIFILM Wako Pure Chemical issue our Statement on Raw Materials for Pharmaceutical Use to provide
information about our products as well as information on the drug risk management. Here are some ofthe details included in the statement. Statements are obtainable from product introduction page on our
website.

BSE/
TSE

Elemental
impurities

Residual
solvents
Nitrosamines
Allergenic
substancesCountryof origin

Product Profile：Chemical name, CAS RN ®, Product code, Manufacturing control standard, Grade
Product Information：Country of origin, BSE/TSE, GMO, Allergenic substances
Highly potency substance, Nitrosamines, Melamine

Customized Service
FUJIFILM Wako Pure Chemical offer custom services to meet customer requirements. We respond to a varietyof requests, including large-scale packaging for scale-up, and compliance with the standards of various
compendial standards, including the JP, USP-NF and Ph. Eur. Please contact us for details.

Customize package

Compendial
JP, USP-NF, Ph. Eur.

＊For more information, please visit website.
Top of our Raw material Pharmaceutical Industry website
https://labchem-wako.fujifilm.com/us/pharmaceutical-raw-materials/index.html

03Additional test
Endotoxin test etc.

Preparesolution

Packaging
The basic packaging of CertiPro series are 500g, 10kg and 20kg. Depending on your request, FUJIFILM
Wako can change the pacakge size and specifications.

Package Size

Basic Packaging

Customized Packaging

〜

50kg

25kg

〜

25kg

5kg

500g/
500mL

*For requests for package size and speciﬁcations other thanthose listed above, please contact us.

Basic Packaging (5kg~25kg)
Inner packaging●Double or triple polyethylene bags
●Designed for use in clean rooms, etc.,
the product can be removed in stages.
(Label attached to the second layer ofpolyethylene bag from the outside)

Outer packaging●Cardboard (H-lined)②①②

Details of H-lined
Paste one piece of ① andthen paste it in the gap of ②

04

CertiPro■ Features● GMP compliant● Issuing a Statement＊1● Conforming to the specifications in the USP-NF and Ph. Eur.＊2 (depending on the product)＊1 Statement containing quality information such as product information (origin, BSE/TSE, GMO, etc.), impurity data (residual
solvents, elemental impurities), etc. can be obtained from website.
＊2 Specification of products reflects latest versions of pharmacopeia.

■ Product Lineup
Please contact us for individual requests regarding capacity.
Product
Code

NEW

Conformity
Product Name

Grade

PackageSize

CAS RN®

Chemical
FormulaPrincipal
Use

Less than
10EU/g

10kg

616-91-1

C5H9NO3S

Culture medium
additive

500 g10035-04-8

CaCl2・2H2O

Stabilizer

299-28-5

C12H22CaO14
・H2O

Calcium
additive5949-29-1

C6H8O7
・H2O

Stabilizer・
Buffer7758-11-4

K2HPO4

Buffer

USP- Ph. Endotoxin
NF Eur.

013-28757

Acetylcysteine

JP030-19555

Calcium Chloride Hydrate

JP

Less than
2.5EU/g

Calcium Gluconate
HydrateJP

Less than
1.5EU/gCitric Acid Hydrate

JP

Dibasic Potassium
Phosphate

JPC

Dibasic Sodium Phosphate
HydrateJP

Disodium Edetate HydrateJP037-26035
033-26037
032-25245
047-29015
043-29017
047-34385
043-34387

P

P

P

P

20kg

P

P

Less than
0.2EU/gLess than
10EU/g049-34345

Less than
10EU/gJP045-34347
076-05705

0510039-32-4
10 kg
500 g

Na2HPO4
・12H2O

Buffer6381-92-6

C10H14N2Na2O8・2H2O

Stabilizer

497-19-8

Na2CO3

Buffer50-99-7

C6H12O6

Stabilizer

20 kg
500 g
10 kg

ー

JP

072-05707

10 kg

075-06875

GlycineJP082-10475

Hydrochloric AcidJP

121-06685

Lactose HydrateJP130-18925

Magnesium Sulfate
HydrateJP133-14495

D-Mannitol

JP

Monobasic Potassium
Phosphate

JPC

132-14487

500g

500 g
Glucose136-14485

500 g
500 g

042-34617

NEW

10 kg

ー

046-34615

Dried Sodium Carbonate

Less than
8EU/g

500 g

P

＊3

＊3

P

Less than
1.2EU/g

500 g

56-40-6

C2H5NO2

StabilizerP

Less than
500 mL
10EU/g7647-01-0

HCl

Stabilizer・
BufferLess than
25EU/g

500 g64044-51-5

C12H22O11
・H2O

Excipient

Less than
10EU/g500 g10034-99-8

Less than
2.5EU/g

500 g

69-65-8

C6H14O6

Stabilizer

7778-77-0

KH2PO4

BufferMgSO41・7H2O

Stabilizer

500 g
ー
25 kg

Conformity

Product
Code

Product Name

163-22105

Potassium ChlorideJP

161-21925

Potassium Iodide

JP

Purified Glucose

JP

Grade

168-28515

Sodium Acetate Hydrate

JP

Sodium BicarbonateJPP

193-18477
194-18505
JPP

P

190-18507
197-18855
Sodium Citrate Hydrate

JP

P

P

193-18857
191-18495
197-18497
135-15555
131-15557

Sodium Dihydrogen
Phosphate Dihydrate

JPE

Sodium L-Glutamate
HydrateJPC

Sodium Hydroxide

JP

P

P

(NF) -＊4

190-18465(NF)P

196-18467
196-19165
192-19167

Sodium Thiosulfate
HydrateJP

Sucrose

JP

(NF)

P

194-18387

NEW

193-19197

Sucrose[Low endotoxin type(Less than 0.2EU/g)]

JP

Trometamol

JPC

(NF)

P

203-21035
209-21037

213-01295

Urea

JP

Principal
Use

ー

500 g

7447-40-7

KCl

Bufferー

500 g

7681-11-0

KIStabilizer・
Soluble agent

50-99-7

C6H12O6

Stabilizer

6131-90-4

C2H3NaO2
・3H2O

Buffer144-55-8

NaHCO3

Buffer

7647-14-5

NaCI

Stabilizer・
Buffer6132-4-3

C6H5Na3O7
・2H2O

Stabilizer・
Buffer13472-35-0

NaH2PO4・2H2O

Buffer6106-4-3

C5H8NNaO4
・H2O

Stabilizer・
Buffer1310-73-2

NaOH

Buffer10102-17-7

Na2S2O3・5H2O

Stabilizer・
Solubleagent

57-50-1

C12H22O11

Stabilizer

57-50-1

C12H22O11

Stabilizer

77-86-1

C4H11NO3

Buffer

57-13-6

CH4N2O

Stabilizer

Less than
10EU/gLess than
3.1EU/gLess than
5.2EU/gLess than
2.0EU/gLess than
3.9EU/gLess than
10EU/gLess than
10EU/g198-18385

197-19195

Chemical
Formulaー197-18475

Sodium Chloride

CAS RN®

Less than
2EU/g

＊3

164-28517
197-13235

Package
Size

USP- Ph. Endotoxin
NF Eur.

P

P

Less than
2EU/g

Less than
0.2EU/gLess than
0.03IU/g

Less than
2.5EU/g

500 g
10 kg
500 g
500 g
10 kg
500 g
10 kg
500 g
10 kg
500 g
10kg
500 g
20 kg
500 g
10 kg
500 g
20 kg
500 g
10 kg
500 g
10 kg
500 g
10 kg
500 g
10 kg

＊3 These products are tested according to JP method. Some of the test items are harmonized to USP-NF Ph.Eur. For details, please checkthe product specifications.
＊4 This product is not listed in Ph.Eur.

■For more information, please visit website.
Top of our Raw material Pharmaceutical Industry website ＞GMP compliant Products CertiPro
https://labchem-wako.fujifilm.com/us/pharmaceutical-raw-materials/product/certipro.html

06

CertiPro-L■ Features● Lineup including products listed in the JP and JPE● Non-compendial products not listed in official compendia are provided in accordance with our own

specifications.
● ISO9001 compliant● Issuing a Statement＊1＊1 Statement containing quality information such as product information (origin, BSE/TSE, GMO, etc.), impurity data (residual
solvents, elemental impurities), etc. can be obtained from website.

■ Product Lineup
Please contact us for individual requests regarding capacity.
Product
Code

Conformity
Product Name

CAS RN®

Grade USP-

Ph. Endotoxin
Eur.

NF

Package
Size

Chemical
FormulaPrincipal
Use

500 g

C4H11NO3

10 kg

・HCl

500 g

C6H6O9P·3/2Mg·nH2O

Culturemediumadditive

Na2HPO4

BufferC 4H 4O 4

Buffer012-28445 2-Amino-2-hydroxymethyl1,3-propanediol
018-28447 Hydrochloride

1185-53-1―

Max.
10EU/g

L-Ascorbic Acid Phosphate
NEW 018-28545 Magnesium Salt n -Hydrate

171326525-8―

Less than
10EU/g7558-79-4

JPE

Less than
2.5EU/g

110-17-8

JPE

-＊

―

075-05155 Glucono-δ-Lactone

90-80-2

JPE-＊

Less than
2.0EU/g

500 g

C6H10O6

Buffer136-15105 Magnesium Stearate557-04-0

JP

―

500 g

C36H70MgO4

LubricantNEW 132-19421 Methyl Parahydroxybenzoate

99-76-3

JP

―

5 kg

C 8H 8O 3

Preservative

168-22792 Polysorbate20

9005-64-5

JPE

―

25 g

ー

Stabilizer

169-21965 Potassium Acetate

127-08-2

JPE

―

500 g

CH3COOK

BufferNEW 169-29221 Propyl Parahydroxybenzoate

94-13-3

JP

―

5 kg

C10H12O3

Preservative

Sodium Bisulfite

7631-90-5

JP

NaHSO3

Stabilizer・
BufferSodium Dextran Sulfate 5000

9011-18-1―

ー

Culturemediumadditive

Sodium Dihydrogen
190-14107 Phosphate Anhydrous

7558-80-7

JPE-＊

Less than
2.0EU/g

500 g

NaH2PO4

Buffer197-13975 Sodium L-Tartrate

6106-24-7

JPE

-＊

―

500 g

C4H4Na2O6・2H2O

BufferSodium Pyrosulfite

7681-57-4

JP―

Na2S2O5

Preservative

Titanium Oxide

13463-67-7

JP

―

TiO2

Excipient048-29665

Disodium Hydrogen044-29667 Phosphate Anhydrous
068-05105
064-05107

198-13265
194-13267
196-19182
190-19185

Fumaric Acid

194-14105

193-14055
199-14057
204-16055
903-40303

2

2

＊3
(NF)

P

(NF)

P

-＊

―

2

Less than
50EU/g
2

2

500 g
10 kg
500 g
20 kg

500 g
20 kg
25 g
500 g

10 kg

500 g
10 kg
500 g
10 kg

Buffer＊2 These products are not listed in USP-NF and Ph.Eur.
＊3 These products are tested according to JP method. Some of the test items are harmonized to USP-NF Ph.Eur. For details, please checkthe product specifications.
■For more information, please visit website.
Top of our Raw material Pharmaceutical Industry website ＞ISO 9001 compliant Products CertiPro-L
https://labchem-wako.fujifilm.com/us/pharmaceutical-raw-materials/product/certiprol.html

07Semi-custom made liquid for biopharmaceutical
FUJIFILM Wako Pure Chemical offer a lineup of prepared process solutions that can be used inbiopharmaceutical manufacturing processes. You can choose your desired concentration, package
size, and format.
Product Name

Concentration

Product appearance image

Package Size

0.5mol/L

Sodium hydroxide
solution

1mol/L
5mol/L

Ethanol aqueous
solution

20%

Acetic acid solution

40%

Hydrochloric acidsolution

1mol/L50%

10L：Plastic bottle
200L：Plastic drum
Upon request, we canalso fill single-use bags
that are ready to use.

0.1mol/L
0.5mol/L

Sodium chloride
solution

1mol/L
2mol/L
0.5mol/L

Phosphoric acidsolution

1mol/L
2mol/L

Customized liquid preparation service
FUJIFILM Wako Pure Chemical provide process solutions tailored to customer requests. You can freely
design the management system, raw materials used, test items, package size and format, etc. according
to your application.
1

Management
system

ISO9001
GMP

2

Main rawmaterials

Water for preparation

3

Test items

Concentration

4

Packaging5

Customized
products

Basic packaging

Puriﬁed water (JP)Appearance

BottleWFI Quality Water

pH

Polyethylene bags

Pyrogen free water

Each pharmacopeia
monograph test

Cardboard (Outer packaging)Raw materials used

Osmotic pressure

Reagent

Sterility test

Pharmacopeia testcompliant product

Endotoxin

Media excipient
Pharmaceutical
Raw Materials

Mycoplasma

Plastic drum (Outer packaging)
Fiber drum (Outer packaging)）
Single use bag
2D bag
3D bagLarge package size
Container
Tank
Link container

08

Product examples by manufacturing process■ Manufacturing process of antibody drugs
Upstream

Small scale culture

Expansion culture

Production culture

Antibodies containing
impurities

Downstream
Virus
inactivation

Buffer controlVirusremoval

Chromatography

Antibody
drug substance

Upstream
Product Code

Product Name

Conformity

Package Size

CAS RN®

Amino acid075-06875
135-15555
131-15557

GlycineJP, USP, Ph.Eur.

Sodium L-Glutamate Hydrate

JPC,NF

Dried Sodium Carbonate

JP

Sodium Bicarbonate

JP, Ph.Eur.

Fumaric Acid

JPE

Sodium Dextran Sulfate 5000

ー

500g
500g
20kg

56-40-6
6106-04-3

Buffer049-34345
045-34347
197-18475
193-18477

500g
10kg
500g
10kg

497-19-8

144-55-8

Other
068-05105
064-05107
196-19182
190-19185

09

500g
20kg
25g
500g

110-17-8

9011-18-1

Downstream
Product Code

Product Name

Conformity

Package Size

CAS RN®

Tris
012-28445
018-28447
203-21035
209-21037

2-Amino-2-hydroxymethyl-1,3propanediol Hydrochlorideー

Trometamol

JPC, USP, Ph.Eur.

500g
10kg
500g
10kg

1185-53-1

77-86-1

Phosphate buffer048-29665
044-29667
047-29015

Disodium Hydrogen Phosphate Anhydrous JPE

500g
10kg
500g

7558-79-4

Dibasic Potassium Phosphate

JPC, USP, Ph.Eur.

Dibasic Sodium Phosphate Hydrate

JP, USP, Ph.Eur.

Monobasic Potassium Phosphate

JPC, NF, Ph.Eur.

Sodium Dihydrogen Phosphate Anhydrous

JPE

Sodium Dihydrogen Phosphate Dihydrate

JPE, USP, Ph.Eur.

Sodium Acetate Hydrate

JP

500g

6131-90-4

Citric Acid Hydrate

JP, USP, Ph.Eur.

500g

5949-29-1

Sodium Citrate Hydrate

JP, USP, Ph.Eur.

Dried Sodium Carbonate

JP

Sodium Bicarbonate

JP, Ph.Eur.

Hydrochloric Acid

JP, Ph.Eur.

Sodium Hydroxide

JP, NF, Ph.Eur.

030-19555

Calcium Chloride Hydrate

JP

500g

10035-04-8

163-22105

Potassium Chloride

JP

500g

7447-40-7

Sodium Chloride

JP, USP, Ph.Eur.

Polysorbate20

JPE

043-29017
047-34385
043-34387
136-14485
132-14487
194-14105
190-14107
191-18495
197-18497

20kg
500g
10kg
500g
25kg
500g
10kg
500g
10kg

7758-11-4

10039-32-4

7778-77-0

7558-80-7

13472-35-0

Acetate buffer
197-13235
Citrate buffer032-25245
197-18855
193-18857

500g
10kg

6132-04-3

Carbonate049-34345
045-34347
197-18475
193-18477

500g
10kg
500g
10kg

497-19-8

144-55-8

Acid/Base082-10475
190-18465
196-18467

500mL
500g
10kg

7647-01-0
1310-73-2

Salts

194-18505
190-18507

500g
10kg

7647-14-5

Surfactant
168-22792

25g

9005-64-5

10

FUJIFILM Wako Pure Chemical Corporation
https://labchem-wako.fujifilm.com/us/pharmaceutical-raw-materials/index.html
1-2 Doshomachi 3-Chome, Chuo-Ku, Osaka 540-8605, Japan
Tel : +81 6 6203 3741 Fax : +81 6 6203 1999
ffwk-cservice@fujiﬁlm.com

FUJIFILM Wako Chemicals U.S.A. Corporation

FUJIFILM Wako Chemicals Europe GmbH

1600 Bellwood Road, Richmond, VA 23237, U.S.A
Toll-Free(U.S.only):+1 877 714 1920
Tel: +1 804 271 7677 Fax: +1 804 271 7791
wkuslabchem@fujiﬁlm.com

Fuggerstr 12,41468 Neuss, Germany
Tel: +49 2131 311 0 Fax: +49 2131 311 100
labchem̲wkeu@fujiﬁlm.com

FUJIFILM Wako Chemicals (Hong Kong) Limited

FUJIFILM Wako (Guangzhou)Trading Corporation

Room 1111,11/F,International Trade Centre,11-19 Sha Tsui Road,
Tsuen Wan, N,T.,Hong Kong
Tel: +852-2799-9019 Fax: +852-2799-9808
wkhk.info@fujiﬁlm.com

Room 3003,30/F.,Dong Shan Plaza 69, Xian Lie Zhong Road,
Guangzhou, 510095, China
Tel: +86-20-8732-6381(Guangzhou)
Tel: +86-21-6288-4751(Shingahal)
Tel: +86-10-6413-6388(Beijing)whgz.info@fujiﬁlm.com

24600開11P