GMP Management Products

CertiPro

FUJIFILM Wako provides pharmaceutical raw materials that can be used in the manufacturing process of pharmaceutical products. CertiPro is a series of raw materials for pharmaceutical products, which is manufactured under GMP control.

Pharmaceutical Raw Materials

GMP Management Products
CertiPro

Pharmaceutical raw materials manufactured under GMP management. The lineup includes products conforming to the Japanese Pharmacopoeia, Japanese Pharmaceutical Codex (JPC), and part of the Japanese Pharmaceutical Excipients (JPE).
Features
- GMP management
- Products listed in the Japanese Pharmacopoeia and JPC, and some listed in the JPE
- Conforming to the specifications in the USP and Ph. Eur. (different depending on the product)
Non-GMP Products
CertiPro-L

The lineup includes products conforming to the Japanese Pharmacopoeia and Japanese Pharmaceutical Excipients (JPE). Non-compendial products (ingredients not listed in official compendia) are provided in accordance with our in-house specifications.
Features
- Lineup including products listed in the Japanese Pharmacopoeia and JPE, and non-compendial products
- ISO 9001 management

Features
CertiPro Product Lineup
Certificate of analysis
Product List
Related Information

Features

GMP management
With each product offering the document support as requested*1
Some products meet the USP (United States Pharmacopoeia) and Ph. Eur. (European Pharmacopoeia) in addition to the Japanese Pharmacopoeia, Japanese Pharmaceutical Codex, and Japanese Pharmaceutical Excipients*2

*1: To request information on ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities), etc., please contact individually. Information is provided partially for a fee depending on items.
*2: Products are controlled according to the latest versions.

CertiPro Product Lineup

Product Name	CAS RN^®	Grade	Conformity		Endotoxin	Package Size	Principal Use
Product Name	CAS RN^®	Grade	USP/NF	Ph.Eur.	Endotoxin	Package Size	Principal Use
Calcium Chloride Hydrate	10035-04-8	JP			-	500g	Stabilizer
Calcium Gluconate Hydrate	299-28-5	JP			Less than 1.5EU/g	500g	Calcium strengthener
Citric Acid Hydrate	5949-29-1	JP	✓	✓	Less than 8EU/g	500g	Stabilizer・Buffer
Citric Acid Hydrate	5949-29-1	JP	✓	✓	Less than 8EU/g	10kg	Stabilizer・Buffer
Dibasic Potassium Phosphate	7758-11-4	JPC			-	500g	Buffer
Dibasic Potassium Phosphate	7758-11-4	JPC			-	20kg	Buffer
Dibasic Sodium Phosphate Hydrate	10039-32-4	JP	✓	✓	Less than 0.2EU/g	500g	Buffer
Dibasic Sodium Phosphate Hydrate	10039-32-4	JP	✓	✓	Less than 0.2EU/g	10kg	Buffer
Disodium Edetate Hydrate	6381-92-6	JP			Less than 10EU/g	500g	Stabilizer
Disodium Edetate Hydrate	6381-92-6	JP			Less than 10EU/g	20kg	Stabilizer
Dried Sodium Carbonate	497-19-8	JP			Less than 10EU/g	500g	Buffer
Dried Sodium Carbonate	497-19-8	JP			Less than 10EU/g	10kg	Buffer
Glucose	50-99-7	JP			Less than 10EU/g	500g	Stabilizer
Glucose	50-99-7	JP			Less than 10EU/g	10kg	Stabilizer
Glycine	56-40-6	JP			Less than 10EU/g	500g	Stabilizer
Hydrochloric Acid	7647-01-0	JP		✓	Less than 10EU/mg	500mL	Stabilizer・Buffer
Lactose Hydrate	64044-51-5	JP			Less than 25EU/g	500g	Excipients
Magnesium Sulfate Hydrate	10034-99-8	JP			Less than 10EU/g	500g	Stabilizer
D-Mannitol	69-65-8	JP			-	500g	Stabilizer
Monobasic Potassium Phosphate	7778-77-0	JPC			-	500g	Buffer
Monobasic Potassium Phosphate	7778-77-0	JPC			-	25kg	Buffer
Potassium Chloride	7447-40-7	JP			-	500g	Buffer
Potassium Iodide	7681-11-0	JP			-	500g	Stabilizer・Soluble agent
Purified Glucose	50-99-7	JP	✓	✓	Less than 2EU/g	500g	Stabilizer
Purified Glucose	50-99-7	JP	✓	✓	Less than 2EU/g	10kg	Stabilizer
Sodium Acetate Hydrate	6131-90-4	JP			-	500g	Buffer
Sodium Bicarbonate	144-55-8			✓	Less than 10EU/mg	500g	Buffer
Sodium Bicarbonate	144-55-8			✓	Less than 10EU/mg	10kg	Buffer
Sodium Chloride	7647-14-5	JP	✓	✓	Less than 3.1EU/g	500g	Stabilizer・Buffer
Sodium Chloride	7647-14-5	JP	✓	✓	Less than 3.1EU/g	10kg	Stabilizer・Buffer
Sodium Citrate Hydrate	6132-04-3	JP	✓	✓	Less than 5.2EU/g	500g	Stabilizer・Buffer
Sodium Citrate Hydrate	6132-04-3	JP	✓	✓	Less than 5.2EU/g	10kg	Stabilizer・Buffer
Sodium Dihydrogen Phosphate Dihydrate	13472-35-0	JPE	✓	✓	Less than 2EU/g	500g	Buffer
Sodium Dihydrogen Phosphate Dihydrate	13472-35-0	JPE	✓	✓	Less than 2EU/g	10kg	Buffer
Sodium L-Glutamate Hydrate	6106-04-3	JPC	(NF)		Less than 3.9EU/g	500g	Stabilizer・Buffer
Sodium L-Glutamate Hydrate	6106-04-3	JPC	(NF)		Less than 3.9EU/g	20kg	Stabilizer・Buffer
Sodium Hydroxide	1310-73-2	JP	(NF)	✓	Less than 10EU/g	500g	Buffer
Sodium Hydroxide	1310-73-2	JP	(NF)	✓	Less than 10EU/g	10kg	Buffer
Sucrose	57-50-1	JP	(NF)	✓	Less than 2EU/g	500g	Stabilizer
Sucrose	57-50-1	JP	(NF)	✓	Less than 2EU/g	10kg	Stabilizer
Trometamol	77-86-1	JPC	✓	✓	Less than 0.03IU/g	500g	Buffer
Trometamol	77-86-1	JPC	✓	✓	Less than 0.03IU/g	10kg	Buffer
Urea	57-13-6	JP			-	500g	Stabilizer
Urea	57-13-6	JP			-	10kg	Stabilizer

Certificate of analysis

Certificate of analysis(CoA) of each product can be viewed in "Search CoAs".
Click here to see how to obtain CoAs.

Example of CoA

Product List

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Product content may differ from the actual image due to minor specification changes etc.