CertiPro

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

Pharmaceutical Raw Materials

GMP compliant Products CertiPro

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

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)

These products are classified into two categories depending on compliant standards: CertiPro (GMP compliant products) and CertiPro-L (ISO9001 compliant products).

CertiPro-L

CertiPro

Features

・GMP compliant
・Products listed in the JP, JPC, and JPE^＊1
・Conforming to the specifications in the USP and Ph. Eur. (depending on the product)^＊2

＊1 Information such as ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities) can be obtained from “Statement”. Please contact us for more details.
＊2 Specification of products reflects latest versions of pharmacopeia.

CertiPro Product Lineup

Click here for an explanation of our statement on pharmaceutical raw materials

Please contact us for individual requests regarding capacity.

Product Name	CAS RN®	Grade	Conformity		Endotoxin	Package Size	Product Code	Principal Use	Statement
Product Name	CAS RN®	Grade	USP-NF	Ph.Eur.	Endotoxin	Package Size	Product Code	Principal Use	Statement
Calcium Chloride Hydrate	10035-04-8	JP			ー	500 g	030-19555	Stabilizer	EN
Calcium Gluconate Hydrate	299-28-5	JP			Less than 1.5EU/g	500 g	037-26035	Calcium strengthener
Citric Acid Hydrate	5949-29-1	JP	✓	✓	Less than 8EU/g	500 g	032-25245	Stabilizer・ Buffer	EN
Dibasic Potassium Phosphate	7758-11-4	JPC			ー	500 g	047-29015	Buffer	EN
Dibasic Potassium Phosphate	7758-11-4	JPC			ー	20 kg	043-29017	Buffer	EN
Dibasic Sodium Phosphate Hydrate	10039-32-4	JP	✓	✓	Less than 0.2EU/g	500 g	047-34385	Buffer	EN
Dibasic Sodium Phosphate Hydrate	10039-32-4	JP	✓	✓	Less than 0.2EU/g	10 kg	043-34387	Buffer	EN
Disodium Edetate Hydrate	6381-92-6	JP			Less than 10EU/g	500 g	046-34615	Stabilizer	EN
Disodium Edetate Hydrate	6381-92-6	JP			Less than 10EU/g	20 kg	042-34617	Stabilizer	EN
Dried Sodium Carbonate	497-19-8	JP			Less than 10EU/g	500 g	049-34345	Buffer	EN
Dried Sodium Carbonate	497-19-8	JP			Less than 10EU/g	10 kg	045-34347	Buffer	EN
Glucose	50-99-7	JP			ー	500 g	076-05705	Stabilizer	EN
Glucose	50-99-7	JP			ー	10 kg	072-05707	Stabilizer	EN
Glycine	56-40-6	JP			Less than 3.1EU/g	500 g	077-05095	Stabilizer	EN
Hydrochloric Acid	7647-01-0	JP		✓	Less than 10EU/g	500 mL	082-10475	Stabilizer・ Buffer	EN
Lactose Hydrate	64044-51-5	JP	^＊3		Less than 25EU/g	500 g	121-06685	Excipients	EN
Magnesium Sulfate Hydrate	10034-99-8	JP			Less than 10EU/g	500 g	130-18925	Stabilizer	EN
D-Mannitol	69-65-8	JP	^＊3		ー	500 g	133-14495	Stabilizer	EN
Monobasic Potassium Phosphate	7778-77-0	JPC			ー	500 g	136-14485	Buffer	EN
Monobasic Potassium Phosphate	7778-77-0	JPC			ー	25 kg	132-14487	Buffer	EN
Potassium Chloride	7447-40-7	JP			ー	500 g	163-22105	Buffer	EN
Potassium Iodide	7681-11-0	JP			ー	500 g	161-21925	Stabilizer・ Soluble agent	EN
Purified Glucose	50-99-7	JP	^＊3		Less than 2EU/g	500 g	168-28515	Stabilizer	EN
Purified Glucose	50-99-7	JP	^＊3		Less than 2EU/g	10 kg	164-28517	Stabilizer	EN
Sodium Acetate Hydrate	6131-90-4	JP			ー	500 g	197-13235	Buffer	EN
Sodium Bicarbonate	144-55-8	JP		✓	Less than 10EU/g	500 g	197-18475	Buffer	EN
Sodium Bicarbonate	144-55-8	JP		✓	Less than 10EU/g	10 kg	193-18477	Buffer	EN
Sodium Chloride	7647-14-5	JP	✓	✓	Less than 3.1EU/g	500 g	194-18505	Stabilizer・ Buffer	EN
Sodium Chloride	7647-14-5	JP	✓	✓	Less than 3.1EU/g	10 kg	190-18507	Stabilizer・ Buffer	EN
Sodium Citrate Hydrate	6132-04-3	JP	✓	✓	Less than 5.2EU/g	500 g	197-18855	Stabilizer・ Buffer	EN
Sodium Citrate Hydrate	6132-04-3	JP	✓	✓	Less than 5.2EU/g	10 kg	193-18857	Stabilizer・ Buffer	EN
Sodium Dihydrogen Phosphate Dihydrate	13472-35-0	JPE	✓	✓	Less than 2.0EU/g	500 g	191-18495	Buffer	EN
Sodium Dihydrogen Phosphate Dihydrate	13472-35-0	JPE	✓	✓	Less than 2.0EU/g	10kg	197-18497	Buffer	EN
Sodium L-Glutamate Hydrate	6106-04-3	JPC	(NF)	―^＊4	Less than 3.9EU/g	500 g	135-15555	Stabilizer・ Buffer	EN
Sodium L-Glutamate Hydrate	6106-04-3	JPC	(NF)	―^＊4	Less than 3.9EU/g	20 kg	131-15557	Stabilizer・ Buffer	EN
Sodium Hydroxide	1310-73-2	JP	(NF)	✓	Less than 10EU/g	500 g	190-18465	Buffer	EN
Sodium Hydroxide	1310-73-2	JP	(NF)	✓	Less than 10EU/g	10 kg	196-18467	Buffer	EN
Sodium Thiosulfate Hydrate	10102-17-7	JP			Less than 10EU/g	500 g	196-19165	Stabilizer・ Solubilizer	EN
Sodium Thiosulfate Hydrate	10102-17-7	JP			Less than 10EU/g	20 kg	192-19167	Stabilizer・ Solubilizer	EN
Sucrose	57-50-1	JP	(NF)	✓	Less than 2EU/g	500 g	198-18385	Stabilizer	EN
Sucrose	57-50-1	JP	(NF)	✓	Less than 2EU/g	10 kg	194-18387	Stabilizer	EN
Trometamol	77-86-1	JPC	✓	✓	Less than 0.03IU/g	500 g	203-21035	Buffer	EN
Trometamol	77-86-1	JPC	✓	✓	Less than 0.03IU/g	10 kg	209-21037	Buffer	EN
Urea	57-13-6	JP			Less than 2.5EU/g	500 g	213-01295	Stabilizer	EN
Urea	57-13-6	JP			Less than 2.5EU/g	10 kg	219-01297	Stabilizer	EN

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

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