- TOP
- GMP compliant Products CertiPro
GMP compliant Products
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
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 | |
USP-NF | Ph.Eur. | ||||||||
Disodium Edetate Hydrate | 6381-92-6 | JP | Less than 10EU/g | 500 g | 046-34615 | Stabilizer | EN |
||
---|---|---|---|---|---|---|---|---|---|
20 kg | 042-34617 | ||||||||
Potassium Chloride | 7447-40-7 | JP | ー | 500 g | 163-22105 | Buffer | EN |
||
Calcium Chloride Hydrate | 10035-04-8 | JP | ー | 500 g | 030-19555 | Stabilizer | EN |
||
Sodium Chloride | 7647-14-5 | JP | ✓ | ✓ | Less than 3.1EU/g | 500 g | 194-18505 | Stabilizer・ Buffer |
EN |
10 kg | 190-18507 | ||||||||
Hydrochloric Acid | 7647-01-0 | JP | ✓ | Less than 10EU/g | 500 mL | 082-10475 | Stabilizer・ Buffer |
EN |
|
Dried Sodium Carbonate | 497-19-8 | JP | Less than 10EU/g | 500 g | 049-34345 | Buffer | EN |
||
10 kg | 045-34347 | ||||||||
Citric Acid Hydrate | 5949-29-1 | JP | ✓ | ✓ | Less than 8EU/g | 500 g | 032-25245 | Stabilizer・ Buffer |
EN |
Sodium Citrate Hydrate | 6132-04-3 | JP | ✓ | ✓ | Less than 5.2EU/g | 500 g | 197-18855 | Stabilizer・ Buffer |
EN |
10 kg | 193-18857 | ||||||||
Glycine | 56-40-6 | JP | ー | 500 g | 077-05095 | Stabilizer | EN |
||
Calcium Gluconate Hydrate | 299-28-5 | JP | Less than 1.5EU/g | 500 g | 030-25785 | Calcium strengthener | |
||
Sodium L-Glutamate Hydrate | 6106-04-3 | JPC | (NF) | ー | Less than 3.9EU/g | 500 g | 135-15555 | Stabilizer・ Buffer |
EN |
20 kg | 131-15557 | ||||||||
Sodium Acetate Hydrate | 6131-90-4 | JP | ー | 500 g | 197-13235 | Buffer | EN |
||
Sodium Hydroxide | 1310-73-2 | JP | (NF) | ✓ | Less than 10EU/g | 500 g | 190-18465 | Buffer | EN |
10 kg | 196-18467 | ||||||||
Sucrose | 57-50-1 | JP | (NF) | ✓ | Less than 2EU/g | 500 g | 198-18385 | Stabilizer | EN |
10 kg | 194-18387 | ||||||||
Purified Glucose | 50-99-7 | JP | ※3 | Less than 2EU/g | 500 g | 168-28515 | Stabilizer | EN |
|
10 kg | 164-28517 | ||||||||
Sodium Bicarbonate | 144-55-8 | JP | ✓ | Less than 10EU/g | 500 g | 197-18475 | Buffer | EN |
|
10 kg | 193-18477 | ||||||||
Sodium Thiosulfate Hydrate | 10102-17-7 | JP | ー | 500 g | 196-19165 | Stabilizer・ Solubilizer |
|
||
20 kg | 192-19167 | ||||||||
Trometamol | 77-86-1 | JPC | ✓ | ✓ | Less than 0.03IU/g | 500 g | 203-21035 | Buffer | EN |
10 kg | 209-21037 | ||||||||
Lactose Hydrate | 64044-51-5 | JP | ※3 | Less than 25EU/g | 500 g | 121-06685 | Excipients | EN |
|
Urea | 57-13-6 | JP | ー | 500 g | 213-01295 | Stabilizer | EN |
||
10 kg | 219-01297 | ||||||||
Glucose | 50-99-7 | JP | ー | 500 g | 076-05705 | Stabilizer | EN |
||
10 kg | 072-05707 | ||||||||
D-Mannitol | 69-65-8 | JP | ※3 | ー | 500 g | 133-14495 | Stabilizer | EN |
|
Potassium Iodide | 7681-11-0 | JP | ー | 500 g | 161-21925 | Stabilizer・ Soluble agent |
EN |
||
Magnesium Sulfate Hydrate | 10034-99-8 | JP | Less than 10EU/g | 500 g | 130-18925 | Stabilizer | EN |
||
Dibasic Sodium Phosphate Hydrate | 10039-32-4 | JP | ✓ | ✓ | Less than 0.2EU/g | 500 g | 047-34385 | Buffer | EN |
10 kg | 043-34387 | ||||||||
Dibasic Potassium Phosphate | 7758-11-4 | JPC | ー | 500 g | 047-29015 | Buffer | EN |
||
20 kg | 043-29017 | ||||||||
Monobasic Potassium Phosphate | 7778-77-0 | JPC | ー | 500 g | 136-14485 | Buffer | EN |
||
25 kg | 132-14487 | ||||||||
Sodium Dihydrogen Phosphate Dihydrate | 13472-35-0 | JPE | ✓ | ✓ | Less than 2.0EU/g | 500 g | 191-18495 | Buffer | EN |
10kg | 197-18497 |
※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.