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- CertiPro Series
- 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
- Product Specifications Sheet, SDS, and Certificate of Analysis can be obtained from the links for each product name.
- If there is a ✉ mark in the Statement column, it is currently being prepared, so please request it using the inquiry form at the link.
- For information about our Statement for pharmaceutical raw materials, click here.
- If you have any requests for dilution or changes in capacity, please contact us using the inquiry form.
| Product Name | CAS RN® | Grade | Conformity | Endotoxin | Package Size | Product Code | Principal Use | Statement | |
| USP-NF | Ph.Eur. | ||||||||
| Acetylcysteine | 616-91-1 | JP | ✓ | ✓ | Less than 10 EU/g |
10 kg | 013-28757 | Culture medium additive |
EN 
|
|---|---|---|---|---|---|---|---|---|---|
| Calcium Chloride Hydrate | 10035-04-8 | JP | Less than 2.5 EU/g |
500 g | 030-19555 | Stabilizer | EN |
||
| Calcium Gluconate Hydrate | 299-28-5 | JP | Less than 1.5 EU/g |
500 g | 037-26035 | Calcium strengthener |
EN
|
||
| 10 kg | 033-26037 | ||||||||
| Citric Acid Hydrate | 5949-29-1 | JP | ✓ | ✓ | Less than 8 EU/g |
500 g | 032-25245 | Stabilizer/ Buffer |
EN |
| Purified Glucose | 50-99-7 | JP | *3 | Less than 2 EU/g |
500 g | 168-28515 | Stabilizer | EN |
|
| 10 kg | 164-28517 | ||||||||
| Glucose | 50-99-7 | JP | ー | 500 g | 076-05705 | Stabilizer | EN |
||
| 10 kg | 072-05707 | ||||||||
| Glycine | 56-40-6 | JP | ✓ | ✓ | Less than 1.2 EU/g |
500 g | 075-06875 | Stabilizer | EN |
| New L-Histidine |
71-00-1 | JP | ✓ | ✓ | Less than 2.0 EU/g |
500 g | 083-10765 | Stabilizer/ Buffer |
EN 
|
| 20 kg | 089-10767 | ||||||||
| New L-Histidine Hydrochloride Hydrate |
5934-29-2 | JP | ー*4 | ✓ | Less than 2.0 EU/g |
500 g | 080-10775 | Stabilizer/ Buffer |
EN
|
| 20 kg | 086-10777 | ||||||||
| Hydrochloric Acid | 7647-01-0 | JP | ✓ | Less than 10 EU/g |
500 mL | 082-10475 | Stabilizer/ Buffer |
EN |
|
| Lactose Hydrate | 64044-51-5 | JP | *3 | Less than 25 EU/g |
500 g | 121-06685 | Excipients | EN |
|
| Magnesium Sulfate Hydrate | 10034-99-8 | JP | Less than 10 EU/g |
500 g | 130-18925 | Stabilizer | EN |
||
| D-Mannitol | 69-65-8 | JP | *3 | Less than 2.5 EU/g |
500 g | 133-14495 | Stabilizer | 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 |
||
| Dibasic Potassium Phosphate | 7758-11-4 | JPC | ✓ | ✓ | Less than 2.5 EU/g |
500 g | 047-29015 | Buffer | EN |
| 20 kg | 043-29017 | ||||||||
| Monobasic Potassium Phosphate | 7778-77-0 | JPC | (NF) | ✓ | ー | 500 g | 136-14485 | Buffer | EN |
| 25 kg | 132-14487 | ||||||||
| Sodium Acetate Hydrate | 6131-90-4 | JP | Less than 2.5 EU/g |
500 g | 197-13235 | Buffer | EN |
||
| Sodium Bicarbonate | 144-55-8 | JP | ✓ | ✓ | Less than 10 EU/g |
500 g | 199-19415 | Buffer |
EN
|
| 10 kg | 195-19417 | ||||||||
| Dried Sodium Carbonate | 497-19-8 | JP | (NF) | ✓ | Less than 10 EU/g |
500 g | 049-34345 | Buffer | EN |
| 10 kg | 045-34347 | ||||||||
| Sodium Chloride | 7647-14-5 | JP | ✓ | ✓ | Less than 3.1 EU/g |
500 g | 194-18505 | Stabilizer/ Buffer |
EN |
| 10 kg | 190-18507 | ||||||||
| Sodium Citrate Hydrate | 6132-04-3 | JP | ✓ | ✓ | Less than 5.2 EU/g |
500 g | 197-18855 | Stabilizer/ Buffer |
EN |
| 10 kg | 193-18857 | ||||||||
| Sodium Dihydrogen Phosphate Dihydrate | 13472-35-0 | JPE | ✓ | ✓ | Less than 2.0 EU/g |
500 g | 191-18495 | Buffer | EN |
| 10kg | 197-18497 | ||||||||
| Disodium Edetate Hydrate | 6381-92-6 | JP | Less than 10 EU/g |
500 g | 046-34615 | Stabilizer | EN |
||
| 20 kg | 042-34617 | ||||||||
| Sodium L-Glutamate Hydrate | 6106-04-3 | JPC | (NF) | ―*5 | Less than 3.9 EU/g |
500 g | 135-15555 | Stabilizer/ Buffer |
EN |
| 20 kg | 131-15557 | ||||||||
| Sodium Hydroxide | 1310-73-2 | JP | (NF) | ✓ | Less than 10 EU/g |
500 g | 190-18465 | Buffer | EN |
| 10 kg | 196-18467 | ||||||||
| Dibasic Sodium Phosphate Hydrate | 10039-32-4 | JP | ✓ | ✓ | Less than 0.2 EU/g |
500 g | 047-34385 | Buffer | EN |
| 10 kg | 043-34387 | ||||||||
| Sodium Thiosulfate Hydrate | 10102-17-7 | JP | Less than 10 EU/g |
500 g | 196-19165 | Stabilizer/ Solubilizer |
EN |
||
| 20 kg | 192-19167 | ||||||||
| Sucrose | 57-50-1 | JP | (NF) | ✓ | Less than 2 EU/g |
500 g | 198-18385 | Stabilizer | EN |
| 10 kg | 194-18387 | ||||||||
| Sucrose [Low endotoxin type (Less than 0.2 EU/g)] | 57-50-1 | JP | (NF) | ✓ | Less than 0.2 EU/g |
500 g | 197-19195 | Stabilizer | EN |
| 10 kg | 193-19197 | ||||||||
| Trometamol | 77-86-1 | JPC | ✓ | ✓ | Less than 0.03 IU/g |
500 g | 203-21035 | Buffer | EN |
| 10 kg | 209-21037 | ||||||||
| Urea | 57-13-6 | JP | Less than 2.5 EU/g |
500 g | 213-01295 | 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 USP-NF.
*5 This product is not listed in Ph.Eur.
