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- ISO 9001 compliant Products CertiPro-L
ISO 9001 compliant Products
CertiPro-L
FUJIFILM Wako Pure Chemical provides pharmaceutical raw materials that can be used in the manufacturing process of pharmaceutical products. CertiPro-L is a series of pharmaceutical raw materials which is manufactured under ISO9001.
Pharmaceutical Raw Materials
ISO 9001 compliant Products CertiPro-L
Pharmaceutical raw materials manufactured under ISO 9001.
The lineup includes products conforming to the Japanese Pharmacopoeia (JP) and Japanese Pharmaceutical Excipients (JPE). Non-compendial products not listed in official compendia are provided in accordance with our own specifications.
Features
- ・Lineup including products listed in the Japanese Pharmacopoeia and JPE, and non-compendial products
- ・ISO 9001 compliant
These products are classified into two categories depending on management standards: CertiPro (GMP management products) and CertiPro-L (ISO9001 management products).
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.
- ・ISO 9001 compliant
- ・With each product offering the document support as requested＊1
＊1 Please contact us for information such as ICH-Q3C (residual solvents) and ICH-Q3D (elemental impurities).
CertiPro-L Product Lineup
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. | ||||||||
| 2-Amino-2-hydroxymethyl-1,3-propanediol Hydrochloride | 1185-53-1 | ― | Max.10EU/g | 500 g | 012-28445 | Buffer |  |
||
|---|---|---|---|---|---|---|---|---|---|
| 10 kg | 018-28447 | ||||||||
| Disodium Hydrogen Phosphate Anhydrous | 7558-79-4 | JPE | Less than 2.5EU/g | 500 g | 048-29665 | Buffer | EN  |
||
| 10 kg | 044-29667 | ||||||||
| Fumaric Acid | 110-17-8 | JPE | ―＊2 | 500 g | 068-05105 | Buffer | EN |
||
| 20 kg | 064-05107 | ||||||||
| Glucono-δ-Lactone | 90-80-2 | JPE | ―＊2 | Less than 2.0EU/g | 500 g | 075-05155 | Buffer | EN |
|
| Magnesium Stearate | 557-04-0 | JP | ＊3 | 500 g | 136-15105 | Lubricant | EN |
||
| Methyl Parahydroxybenzoate | 99-76-3 | JP | ＊3 | 5 kg | 857-40412 | Preservative | |
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| Polysorbate20 | 9005-64-5 | JPE | 25 g | 168-22792 | Stabilizer | EN |
|||
| Potassium Acetate | 127-08-2 | JPE | 500 g | 169-21965 | Buffer | EN |
|||
| Propyl Parahydroxybenzoate | 94-13-3 | JP | ＊3 | 5 kg | 857-40532 | Preservative | |
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| Sodium Bisulfite | 7631-90-5 | JP | ―＊2 | 500 g | 198-13265 | Stabilizer・Buffer | EN |
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| 20 kg | 194-13267 | ||||||||
| Sodium Dextran Sulfate 5000 | 9011-18-1 | ― | Less than 50EU/g | 25 g | 196-19182 | special use | EN |
||
| 500 g | 190-19185 | ||||||||
| Sodium Dihydrogen Phosphate Anhydrous | 7558-80-7 | JPE | ―＊2 | Less than 2.0EU/g | 500 g | 194-14105 | Buffer | EN |
|
| 10 kg | 190-14107 | ||||||||
| Sodium L-Tartrate | 6106-24-7 | JPE | ―＊2 | 500 g | 197-13975 | Buffer | EN |
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| Sodium Pyrosulfite | 7681-57-4 | JP | 500 g | 193-14055 | Preservative | EN |
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| 10 kg | 199-14057 | ||||||||
| Titanium Oxide | 13463-67-7 | JP | 500 g | 204-16055 | Excipients | EN |
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| 10 kg | 903-40303 | EN |
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＊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 check the product specifications.
