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
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)
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
- 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|
|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|
|Dibasic Potassium Phosphate||7758-11-4||JPC||-||500g||Buffer|
|Dibasic Sodium Phosphate Hydrate||10039-32-4||JP||✓||✓||Less than 0.2EU/g||500g||Buffer|
|Disodium Edetate Hydrate||6381-92-6||JP||Less than 10EU/g||500g||Stabilizer|
|Dried Sodium Carbonate||497-19-8||JP||Less than 10EU/g||500g||Buffer|
|Glucose||50-99-7||JP||Less than 10EU/g||500g||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|
|Monobasic Potassium Phosphate||7778-77-0||JPC||-||500g||Buffer|
|Potassium Iodide||7681-11-0||JP||-||500g||Stabilizer・Soluble agent|
|Purified Glucose||50-99-7||JP||✓||✓||Less than 2EU/g||500g||Stabilizer|
|Sodium Acetate Hydrate||6131-90-4||JP||-||500g||Buffer|
|Sodium Bicarbonate||144-55-8||✓||Less than 10EU/mg||500g||Buffer|
|Sodium Chloride||7647-14-5||JP||✓||✓||Less than 3.1EU/g||500g||Stabilizer・Buffer|
|Sodium Citrate Hydrate||6132-04-3||JP||✓||✓||Less than 5.2EU/g||500g||Stabilizer・Buffer|
|Sodium Dihydrogen Phosphate Dihydrate||13472-35-0||JPE||✓||✓||Less than 2EU/g||500g||Buffer|
|Sodium L-Glutamate Hydrate||6106-04-3||JPC||(NF)||Less than 3.9EU/g||500g||Stabilizer・Buffer|
|Sodium Hydroxide||1310-73-2||JP||(NF)||✓||Less than 10EU/g||500g||Buffer|
|Sucrose||57-50-1||JP||(NF)||✓||Less than 2EU/g||500g||Stabilizer|
|Trometamol||77-86-1||JPC||✓||✓||Less than 0.03IU/g||500g||Buffer|
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
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For research use or further manufacturing use only. Not for use in diagnostic procedures.
Product content may differ from the actual image due to minor specification changes etc.
If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.