Y-27632

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Y-27632 (GMP-compliant)

This product is complied with ICH-Q7 (GMP for APIs) and is intended as a raw material for the commercial production of regenerative medicine products. It has been tested for viable count, as well as bacterial endotoxins, mycoplasma contamination, and residual solvent.

• GMP compliant
• Subdivision in a clean room equivalent to ISO14644-1 Class 6
• Reduction of contamination risk through the use of dedicated equipment for manufacturing culture media additives
• Process validation, analytical validation, and cleaning validation carried out
• Animal-derived-free

Y-27632, MF

This is an ISO9001-compliant product developed for the commercial manufacturing of regenerative medicine products. It has been tested for viable count, as well as bacterial endotoxins and mycoplasma contamination.
The management and manufacturing standards have been established internally.

• ISO9001 compliant
• Reduction of contamination risk through the use of dedicated equipment for manufacturing culture media additives
• Process validation, analytical validation, and cleaning validation carried out
• Animal-derived-free

CultureSure^® Y-27632

This product was developed for basic research in drug discovery and regenerative medicine. It has been tested for bacterial endotoxins and mycoplasma contamination.

• ISO9001 compliant
• Animal-derived-free

CultureSure^® 10 mmol/L Y-27632 Solution, Animal-derived-free

This product is a 10 mmol/L aqueous solution of CultureSure^® Y-27632. It has been tested for sterility, as well as bacterial endotoxins and mycoplasma contamination. It has been 0.1 μm filter-sterilized and can be added directly to the culture medium.

• ISO9001 compliant
• Animal-derived-free

GMP

Good Manufacturing Practice (GMP) is a standard for manufacturing and quality control of pharmaceutical drugs, etc., and should be observed by manufacturers of pharmaceutical drugs, etc.
The GMP standards are based on the following three principles:

1. Minimizing human errors during manufacture
2. Preventing contamination and quality deterioration of pharmaceutical products
3. Designing a system for high quality assurance

ICH-Q7 (GMP for APIs)

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international initiative to create guidelines on pharmaceutical regulations from scientific and technical perspectives by joint efforts of regulatory authorities and representatives of the pharmaceutical industry.

Among these guidelines, ICH-Q7 (GMP for APIs (Active Pharmaceutical Ingredients)) outlines the standard practices for manufacturing management and quality control related to active pharmaceutical ingredients.

ISO9001

ISO stands for the International Organization for Standardization, a non-governmental organization. The standards established by the ISO are referred to as ISO standards. These are internationally agreed-upon criteria established by experts, covering various areas such as product manufacturing, process management, service provision, and material supply.
ISO 9001 is a standard set out for quality management systems. Many companies and organizations are certified to ISO 9001 to ensure that their customers consistently receive good quality products and services.

The powder Y-27632 product has been confirmed to be soluble in water. After dilution, filter sterilize before use. Refer to the protocol at the top of this page for general usage in ES/iPS cell culture.

Amount of solvent when preparing solution