- Application for recombinant Insulin Human AF
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Why is purity so important for us?
We want to help our customers to ensure that they only use the best quality ingredients for the manufacturing of their products. Therefore we only manufacture in accordance to the highest cGMP standards and always use the best available synthetic raw materials from audited and approved suppliers.
Our process control – down to the finest detail – and our 65 years of know-how ensure maximum product purity, keeping impurities to even lower levels than pharmacopoeial standards.
An innovative synthesis process makes Novo Nordisk Pharmatech A/S a leading supplier of crystalline Quats for a wide range of applications. High levels of purity make them particularly suited for pharmaceutical applications, such as vaccine production. They act either as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams. Their purity and characteristics are also ideal for a range of personal care products. Whether FeF® Quats are used as excipients or APIs, you can rely on our product’s documented purity.
Recombinant Insulin Human AF
Recombinant Insulin Human AF consists of human insulin crystals, a biosynthetic white to almost white powder produced by a recombinant microbial expression in yeast with a synthetic gene insert. Insulin is a small and hydrophobic molecule and is easily dissolved in a buffer at relatively low pH. At neutral pH, insulin will take longer to dissolve:
• Solubility: Soluble at 10 mg/mL in pH 2-3
• Activity: ≥ 27.5 lU/mg (dry basis)
It is recommended to add dissolved insulin to the media while stirring. The recommended concentration of recombinant insulin in cell culture media is 1-10 mg/L, depending on cell type and specific application. Information sheet available on request.
Insulin Human AF has a shelf life of 60 months. It must be stored at -20°C ± 5°C to avoid potential degradation and to ensure compliance with the product specification for the entire shelf life period.
Insulin Human AF can be stored at refrigerator temperature (+2 to +8°C) for up to 14 days in total, accumulated over its shelf life period. Within the shelf life period, the product should not be thawed/re-frozen more than five times. In connection with dispensing the product, keeping and handling the product at up to 25°C is allowed for up to 24 hours.