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Gibco™ RPMI 1640 is unique from other media because it contains the reducing agent glutathione and high concentrations of vitamins. RPMI 1640 contains biotin, vitamin B12 and PABA which are not found in Eagle's Minimal Essential Medium or Dulbecco's Modified Eagle Medium. In addition, the vitamins inositol and choline are present in very high concentrations.
Product Intended Use:
For in vitro diagnostic use. CAUTION: Not for human or animal therapeutic use. Uses other than the intended use may be a violation of local law. Customers using Gibco™ RPMI 1640 in a manufacturing process, who have a submission with the FDA, may request a letter of authorization from Life Technologies to reference our Type II Drug Master File (DMF).
cGMP Manufacturing and Quality System:
Gibco™ RPMI 1640 is manufactured at a cGMP compliant facility, located in Grand Island, New York. The facility is registered with the FDA as a medical device manufacturer and is certified to ISO 13485 standards. For supply chain continuity, Life Technologies offers an identical Gibco™ RPMI 1640 product made in our Scotland facility (13018-015). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.
RPMI 1640 contains no proteins, lipids, or growth factors. Therefore, RPMI 1640 requires supplementation, commonly with 10% Fetal Bovine Serum (FBS). RPMI 1640 uses a sodium bicarbonate buffer system (2.0 g/L) and therefore requires a 5-10% CO2 environment to maintain physiological pH.