Parenteral medicines

Aspartame is GRAS listed, and is accepted as a food additive in Europe and is in the FDA Inactive Ingredients Guide. It is included in non-parenteral medicines licensed in the UK, and is listed in the USP-NF, BP, JP, and EP. Aspartame is the subject of a monograph in the Food Chemicals Codex issued by the National Academy of Sciences. This document is very similar to the corresponding USP-NF monograph. 

Included in the FDA Inactive Ingredients Guide (dental preparations inhalations IM, IV, and SC injections nasal and ophthalmic preparations oral capsules, solutions, suspensions, syrups, and tablets rectal, topical, and transdermal preparations). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral and parenteral medicines licensed in the UK. 

Included in nonparenteral and parenteral medicines licensed in the UK. Widely used as an edible oil. 

Raw materials for production of parenteral medicines may not have a record of release of the batch older than two years, unless otherwise stipulated. 

The release documents issued for starting materials must not be older than five years. For the production of parenteral medicines, the release documents may not be older than two years. After this time expires, after retesting it is possible to issue a new protocol (certificate), if all inspection tests reveal satisfactory quality. The useabiirty of the starting substances on the basis of the new protocol (certificate) must be limited in time. 

There should be levels where validation and qualification should be performed, and the level should determine the intensity of these products. It should be least for liquid preparations (solutions) and most for parenteral medicines, and for solid dosage forms it should depend on the criticality of the product as far as the patient is concerned. 

FDA approved for intravenous, intravesical, intramuscular, subcutaneous, dental, and topical preparations. Included in parenteral medicines licensed in the United Kingdom... 

---